EFFECTS OF MUSIC THERAPY VS.

MUSIC MEDICINE ON PHYSIOLOGICAL

AND PSYCHOLOGICAL PARAMETERS OF INTENSIVE CARE PATIENTS: A

RANDOMIZED CONTROLLED TRIAL

A Dissertation
Submitted to
the Temple University Graduate Board
________________________________________________________________________

in Partial Fulfillment
of the Requirements for the Degree
DOCTOR OF PHILOSOPHY
________________________________________________________________________

by
Carol L Shultis
May, 2012

Examining Committee Members:

Cheryl Dileo, Advisory Chair, Music Therapy

Darlene Brooks, Music Therapy
Cynthia Folio, Music Studies
Edward Flanagan, Boyer College of Music & Dance
 UMI Number: 3510346

All rights reserved

INFORMATION TO ALL USERS

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In the unlikely event that the author did not send a complete manuscript
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a note will indicate the deletion.

UMI 3510346
Copyright 2012 by ProQuest LLC.
All rights reserved. This edition of the work is protected against
unauthorized copying under Title 17, United States Code.

ProQuest LLC.
789 East Eisenhower Parkway
P.O. Box 1346
Ann Arbor, MI 48106 - 1346
 UMI Number: 3510346

All rights reserved

INFORMATION TO ALL USERS

The quality of this reproduction is dependent on the quality of the copy submitted.

In the unlikely event that the author did not send a complete manuscript
and there are missing pages, these will be noted. Also, if material had to be removed,
a note will indicate the deletion.

UMI 3510346
Copyright 2012 by ProQuest LLC.
All rights reserved. This edition of the work is protected against
unauthorized copying under Title 17, United States Code.

ProQuest LLC.
789 East Eisenhower Parkway
P.O. Box 1346
Ann Arbor, MI 48106 - 1346
 ii

ABSTRACT

This randomized controlled trial examined the effects of Music Therapy (MT),

Music Medicine (MM), or Attention Control (AC) on physiological and psychological

parameters of stress for adult and older adult patients receiving care in the Intensive Care

Unit of a community general hospital. Previous studies have indicated effectiveness of

music therapy or music medicine for these medical patients, but few data are available for

music therapy interventions. This study was an attempt to add to available information

about the effects of music therapy compared to the effects of music medicine or attention

control for this patient population. Participants (twenty-eight adults, ranging in age from

37-83 years; not mechanically ventilated at the time of session) were randomly assigned

to music therapy, music medicine or the attention control group. Repeated measures of

heart rate, blood pressure, respiratory rate, oxygen saturation, and anxiety and pain levels

were collected before the session, immediately after the session and at 60 minutes post-

session. Anxiety was measured using the Faces Anxiety Scale, and pain was self-

reported via a Visual Analog Scale. Post-session length of stay was collected from the

participants medical records. Overall, there were no significant interactions among study

groups and outcome measures. There was a statistically significant difference between

length of stay for music therapy participants and attention control. Over time from pre-

session to post-session, statistically significant decreases in anxiety scores were measured

for both music medicine and music therapy groups. Pain scores decreased for both music

medicine and music therapy groups, however not significantly. Some medically

beneficial effects of music therapy or music medicine were evident in the data.
 iii

ACKNOWLEDGEMENTS

With sincere thanks from the depths of my heart and soul to all who journeyed with me -

To Dr. Cheryl Dileo, for her wisdom and sustained support throughout this project; this

work would not have been completed without her advice, guidance and perseverance.

To Dr. Darlene Brooks, Dr. Cynthia Folio and Dr. Edward Flanagan for valuable

feedback and perspective which expanded my thinking about this project.

To Temple music therapy faculty: Dr. Kenneth Bruscia for his on-going support and

wise counsel, to Dr. Kenneth Aigen for his questions and to Dr. Wendy Magee for her

advice.

To Dr. Michael Hansen, Debra Bayer, RN and the staff of the Intensive Care Unit of

Western Pennsylvania Hospital, Forbes Regional Campus in Monroeville, PA, for your

openness to having music therapy research on your unit. Your support and input were an

integral part of my learning.

To Melyssa Weller and Michelle Muth, for your assistance as data collectors for this

research; I could not have done this without you. Your assistance in providing music

therapy treatment to other ICU patients was appreciated as well.

To the thousands of medical patients I have been privileged to treat over the past 30

years, I offer my deepest gratitude and appreciation. You allowed me to share in your

struggles and triumphs and taught me about the power of music and my role as a music

therapist.

Special thanks to Dr. Jennifer Cromley, Temple University College of Education, for

sharing her knowledge and teaching me to appreciate and understand statistical analysis.
 iv

To Eric Ruggieri for his statistical advice and patient listening ear as I found my way

along the analytic path.

I acknowledge with gratitude my fellow travels on this PhD journey, both the doctoral

and the masters students who shared the graduate office, challenged my thinking and

exchanged ideas all while helping me to maintain balance in the face of many academic

and research responsibilities.

Thanks also to my music therapy colleagues and friends who served as cheerleaders

along the way, keeping me moving forward when lifes obstacles and responsibilities

threatened to sidetrack my efforts.

Most importantly, I am thankful for my husband Gary, for sustaining our family through

these years of academic work, doing the laundry and making the phone calls and offering

his unique perspective on the work I faced.

 v

TABLE OF CONTENTS

ABSTRACT ...................................................................................................................... II

ACKNOWLEDGEMENTS ........................................................................................... III

TABLE OF CONTENTS ................................................................................................ V

LIST OF TABLES ........................................................................................................ XII

LIST OF FIGURES .......................................................................................................XV

CHAPTER 1 ...................................................................................................................... 1

HEALTH, STRESS AND MUSIC .................................................................................. 1

Understanding the Mind/Body Connection .................................................................... 1

Stress and Illness ............................................................................................................... 3

Stress and Intensive Care Unit Treatment ..................................................................... 4

Non-Pharmacologic Treatment of ICU Stress ............................................................... 5

Music in the ICU ............................................................................................................... 6

CHAPTER 2 .................................................................................................................... 13

REVIEW OF LITERATURE ........................................................................................ 13

 vi

Understanding Stress in Intensive Care Treatment .................................................... 13

ICU Cost Factors........................................................................................................... 13

Prevalence and Causes of Stress in the ICU ................................................................. 14

Psychological Impact ...................................................................................................... 19

Adverse Outcomes .......................................................................................................... 19

Music Medicine for Stress Management....................................................................... 21

Music and Heart Rate.................................................................................................... 28

Music and Blood Pressure ............................................................................................ 29

Music and Respiration Rate .......................................................................................... 30

Music and Oxygen Saturation ....................................................................................... 30

Music and Pain Management ........................................................................................ 31

Music and Anxiety Management .................................................................................. 31

Music and Length of Stay in ICU ................................................................................. 32

Music Therapy Studies ................................................................................................... 32

Music Therapy and Heart Rate ..................................................................................... 32

Music Therapy and Blood Pressure .............................................................................. 33

Music Therapy and Respiration Rate ............................................................................ 33

Music Therapy and Oxygen Saturation ........................................................................ 33

Music Therapy and Pain Management ......................................................................... 33

Music Therapy and Anxiety Management .................................................................... 34

 vii

Music Therapy and Length of Stay in ICU ................................................................... 34

Rationale for Current Study .......................................................................................... 34

Research Questions ......................................................................................................... 35

CHAPTER 3 .................................................................................................................... 37

RESEARCH METHOD ................................................................................................. 37

Participants ...................................................................................................................... 37

Setting and Recruitment ................................................................................................ 37

Procedure ......................................................................................................................... 38

Design ........................................................................................................................... 38

Procedures for Study Approval ..................................................................................... 39

Procedures for Random Assignment ............................................................................ 39

Procedures for Implementation ..................................................................................... 40

Session Procedures........................................................................................................ 41

Music Medicine Group (MM) .................................................................................. 41

Music Listening Selections ....................................................................................... 42

Music Therapy Group (MT) ..................................................................................... 44

Befriending/Attention Control Group (AC).............................................................. 48

Measures .......................................................................................................................... 49

Dependent Variables ..................................................................................................... 49

 viii

Data Collection ................................................................................................................ 51

Equipment ....................................................................................................................... 53

CHAPTER 4 .................................................................................................................... 55

RESULTS ........................................................................................................................ 55

DATA ANALYSIS .......................................................................................................... 55

Randomized Allocation .................................................................................................. 57

Follow-Up......................................................................................................................... 57

Analysis ............................................................................................................................ 57

Analysis ............................................................................................................................ 57

Musical Demographics ................................................................................................... 58

Decision Tree Procedures ............................................................................................... 59

Physiological Measures ................................................................................................... 61

Heart Rate Data Analysis .............................................................................................. 63

Blood Pressure Data Analysis ....................................................................................... 65

Respiratory rate data analysis. ...................................................................................... 68

Oxygen Saturation Data Analysis ................................................................................. 70

Psychological Measures .................................................................................................. 72

 ix

Anxiety Scores Data Analysis ...................................................................................... 72

Pain Scores Data Analysis ............................................................................................ 75

Pain level was measured using a Visual Analog scale. These data were collected by the

researcher immediately prior to the research condition and repeated by a student

research assistant after the research condition and at 60 minutes post session. ........... 75

Length of Stay Data Analysis ......................................................................................... 77

CHAPTER 5 ................................................................................................................... 81

DISCUSSION .................................................................................................................. 81

Description of Participants............................................................................................. 81

Heart Rate Discussion..................................................................................................... 83

Blood Pressure Discussion .............................................................................................. 84

Respiratory Rate Discussion .......................................................................................... 85

Oxygen Saturation Discussion ....................................................................................... 86

Anxiety Scores Discussion .............................................................................................. 87

Pain Scores Discussion .................................................................................................... 89

Length of Stay as a Dependent Variable....................................................................... 90

Music Choices and Interventions .................................................................................. 91

 x

Methodological considerations ...................................................................................... 93

Potential Intervening Variables..................................................................................... 93

Practical Problems ........................................................................................................ 94

Limitations of the Study ................................................................................................. 97

Implications for Research .............................................................................................. 99

Implications for Clinical Practice ................................................................................ 100

Implications for Education and Training ................................................................... 101

Recommendations for Future Research ..................................................................... 104

REFERENCES .............................................................................................................. 109

APPENDIX A ................................................................................................................ 151

REQUEST FOR PROTOCOL REVIEW .................................................................. 151

APPENDIX B ................................................................................................................ 162

RESEARCH SUBJECT INFORMATION CONSENT FORM ............................... 162

APPENDIX C ................................................................................................................ 169

DEMOGRAPHIC/MUSIC QUESTIONNAIRE ........................................................ 169

 xi

APPENDIX D ................................................................................................................ 170

MUSIC THERAPY GROUP PARTICIPANT SONG LYRICS .............................. 170

 xii

LIST OF TABLES

Table 1 ................................................................................................................................ 9

Sampling of experimental use of music with medical patients. .................................... 9

Table 2 .............................................................................................................................. 23

Effect Size for Cardiology/ICU Studies from Dileo & Bradts Meta-Analysis (2005)

................................................................................................................................... 23

Table 3 .............................................................................................................................. 25

Music Medicine Research 2004 and beyond Cardiology/ICU and Surgical

specializations only.................................................................................................. 25

Table 4 .............................................................................................................................. 44

Music programs used for music medicine intervention .............................................. 44

Table 5 .............................................................................................................................. 53

Data Collection Points .................................................................................................... 53

Table 6 .............................................................................................................................. 59

Music Genre Preferences by Group .............................................................................. 59

Table 7 .............................................................................................................................. 60

Music Therapy Interventions......................................................................................... 60

Table 8 .............................................................................................................................. 61

Baseline Analysis of Variance ........................................................................................ 61

Table 9 .............................................................................................................................. 62

Multivariate ANOVA for Physiological Dependent Variables a................................ 62

Table 10 ............................................................................................................................ 63
 xiii

Repeated Measures ANOVA for Heart Rate a ............................................................. 63

Table 11 ............................................................................................................................ 64

Mean Heart Rate Scores by Treatment Group ............................................................ 64

Table 12 ............................................................................................................................ 66

Repeated Measures ANOVA for Blood Pressure Means a .......................................... 66

Table 13 ............................................................................................................................ 67

Mean Arterial Blood Pressure Scores by Treatment Group ...................................... 67

Table 14 ............................................................................................................................ 68

Repeated Measures ANOVA for Respiratory Rate a................................................... 68

Table 15 ............................................................................................................................ 69

Mean Respiratory Rate Scores by Treatment Group ................................................. 69

Table 16 ............................................................................................................................ 70

Repeated Measures ANOVA for Oxygen Saturation a................................................ 70

Table 17 ............................................................................................................................ 71

Mean Oxygen Saturation Scores by Treatment Group............................................... 71

Table 18 ............................................................................................................................ 73

Repeated Measures ANOVA for Faces Anxiety Scores a ............................................ 73

Table 19 ............................................................................................................................ 73

Student t-test comparisons of pre-session to post session anxiety score changes ...... 73

Table 20 ............................................................................................................................ 74

Mean Anxiety Scores by Treatment Group.................................................................. 74

Table 21 ............................................................................................................................ 75
 xiv

Repeated Measures ANOVA for Pain Scores a ............................................................ 75

Table 22 ............................................................................................................................ 77

Mean Pain Scores by Treatment Group ....................................................................... 77

Table 23 ............................................................................................................................ 77

Student t-test comparisons of pre-session to post session pain score changes........... 77

Table 24 ............................................................................................................................ 78

One-way ANOVA length of stay a ................................................................................. 78

Table 25 ............................................................................................................................ 80

Kruskal-Wallis One-way ANOVA of Ranks for length of stay .................................. 80

Table 26 ............................................................................................................................ 80

Mean Length of Stay (in hours) by Treatment Group ................................................ 80

 xv

LIST OF FIGURES

Figure 1 Session Protocol .............................................................................................. 47

Figure 2 Participant Recruitment and Allocation ...................................................... 57

Figure 3 Heart Rate Scores ............................................................................................ 64

Figure 4 Mean Arterial Blood Pressure ........................................................................ 67

Figure 5 Respiratory Rates ............................................................................................ 69

Figure 6 Oxygen Saturation ........................................................................................... 71

Figure 7 Anxiety Scores .................................................................................................. 74

Figure 8 Pain Scores ....................................................................................................... 76

Figure 9 Length of Stay .................................................................................................. 78

 CHAPTER 1

HEALTH, STRESS AND MUSIC

Understanding the Mind/Body Connection

Modern day understanding of health has changed. Over the past 30 years,

research and writings have altered the knowledge of what is required to maintain or

restore health. After decades of dependence on the medical model, professionals have

begun to acknowledge the contributions of psychosocial factors to both health and illness.

Perhaps the most striking change is the current understanding of the linkages between

health, stress, emotion and the individuals social context. Referred to as mind-body,

complementary, alternative or integrative medicine or psychoneuroimmunology, this

movement is based on scientific research that supports knowledge of the

interrelationships among thoughts, emotions, social support, spiritual factors and physical

well-being (National Institutes of Health, 2007).

A central focus of past and current research has been the impact of stress on mind,

body and spirit, making stress a major health risk factor (Van Itallie, 2002). Stress has

been examined from many perspectives, including attitude, anxiety, sleep disorders,

social relationships, support networks and loss (Karren, Hafen, Smith & Frandsen, 2002).

This research has shifted the traditional understanding of illness and medicine, producing

evidence that mind, body and spirit may play as significant a role in health as do bacteria,

viruses and physical changes.

 2

In 1985, neuroscientist Candace Pert introduced her ground-breaking research,

which demonstrated a link between emotions and cellular activity throughout the body.

She boldly declared, Emotion happens at a cellular level. She discovered that receptor

sites for neuropeptides were involved in emotional response and that these clustered not

only in the brain, but also in the spinal cord. Thus, neuropeptide receptors appear to be a

communication pathway for information from all senses, sights, sounds, smells, tastes

and touch into the brain. The number of neuropeptide receptors found outside the limbic

system suggests a biofeedback-like loop between the mind and the body (Pert, 1988).

Subsequent research has demonstrated that the neuropeptide receptor network provides

bidirectional communication between the immune and nervous systems (Pert, Dreher &

Ruff, 1998). Her pronouncement was part of a new awakening in the health care world

as many practitioners began to incorporate treatments and approaches outside the

traditional medical model. For example, psychosocial interventions emphasizing

emotional expression or active coping have been found to have positive health benefits

(McGregor & Antoni, 2009; Pert, et al., 1998).

Research in the area of psychoneuroimmunology provides a greater understanding

of how the body can communicate emotions at a physical level, that is, the mind-body

connection. Supporting this psychological, physiological connection is the work of

Young (1973, in Radocy & Boyle, 1988) wherein he describes emotion as a state which

originates in the psychological situation and which is revealed by marked bodily changes

in smooth muscles, glands, and gross behaviors (p. 196). This definition suggests that
 3

emotions are experienced as temporary states of being that are manifested

physiologically.

Although hormones from the endocrine system are the most familiar

physiological connection to psychological responses, the nervous system also is affected;

this influences its production of white blood cells. A third physical response involves

communication molecules which include neuropeptides, neurotransmitters, growth

factors, and cytokines. Cytokines influence cellular activity, cell division and genetic

functioning; thus emotion has a direct influence on how the body functions (Dhabhar,

2002; Simonton & Henson, 1992). Dantzer (2005) explores the role of brain cytokines in

the organization of subjective, behavioral and metabolic responses to the perception and

representation of bodily symptoms. These cytokines serve as communication and

activation of our immune system and play a role in both the physiological response and

our cognition of well-being and symptoms of illness (Moon, McNeil, & Greund, 2011).

Stress and Illness

Research in the past 30 years has supported the significant role stress plays in

health. Studies have revealed physiological changes in individuals facing unemployment

(Arnetz, et al., 1991), in workers faced with negative job stressors (Di Donato, et al.,

2006), in students and adults presented with stressful tasks (Benschop, Jacobs &

Sommers, 1996; Cacioppo, et al., 1995; Kiecolt-Glaser, et al., 1984) and psychological

stress (Kendall-Tackett, 2009; Schedlowski, et al., 1995; Cohen, Tyrrell, & Smith, 1991;

Jemmontt & Locke, 1984). These physiological reactions include cardiac changes

(Cacioppo, et al., 1995; Uchino, Cacioppo, Malarkey, & Glaser, 1995), hormone
 4

production changes (Dhabhar, 2002; Arnetz, et al., 1991) and alterations in the immune

system (Biller & Daniels, 1998; Dhabar & McEwen, 1997; Keresztes, Rudisch, Tajti,

Ocsovszki, & Gardi, 2007; Kiecolt-Glaser, et al., 1984; Glaser, et al., 1985; Keicolt-

Glaser, et al., 1986; Bachen, et al., 1992). There is evidence that stress contributes to and

exacerbates illnesses, including asthma (Turyk, et al., 2008) and Crohns disease (Bitton,

et al., 2008), among others. Kendall-Tackett (2009) explored the underlying mechanisms

linking the stress of traumatic events with a higher than usual incidence of cardiovascular

disease, diabetes, gastrointestinal problems and cancers. The research suggests that stress

causes a dysregulation in hormonal and sympathetic nervous systems which can alter the

bodys inflammatory response. Key components of the immune system are also activated

in response to stressors that are demonstrated by measurable changes in the

hypothalamic-pituitary-adrenal axis reactivity (Wetherell, et al., 2006).

Whereas stress associated with illness is detrimental to health, hospitalization to

treat illnesses adds additional stressors that further complicate recovery (Ben-Menachem,

et al., 1994; Fontana, Kerns, Rosenberg, & Colonese, 1989; Frasure-Smith, 1991;

Karademas, Tsagarai, & Lambrou, 2009).

Stress and Intensive Care Unit Treatment

The manner in which stress impacts health and recovery is crucial to patients

receiving hospital care, especially in the intensive care unit (ICU). Much research has

examined the effects of various stressors on the ICU patient, revealing effects on

response to treatment (Malan, 1992; Perrins, King, & Collings, 1998; Yau, Rohatiner,
 5

Lister, & Hinds, 1991), mental attitude toward treatment (Novaes, Aronovich, Ferraz, &

Knobel, 1997) and psychological difficulties (Nasraway, 2001).

Stressors associated with illness when added to the environmental stressors of the

ICU can be a source of negative clinical outcomes (Cochran & Ganong, 1989). Patients

are negatively impacted by stressors linked to illness and physical discomfort (Bowers,

2004; Cornock, 1998; Novaes, et al., 1997), and many experience stress-related

symptoms long after discharge from the ICU (Campbell, 1995; Hellgren & Stahle, 2005;

Mayou & Smith, 1997; Perrins, et al., 1998). The significant effects of stress on patient

outcomes, both during the ICU stay and after discharge, highlight the importance of

exploring methods to decrease the distress of illness and intensive care.

Non-Pharmacologic Treatment of ICU Stress

The growing evidence that stress has an impact on health, coupled with the

knowledge that sedative medication use may address some symptoms but cause

additional complications (Nelson, Weinert, Bury, Marinelli, & Gross, 2000), points to an

urgent need for ways to address the negative effects of stress for medical patients non-

pharmacologically. Stress management techniques have been used for hospitalized

adults diagnosed with chronic obstructive pulmonary disease (Fuchs-Climent, Le Gallais,

Varray, Desplan, Cadopi, & Prefaut, 1999; Young, Dewse, Ferguson, & Kolbe, 1999),

congestive heart failure and myocardial infarctions (Baer, Cleveland, Monteiro, Revel,

Clancy, & Bowen, 1985; Kanji, White, & Ernst, 2004), and for preoperative patients

(Augustin & Hains, 1996; Berg, Fleischer, Koller, & Neubert, 2006; Leinonen & Leino-

Kilpi, 1999; Markland & Hardy, 1993). Relaxation training has also been a component of
 6

treatment for patients after cardiac surgery (Dehdari, Heidamia, Ramezankhani,

Sadeghian, & Ghofranipour, 2009) and angioplasty (Kanji, et al., 2004). Techniques

employed include autogenic training, breathing exercises and cognitive behavioral

interventions, as well as pre-operative education (Benton & Avery, 1993; Gammon &

Mulholland, 1996; Meeker, 1994; Meeker, Rodriguez, & Johnson, 1992). Religious

beliefs and practices also play a significant role in helping patients cope with illness.

Koenig (1998) found that nearly 90% of 337 patients reported that faith-based practices

played a role in helping them cope with hospitalization, and that 40% found them to be

an important factor.

Current stress management literature contains an extensive discussion of the use

of relaxation techniques (DeMarco, 2000; Manzoni, Pagnini, Castelnuovo, & Molinari,

2008; van Dixhoorn & White, 2005), including autogenic relaxation, progressive muscle

relaxation, breathing techniques, prayer and meditation, and changes in attitude or

perspective as a means to reduce stress. Music listening has also been used as a stress

management technique for hospitalized patients (Ebneshahidi, & Mohseni, 2008; Han, et

al., 2010).

Music in the ICU

Both medical professionals and music therapists have investigated the use of

music in medical environments, including the ICU, as a means of helping patients to

manage stress. The use of recorded music with this population has resulted in

physiological changes associated with decreased stress response (Chan, Chung, Chung &

Lee, 2008) and decreases in psychological measures of anxiety (Chlan, Engeland,

 7

Anthony, & Guttormson, 2007; Lee, Chung, Chan & Chan, 2005; Sendelbach, Halm,

Doran, Miller, & Gaillard, 2006; Twiss, Seaver, & McCaffrey, 2006; Voss, Good, Yates,

Baun, Thompson, & Hertzog, 2004). These studies demonstrate the impact of music on

positive physiological changes, most specifically systolic and diastolic blood pressure,

heart rate, respiratory rate and oxygen saturation. Other studies offer evidence that music

or music therapy may have a beneficial effect on psychological variables, especially

anxiety and depression (See Table 1). The majority of these studies have used recorded

music listening (without the use of trained music therapists) as the intervention. Few if

any studies have compared the effectiveness of the use of recorded music listening with

music therapy. Thus, there is a need for such studies (Dileo & Bradt, 2005). For the

purposes of this discussion, pre-recorded music listening will be defined as music

medicine. Dileo (1999) defines music medicine as a non-pharmacological intervention

addressing stress, anxiety and/or pain using music as a receptive technique. Music

medicine is used as an adjunct to medical treatment. The patient listens to music

preselected by medical staff or selected by the patient from available programs. This

music may be selected from many different genres and styles, may be especially

composed, may use low frequencies or use combinations of these characteristics (p. 4).

Music therapy is used in this study to refer to a therapeutic process including a

music therapist and a relationship developed through the music experience (Dileo, 1999,

p. 4). Music therapy includes a variety of experiences including receptive, recreational,

improvisational, and compositional activities. Both the music and therapeutic

relationship serve as healing components which address the whole patient on many levels
 8

rather than just the presenting medical condition or procedure. Music therapy may be a

primary intervention, may work in partnership with medical care or may be supportive in

nature (p. 5).

 9

Table 1
Sampling of experimental use of music with medical patients.
Authors Pt Sample Independent Dependent Addl
Popul Size Variables Variables D var/
** Sig results X not measured Comments
HR RR BP Ox Anx Pain Mood
Davis-Rollans & CCU 24 Classical music ** X ** Change in HR
Cunningham 3 pieces 42 not seen as
1987 minutes clinically
Significant
Guzzetta CCU 80 Acute 3 tapes /20 min ** Finger temp
1989 MI Pop, Non-trad,
Classical
Bolwerk, C. Acute 22 minutes of **
Lueders (1990). MI classical music
Updike, 1990 ICU 20 X ** ** ** **
CHK patients
Heitz Post-op 60 x More pleasant
1992 patients w/music
Baranson CABG pts 96 5 cassettes vs. ** ** X **
1995 DVD vs. rest
Mockel, Stork, healthy and 20 each Strauss waltz, ** acute stress-
Vollert, Rocker, hypertensiv group Modern piece related effects
Danne, Hochrein, e subjects by Henze & in both
Eichstadt, & Frei, meditative hypertensives
1995 piece by and healthy,
Shankar most marked
with med
music.
Heiser, 1997 Outpt 34 60 minutes X X X X X
surgical choice of 3
PACU tapes
Chlan, 1998 Mech 54 30 minutes of ** ** **
ventilated music no
pts lyrics
60-80 bpm
Broscious, 1999 Cardiac 156 Music begun 10 X X X No differ in
surgery min prior to med use
proc Pt enjoyed
Good, Stanton- Abdominal 500 synthesizer, X Relax, music
Hicks, Grass, surgical harp, piano, and relax
Anderson, Choi, patients orchestral or w/music all
Schoolmeesters, & slow jazz. decreased
Salaman, 1999 pain, but
mus/relax
greater effects
day 1 postop
Cadigan, 2001 cardiac 140 30 minutes X ** ** X **
patients on
bed rest
Good, Anderson, Post-op gyn 311 Used jazz, ** Relax, music
Stanton-Hicks, patients classical, piano, and relax
Grass & Makii, synthesizer and w/music all
2002 harp music decreased pain
played 60 compared to
minutes control
continuously
post-op
Lewin, Thompson, Acute MI 243 opera, classical, X To listen at
& Elton 2002 randomi folk pop and least once in
zed to rock music 12 hrs but as
MT or chosen from often as
ART box vs. desired
advice/relax
tape
 10

Table 1, continued
Authors Pt Sample Independent Dependent Addl
Popul Size Variables Variables D var/
** Sig results X not measured Comments
HR RR BP Ox Anx Pain Mood
Yung, Chui-Kam, TURP 30 Choice of 3 X ** ** Included a
French, & Chan, surgical different slow, nurse
2002 patients soft music tapes presence
via headphones group
Bally, Campbell, Coronary 107 Pt selected X X X X Pts
Chesnick, & angio- cassette via appreciated ,
Tranmer 2003 graphy headphones chose from
before, during classical, soft
About 45 and after rock, easy
min procedure listen, country
procedure
Kwekkeboom, Cancer 60 CD of pt. X X Music,
2003 patients preference from distraction &
undergoing researcher tx as usual
noxious tx collection equal
Phumdoung & Women in 110 3 hours of soft **
Good, 2003 active labor instrumental
music
Chafin, Roy, Geren Undergrad 75 Performed task ** Compared to
& Christenfeld, students then listened to 10 minutes of
2004 10 minutes of rest
music Classical most
(classical, jazz effective in
or pop) dec BP
Ikonomidou outpt 60 X X ** Less use of
2004 Surgical pts pain meds
Pre and
post op
Lee, Henderson & Same day 113 Western-style X X X **
Schum, 2004 surgery easy listening
and Chinese
pop. All chose
Chinese
Voss, Good, Yates, Open heart 61 30 minutes ** ** Scripted
et al 2004 surgical chosen from 6 presentation,
offerings, Music more
effective than
rest or tx as
usual
Lee, Chung, Chan Mech vent 64 30 minutes ** ** ** X
& Chan 2005 from researcher
collection
Nilsson, Rawal, Outpatient 182 Music soft X ** X ** Music
Enqvist, & surgical classical continuous
Unosson 2003 w/no Music from arrival
premed w/suggestion, @ PACU until
using relax, calm in pt. requested
general literature stop
anesthesia w/male voice
Thorgaard, Cardiac 193 Preplanned 82% found
Henriksen, Cath Lab sequence of music pleasant
Pedersbaek, & patients classical & spec emphasis on
Thomsen 2004 composed environ

Thorgaard, PACU 267 Designed sound 83% found it

Ertmann, Hansen, units environment pleasant, 6%
& Noerregaard, patients found it
2004 unpleasant
11% no
opinion
 11

Table 1, continued
Authors Pt Sample Independent Dependent Addl
Popul Size Variables Variables D var /
** Sig results X not measured Comments
HR RR BP Ox Anx Pain Mood
Nilsson, Outpt 75 43 min of 7 X X X ** ** Less morphine
Unosson & surgical melodies use, no dec in
Rawal 2005 played for up IgA or Blood
to 2 hr. glucose
Chan, Wong, Chan ICU 43 45 minutes, no ** ** ** ** **
2006 lyrics, slow soft
Sendelbach, Halm, cardiac 86 20 min music X X ** ** No difference
Doran, Miller, & surg pts vs. 20 m rest in medication
Gaillard CABG & use
2006 valvular
Twiss, Seaver, & CABG & 60 Prescriptive ** Intubation
McCaffrey valvular Music CDs time sig
2006 surg over 6 choices
age 65
Chlan, Engeland, Vent pts 10 60 min pref X Biomarkers of
Anthony, chosen from stress X
Guttormson easy list, class, All S chose
2007 country, new classical
age music
Philips ICU 40 25 minutes X X X Rapid Shallow
2007 20 card preferred songs Breathing
surg entrained to Index **
20 medical breathing rate at
Vent pts weaning
@ weaning
Schwartz CABG pts 67 Light piano Time in ICU
2009 music vs. no decreased
music Costs nor
Time to
extubation
decreased

The impetus for this study arose from the authors years of experience working

with medical patients in a community hospital. In this work, she assessed patients

receiving intensive care and decided which patients would receive music therapy or

music listening alone without a music therapist present; this decision depended upon the

identified needs of the patient and the caseload of the therapist. For the latter, music

listening materials were delivered to the nursing unit with their use monitored and

encouraged by nursing unit staff. Her observations revealed that those who had sessions

with a music therapist reported greater benefits from the music experience. This

anecdotal evidence is the foundation for the authors interest in making an objective
 12

comparison under more controlled conditions. Specifically, there is an interest in

understanding if the benefits to patients of music listening vs. music therapy are

reproducible and statistically significant. In addition, can data comparing the effects of

music therapy and music listening provide a foundation for research that will lead to

clinical pathways (protocols) for music therapy in the ICU? In the next chapter, related

literature will provide rationale for the study.

 13

CHAPTER 2

Review of Literature

The stressors of treatment in ICU are well documented in medical literature, and

there are multiple approaches to address these stressors. Beginning with an overview of

the sources of stress and its negative effects on health, the use of music or music therapy

as a means to alter physiological and psychological parameters of stress is addressed.

Understanding Stress in Intensive Care Treatment

ICU Cost Factors

Medical treatment in intensive care units has been increasing over the past two

decades. Intensive care is provided for more than 4 million U.S. patients annually,

costing over $180 billion (Halpern, Bettes & Greenstein, 1994); the annual national cost

has not been reported since 1994 (Halpern, Pastores, & Greinstein, 2004). The costs

associated with intensive care represent the largest consumption of financial resources in

the hospital (Dasta, McLaughlin, Mody, & Piech, 2005).

Although the number of beds and the length of stay for many non-critical care

patients has decreased as a way to contain healthcare costs, those receiving acute hospital

care have higher levels of medical need and require more medical attention. As a result,

the total number of non-critical hospital beds has decreased by 8.9 %, whereas the portion

of beds allocated to intensive care has increased by 26.2 % (Halpern, et al., 2004). This

increase is related to the medical needs of the aging population, i.e., the baby boomer

generation, as well as to improvements in disease management (Leapfrog Group, 2008).

 14

The provision of critical care is considered to be a major factor in healthcare quality

assurance, and the wider use of critical-care physicians is associated with improved

patient outcomes (Halpern, et al., 1994). The need for critical care services allows

patients to survive who might not survive without it; however, it is accompanied by

multiple physiological and psychological stressors (Chan, et al., 2008).

Prevalence and Causes of Stress in the ICU

It is widely accepted that admission to an ICU is fraught with patient distress and

discomfort. Linked both to the critical condition of the patient and to the multiple

stressors of the environment, ICU stress is a major clinical problem (Cochran & Ganong,

1989; Cornock, 1998; Lower, Bonsack & Gulon, 2002; Mayou & Smith, 1997; Perrins, et

al., 1998, Pisani, Kong, Kasl, Murphy, Araujo, & Van Ness, 2009; Scragg, Jones, &

Fauvel, 2001).

The medical crisis which precipitates admission to ICU creates additional

physiological risk or stressors. These stressors include elevated blood glucose (Capes,

Hunt, Malmberg, & Gerstein, 2000), hyperlactatemia or an excess of ester or salt from

lactate (Galas, Haijan, Simones, Vieira, Filho, & Auler., 2009; Khosravani, Shahpori,

Stelfox, Kirkpatrick, & Laupland, 2009), hyponatremia, a low blood sodium level

(Cucchiara, et al., 2004; Mokhtari, Kouchek, Miri, & Goharani, 2009), hypernatremia, an

elevated blood sodium level (Lindner, et al., 2007; Polderman, Schreuder, van Schijndel,

Strack & Thijs, 1999), or a decrease in blood pressure (Green, Hutton, McIntyre, &

Fergusson, 2009).
 15

Stress in the ICU impacts both physical and psychological well-being (Lee, et al.,

2005). The occurrence of stress and anxiety for intensive care unit (ICU) patients is so

prevalent that a survey of 748 critical care nurses identified anxiety as a major clinical

concern and rated the need for anxiety management 4.8 on a scale of 1-5 (5 as high)

(Fraizer, et al., 2003). Research in the ICU has enumerated multiple causes of stress

ranging from environmental factors to medical errors.

A significant stressor for patients receiving intensive care is pain (Dracup &

Bryan-Brown, 1995; Hall-Lord, Larsson, Bostrom, 1994; Magarey & McCutcheon, 2005;

Murray, 1990; Novaes, et al., 1997; Novaes, et al., 1999; Rotondi, et al., 2002; Turner,

Briggs, Springhorn & Potgieter, 1990). Pain as a stressor can have a negative effect on

the patients recovery (Dracup & Bryan-Brown, 1995; Kaiser, 1992; Puntillo & Weiss,

1994) and has been linked to pulmonary complications and increased physiological stress

on the heart (Pooler-Lunse & Price, 1992). Critically ill patients may suffer

disproportionately compared with other hospitalized patients. Significant pain is common

for critically ill patients arising from life-threatening illness or injury, or pain associated

with simple procedures, such as removal of a chest tube (Kinney, Kirchhoff, & Puntillo,

1995). Furthermore, pain contributes to other physiological stressors including

hypertension, increases in stress hormones and tachycardia (Hamill-Ruth, 2002). In

contrast, the appropriate management of pain has been associated with improved

outcomes (Chanques, Jaber, Barbotte, Violet, & Sebbane, 2006).

Disturbed or interrupted sleep appears in multiple studies as a significant stressor

for ICU patients (Cornock, 1998; Gabor, 2003; Novaes, et al., 1997; Novaes, et al., 1999;
 16

Parthasarathy & Tobin, 2004) and was recalled as the second most bothersome

experience in a study of patients memories of ICU (Rotondi, et al., 2002). Poor sleep

quality has a profound effect on health as it compromises immune, metabolic, and

neuroendocrine function, increases mortality risk (Carmichael & Reis, 2005) and has

been documented to have residual effects after hospital discharge (Pilcher and Huffcut,

1999). Because of the ICU noise levels, the constant light and the need for care, patients

sleep patterns are often disrupted. In a study of 50 ICU patients, the inability to sleep

ranked as the second greatest stressor, with only pain ranking higher. In addition, pain

coupled with tubes contributes to difficulty with sleep (Novaes, et al., 1999). In a meta-

analysis of sleep studies done with ICU patients, Parthasarathy & Tobin (2004) identified

three major sleep issues. First, noise and staff activity are responsible for 11-20% of

arousals and awakenings; the second problem is mechanical ventilation, experienced by

40% of ICU patients, resulting in between 20-63 arousals and awakenings in one hour.

The third sleep issue is a constellation of factors including pain, light and acuity of illness

which often disrupt sleep. Follow-up interviews with patients six months after discharge

from ICU suggest that sleep disturbance lingers after patients leave the hospital. Further,

the lack of sleep has been associated with sympathetic arousal, a decrease in immune

function, and mood and cognitive disturbances in normal individuals (Irwin, Clark,

Kennedy, Gillin, & Ziegler, 2003). Sleep disturbance thus has even greater implications

for those with critical medical conditions as regular sleep patterns have been associated

with better outcomes (Valente, et al., 2002).

 17

The presence of tubes in the mouth or nose causes additional distress, and this

contributes to feelings of being tied down for some patients (Novaes, et al., 1997).

Furthermore, it contributes to the inability of patients to communicate, another significant

stressor for ICU patients (Granberg, Engberg, & Lundberg, 1998; Hafsteindottir, 1996;

Simpson, Armstrong, & Mitchell, 1989). The inability to speak to communicate was

even more bothersome than pain to some patients who reported their memories of the

ICU experience (Rotondi, et al., 2002).

Mechanical ventilation, a common reason for ICU care, requires the use of

endotracheal tubes which prevent the patient from speaking. This barrier to

communication can be very distressing and negatively impact recovery (Menzell, 1998).

In addition to interfering with speech, the endotracheal tube is also associated with pain,

with a feeling of choking or not getting enough air and with disturbed sleep (Cornock,

1998; Rotondi, et al., 2002). Adequate pain management is associated with a shorter

duration of mechanical ventilation and lower nosocomial (hospital-acquired) infection

rates (Chanques, et al., 2006). Emergency intubation in the intensive care unit is

associated with significant and life-threatening complications in about 30% of cases

(Jaber, et al., 2006). In addition to the risks associated with intubation, problems with

unplanned dislodgement or inappropriate disconnection of lines, catheters, and drains are

the most prevalent adverse or sentinel events in intensive care units (Valentin, et al.,

2006). These line, tub and drain problems have been associated with severe

complications and extended lengths of stay in the ICU (Needham, et al., 2005).
 18

The environment of the ICU, with its machinery, flashing lights, alarms and loud

noises, unfamiliar smells, and lights on 24 hours a day, coupled with patients

experiences of invasive procedures, lack of privacy, separation from family, and

immobility contribute to making ICU care a stressful experience (Godfrey, Parten, &

Buckner, 2006; Gowan, 1979; Harris, 1984; Kleck, 1984; Noble, 1982). Noise has been

identified as a key stressor in the ICU as it disrupts the patients ability to rest and

recuperate (Cochran & Ganong, 1989; Cornock, 1998; Green, 1996; Lower, et al., 2002;

Monsen & Edell-Gustafsson, 2005; Novaes, et al., 1997; Simini, 1999; Topf, 2000). For

patients receiving critical care, the lack of understanding of what is happening and the

sense of having no control adds to the stress (Novaes, et al., 1997). Anxiety, which

accompanies the experience of this environment, can lead to agitation, delirium, and

other complications (Nasraway, 2001).

It is not unusual for patients in ICU to receive routine infusions of sedative drugs

to decrease their anxiety and agitation, both of which can interfere with treatment and

recovery. The ongoing use of sedatives facilitates care and reduces the discomfort of

procedures, dressing changes and suctioning (Nasraway, 2001). Deciding which sedative

drugs to use is complicated and linked to the individual patients diagnosis, previous

exposure to these drugs (Park, Lane, Rogers, & Bassett, 2007) and their potential side

effects (Darrouj, Karma, & Arora, 2009). Bourne (2008) suggests that it is imperative

for intensive care unit staff to be aware of delirium that may result from the use of these

drugs and be prepared to reduce medication and implement non-pharmacological

interventions.
 19

Psychological Impact

Also of concern for ICU patients is the psychological impact of the intensive care

unit experience. Some authors view the psychological changes experienced by ICU

patients as transient responses to stress resulting from the immediate realities of the

treatment environment and the necessary medical care (Kleck, 1984; Novaes, et.al.,

1999). These stressors can sometimes lead to a state of delirium that is often referred to

as ICU psychosis. Kleck (1984) estimates that some symptoms of this syndrome will

occur in 20-30% of patients who remain in ICU for more than 5-7 days.

In addition to the ICU psychosis response, anxiety and depression are common

responses to ICU treatment (Li & Puntillo, 2006; Scragg, Jones, & Fauvel, 2001). In a

study of symptoms in ICU, Sukantarat, Williamson, & Brett (2007) noted that about 25%

of those who survive a 3-day or more stay in ICU will have symptoms of anxiety and/or

depression that may last up to 9 months following discharge. These psychological

responses to ICU treatment can not only interfere with the patients response to treatment,

but also may impact the patients quality of life for months after discharge from the

hospital. Addressing these psychological needs of ICU patients can decrease stress and

the long term consequences of these stressors (Godfrey, et al., 2006; Hupcey, 2004).

Adverse Outcomes

The prevalence of adverse outcomes also presents significant concerns, as these

events add to the physiological and psychological stress of receiving ICU care. Baker, et

al. (2004) defines an adverse event as an unintended injury or complication caused by the

delivery of clinical care rather than by the patients underlying condition. Adverse
 20

outcomes occur in up to 39% of patients receiving critical care (Orgeas, et al., 2008), and

nearly 25% of those who experience one adverse outcome will experience a second.

Rates also increase for patients who experience organ failure, a higher intensity level of

care or a longer length of stay in the ICU (Valentin, et al., 2006).

Medication errors have been found to account for 78% of serious adverse events

in intensive care units (Rothschild, et al., 2005). In addition, the risks inherent in the

continued use of sedative drugs (Shaffer, 1998) and resultant neurological problems are

common issues (Pandharipande, et al., 2006).

Nosocomial pneumonia occurs in 32-40% of patients receiving nutritional support

via gastro or jejunal tubes (Montejo, et al., 2002), and acute respiratory failure in

intensive care patients is associated with a higher mortality rate (Lee, et al., 2009).

Adverse events are responsible for a great deal of patient stress; these have the

potential to interfere with the patients response to treatment and impede recovery. The

consequences of adverse outcomes can lead to an extended length of stay in the ICU,

psychological trauma that impacts quality of life for months after treatment or most

seriously, death. Finding interventions that can decrease patients physiological and

psychological responses to stress resulting from adverse events can make a significant

contribution to the patients care.

An increasing body of knowledge demonstrates that psychological interventions

with those who have a major illness extends life expectancy and may affect positive

outcomes of treatments in life-threatening illnesses (Anbar & Murthy, 2010;

Cunningham, et.al, 2000). A review of literature examining psychosocial interventions

 21

for patients in intensive care supports the use of psychological interventions to improve

outcomes (Papathanassoglou, 2010). Music listening and music therapy are

psychosocial interventions that can impact on the stress response of patients in intensive

care.

Music Medicine for Stress Management

A review of music medicine and music therapy literature provides a basis for

understanding how music may be effective in ameliorating the stress related to illness and

hospitalization. Dileo (1999) defines music medicine as a non-pharmacological

intervention in which the patient listens to pre-recorded music preselected by medical

staff or selected by the patient from available programs. Music therapy refers to a

therapeutic process including a music therapist and a relationship developed through the

music experience and that therapeutic process.

A meta-analysis of medical music therapy was conducted on published and

unpublished studies from 1967 through 2003 (Dileo & Bradt, 2005). This analysis of 183

studies included 167 published; ten unpublished doctoral dissertations, five unpublished

masters theses and one unpublished paper. The 183 studies were divided into eleven

medical specialties, and 180 dependent variables were condensed into 40 categories of

variables for analysis. Of these studies, 143 revealed a positive sample level effect size.

The mean sample-based effect size for the medical category, Cardiology/ICU was r = .21

for non-preferred music and r = .36 for patient-preferred music. This category included

only fourteen studies, eight using randomization, two non-randomized, and four used

within-subjects designs (p 27). Important dependent variables for cardiology/ICU and

 22

surgical patients are listed in Table 2. Because all of the studies in this category were

classified as music medicine, the authors call for music therapy studies within this

category, so that effects of these two types of intervention can be compared (p. 62).
 23

Table 2
Effect Size for Cardiology/ICU Studies from Dileo and Bradts Meta-Analysis
(2005)
Variable Number of Number of Effect Size Significance
Studies Subjects Level
Heart Rate 12 606 r =.21 p =.00
Heart Rate 11 579 r =.13 p =.04
(outliers
removed)
Respiratory Rate 7 301 r =.50 p =.00
Respiratory Rate 5 274 r =.37 p =.00
(outliers
removed)
Diastolic Blood 8 475 r =.10 p =.04
Pressure
Systolic Blood 9 505 r =.12 p =.05
Pressure
Blood Pressure 1 20 r =.58
Oxygen 1 20 r =.26
Saturation
Pain 2 159 r =.35 p = .27
Anxiety (STAI) 8 413 r =.35 p = .00
Anxiety (non- 1 23 r =.79
STAI)
Sleep (surgical, 2 150 r =.30 p =.00
not
Cardiology/ICU)

Bradt and Dileo (2009) took a closer look at the use of music interventions for

patients with coronary heart disease. They included twenty-three trials with 1461

participants; most studies utilized music medicine, and only two included a trained music

therapist. A moderate effect was found for changes in anxiety scores in twelve studies

with myocardial infarction patients. Heart rate decreased for patients, with a larger

decline in studies using patient-selected music. Patient-selected music also resulted in

decreases in respiratory rate. Blood pressure readings were significantly lowered for

systolic readings whereas diastolic readings were lower but statistically significant. A
 24

small effect size was reported for declines in self-reported pain across studies that used

more than one music session.

A review of studies including mechanically ventilated patients (Bradt, Dileo &

Grocke, 2010) included eight studies, with 213 participants, addressing anxiety and

physiological measures of stress. Three studies addressed anxiety, and the pooled

estimate suggests that music therapy may have a beneficial effect on anxiety. The

authors also found a significant decrease in heart rate across five studies and a significant

effect on respiratory rate across six studies. This review, like the cardiac review, also

included music medicine studies.

Additional research published after the Dileo and Bradts meta-analysis (2005)

and the Cochrane Review is described in Table 3. Bradt and Dileo (2009) reported that

most of the studies in the Cardiac Cochrane Review used a single session with 30

minutes of music. Studies included in the table reveal a wide variance in length of music

session and number of sessions, and a wide variety of music selections. Most studies use

multiple music genres and allow the participant to choose from those presented. Authors

of the most recent studies consistently report significant changes in heart rate, blood

pressure, respiratory rate, pain and anxiety.

 25

Table 3
Music Medicine Research 2004 and beyond Cardiology/ICU and Surgical
specializations only
Author n Cardiac/ Diagnoses Design Measures Preference Independ Depend Type Music Significant
ICU or Group variable variable results
Surgical
Voss, Good, 61 Cardiac Cardiac Experi- Pre Post Yes from 30 Music Anx six types of Music grp
& Yates, surgery mental session collection listening (VAS) music sig less
Baun, (2) offered or rest vs. Pain synthesizer, anx, pain
Thompson, Control con sensation( harp, piano, sensation
Hertzog VAS) orchestra, and pain
2004 Pain slow jazz, distress
distress and flute than rest or
(VAS) control

Krucoff, 748 Cardiac Cardiac RCT Follow up Yes, from Music, in-hosp. Easy 6 mo.
Crater, full Dble data at 6 specific imagery major listening death
Gallup, data blind months offerings and touch adverse classical or lower in
Blankenship for post with or cardiovas country MIT pts
Cuffe, & 717 session without events and 6 mo.
Guaneri, et prayer 6-month death rates
al. 2005 40 touch, readm or lower in
imagery death prayer &
to music MIT group
No Sig
Lee, Chung, 64 Cardiac ICU Experi- Physio- Yes 30 music Anxiety No details HR RR BP
Chan, & Mech mental logical from via (C-STAI) given sig diff
Chan. Vent Control measure collection earphones HR, BP, when pre-
2005 pre/post or rest RR post
session changes
btwn grps
Tse, Chan & 57 Surgical Post op Experi- Vitals Yes Music HR, BP Chinese or Sig dec in
Benzie mental along with played Pain Western of pain for
2005 Control VAS scale inter- Pain med various music grp,
for pain mittently use types or lower SBP
for first own music and HR,
24 hrs from home less pain
post op meds
30 post
op, q 4
hrs, day 1
post op @
8A and
12n
Chan, Wong, 43 Cardiac/ ICU pts Experi- Baseline, Yes, from Music HR, RR, slow Significant
Chan, et al ICU for mental 15, 30, 45 three styles during 45 Oxy rhythmic changes in
2006 C-Clamp control minutes offered min proc Pain songs, HR, RR,
proc played via Chinese Oxy at 45
earphones slow min over
on MP3 rhythmic, control
player and Western Pain sig
slow lower in
rhythmic music
music, no group
Lyrics No music
showed sig
inc in pain
at 45 min
Sendelbach 86 Cardiac/ Cardiac Experi- Pre post Yes from 20 music Anxiety Easy Sig diff in
Halm ICU surgery mental session offerings or 20 rest (STAI), listening, anx and
Doran, et al Control measures post op pain, HR, classical, pain
2006 day 1 & 3 BP, and and jazz.
opioid use
 26

Table 3, continued
Author n Cardiac/ Diagnoses Design Measures Preference Independ Depend Type Music Significant
ICU or Group variable variable results
Surgical
Twiss, 65 Surgical Cardiac Experi Post anx Yes from Music STAI pre Clarity: Music grp
Seaver & > surgery mental & six CD during op and 3 movie sig lower
McCaffrey 65 Control Intubation from and after days post melodies STAI and
2006 y time Prescriptiv surgery op; (19) sig less
e Music Timeless intub time
originals( 2)
Towards:
piano
Improv (4)
Interlude:
Mozart
piano (5)
Universe:
synth
composition
(0) Essence:
orig & trad
comp on
cello and
piano (0)

Buffum, 170 Cardiac Vascular Experi Pre and Yes from 15 of Anx classical, Sig dec in
Sasso, & /ICU angio mental post music choices music (STAI) jazz, rock, HR & anx
Sands, et al. Control listening before HR, BP, country for music
2006 or 15 rest procedure RR western, and grp vs.
easy control
listening
McCaffrey 124 Surgical Knee & Experi Retro- Yes, from Music Pain Pop, Big Sig dec in
& Locsin hip mental spective selections played Ambu- Band, pain med
2006 surgery Control chart offered - auto- lation Classical, use; diff
pts review wide matically Medi- New Age, in self
and variety 4 X/day cations reprt of
follow-up for 1 hr. pain for
phone call music grp;
10 days sig fewer
post d/c periods of
acute
confusion
Chlan, 10 Cardiac ICU mech Experi measured Yes, from Classical Cortico- classical, No
Engeland, & /ICU vent mental 4 times types music (all trophin, new age, significant
Anthony, et Control during the offered chose) for cortisol, easy diff
al. 60 60 60 via epineph- listening,
2007 music minutes. earphones rine, nor country
or 60 epineph-
rest rine
Ebneshahidi 80 Surgical Cesarean RCT VAS pain Yes 30 music Pain Brought Sig dec
& Mohseni section Med via head- Anxiety favorite pain and
2008 docum phones in Opioid music opioid use
Pre Post recovery use
BP, HR
Allred, Byers 56 Surgical Surgical Experi- VAS pain Experi- 20 of Pain, easy No sig diff
& Sole, 2010 knee mental and mental music via anxiety, listening btwn grps
replace- re- anxiety, (music) and head- affect, (six for pain
ment peated MPQ, rest phones vs. mean different and anx
meas. vital signs (control) rest period arterial CDs for Within
monitor group before 1st pressure, participants groups
Pre and post-op heart rate, to choose significant
Post PT respirator from) decrease in
session y rate, ox pain over
saturation time
 27

Table 3, continued
Author n Cardiac/ Diagnoses Design Measures Preference Independ Depend Type Music Significant
ICU or Group variable variable results
Surgical
Moradipanah 74 Cardiac Coronary RCT De- No 20 music Anxiety Classical Sig dec in
Mohammadi /ICU angio- pression vs. 20 (STAI), and mean
& graphy Anxiety rest for Stress, movie/pop scores of
Mohammadi procedure Stress control De- music (3 state
2009 Scale pression selections) anxiety (P
Pre-post at 70/80 = 0.006),
test bpm stress (P =
0.001) and
depression
P = 0.02)
in the
interven-
tion group
Nilsson 2009 58 Surgical CABG or RCT Blood Yes Music Cortisol Sig dec in
aortic gases pillow HR cortisol for
value Monitors RR music grp
replcmnt Numeric MAP Ox
Rating Sat Pain
Scale for Anx
pain /anx
Pre, Post
and 30
post
Schwartz 67 Cardiac CABG in Experi- Med Rec Not Post op Time in Light piano Sig dec in
2009 /ICU ICU post mental & initially, as via head- ICU music time in
op Control Financial awake phones in Time to ICU
rec could ICU extub Costs nor
Length choose Cost of Time to
listen care extub were
Time on decreased
vent
Total
costs
ICU,
Resp,
Pharmacy
Cooke, 17 Post-op Planned Single Pre 15 Yes 15 of Anx Own CD or No sig
Chaboyer, ICU surg blind Post music via Dis- Classical difference
Schluter, w/ICU random session head- comfort Jazz CW
Foster, stay Cross- each N 2 phones in New age
Harris, proc - over sessions ICU Easy list
Teakle, 2010 turning Contemp
Dijkstra, 20 Cardiac/ Mech vent RCT Nurse Yes 30 music MAP Classical or Sig btwn
Gamel, van ICU recorded X 3 over 2 SBP film music grp
der Bijl, Bits, baseline days via DBP DBP &
Kesecioglu and post head- HR HR over
2010 each phones RR time
music Sedation Sedation
session score
lower on
first
measure
Han, Li, Sit, 137 Cardiac/ Mech vent RCT Pre Post Yes Music ANX 40 CDs Sig dec
Chung, Jiao, ICU HR,RR, Placebo HR Classical Anx, HR,
MA Ox at 5 control RR Easy list SBP, DBP
2010 intervals SBP Trad RR sig
DBP Chinese lower
Ox Sat folk however
Familiar sig diff @
artists baseline
 28

Table 3, continued
Author n Cardiac/ Diagnoses Design Measures Preference Independ Depend Type Music Significant
ICU or Group variable variable results
Surgical
Binns- 30 Surgical Breast Ca RCT Pre Post Yes Pre-intra- MAP Classical Sig dec
Turner, SAI post- FR Easy list MAP,
Wilson, VAS pain operative ANX Inspirational ANX
Pryor, Boyd, music Pain New Age Pain
Prickett CD 4 hrs
2011
Lin, Lin, 60 Surgical Spine Experi- VAS pain Yes Two pre- Anx Classical Sig dif in
Huang, Hsu, mental STAI op & two Pain Chinese Pop Anx, pain,
Lin 2011 & Vitals post-op HR Nature MAP
Control monitor 30 music BP Sacred
sessions MAP
Cortisol
Korhan, 60 Cardiac/ Mech Experi- Pre-Intra- No 60 music SBP Classical Sig dec in
Khorshid, ICU Vent mental Post, Post via head- DBP Bach on RR, SBP,
Uyar, 2011 & 30 phones RR flute DBP inc
Control MP3 HR over time
Ox Sat
Vaajoki, 168 Surgical Ab- Experi- Pretest Yes 25 music SBP 2000 songs Sig diff in
Kankkunaen, dominal mental Posttest post-op X DBP in Pop SBP and
Pietila , surgeries Control 8 via MP3 HR dance rock RR
Vehvilainen- w/head- RR soul blues
Julkunen phones spiritual
2011 classical
Jafari, 60 Surgical Open Experi- Pre Post Yes 30 via Pain from Sig dec in
Xeydi, Heart mental Post 30 head- relaxing pain
Khani, & & 60 phones music
Ermaeili, Control NRS pain MP3 selected by
Soleimani experts
2012

The data from the Dileo and Bradt (2005) meta-analysis, the Cochrane Review of

music for coronary heart disease patients (Bradt & Dileo, 2009) and the Cochrane

Review of music for mechanically ventilated patients (Bradt Dileo & Grocke, 2010)

provide a more in-depth understanding of how music medicine and music therapy have

been shown to impact the dependent variables for this study.

Music and Heart Rate

Music medicine was found to have a moderate effect size (r = .24) in sixteen

surgical studies and twelve Cardiology/ICU studies included in the Dileo and Bradt meta-

analysis (2005). The surgical patients who listened to preferred music had lower heart

rates (r = .32) than those who listened to researcher-selected music (r = .02). Similarly,
 29

the effects on heart rate for cardiology/ICU patients who listened to preferred music (r

= .21), while not statistically significant, were larger than the effect size for those

cardiology/ICU patients who listened to researcher-selected music (r = .05). The studies

in both categories were heterogeneous even after removing outliers from the

cardiology/ICU group. The Cardiac Cochrane Review (Bradt & Dileo, 2009) included

fourteen heterogeneous studies and revealed a significant effect of music on heart rate

with inconsistent results across the studies. Bradt, Dileo & Grocke (2010) reported a

significant effect of music on heart rate across five studies in the Mechanical Ventilation

Cochrane Review.

Music and Blood Pressure

Music medicine studies have demonstrated that listening to pre-recorded music

affects systolic and diastolic blood pressure. In some studies, blood pressure is reported

as only one variable (Aragon, et al., 2002; Bally, Campbell, Chesnick, & Tranmer 2003;

Chan, et al., 2006; Lee, Henderson & Shum, 2004; Lee, et al., 2005), whereas in others,

systolic and diastolic measures are reported separately (Chafin, Roy, Gerin, &

Christenfeld, 2004). Dileo and Bradt (2005) in a meta-analysis of music medicine studies

reported a small effect size for blood pressure (r = .17) which was not statistically

significant based on the fourteen cardiology/ICU studies. Mean arterial pressure reported

for only one Cardiac/ICU study and three surgical studies had a large effect size (r = .74)

which was statistically significant. Twelve studies included in the Cardiac Cochrane

Review (Bradt & Dileo, 2009) demonstrated a significant effect on systolic blood

pressure with consistent results across studies, but not a significant effect on diastolic
 30

blood pressure. Eliminating one study from the diastolic blood pressure group did result

in homogeneous data and a statistically significant effect size. The Mechanical

Ventilation Cochrane Review (Bradt, Dileo & Grocke, 2010) reported significant results

for systolic, diastolic or mean arterial blood pressure.

Music and Respiration Rate

In music medicine studies with cardiology/ICU patients reported in the meta-

analysis (Dileo & Bradt, 2005), data for respiratory rate was found to have a medium

effect size. The number of studies measuring respiratory rate was limited (six surgical

and five cardiology/ICU), and the effect size is associated with significant heterogeneity,

so results must be interpreted with caution. Five Cardiac Cochrane Review studies

resulted in a significant change in respiratory rate for patients receiving music treatment

vs. standard care (Bradt & Dileo, 2009). Six studies in the Mechanical Ventilation

Cochrane Review (Bradt, Dileo & Grocke, 2010) demonstrated a significant effect on

respiratory rate which was consistent across studies.

Music and Oxygen Saturation

The Dileo and Bradt (2005) meta-analysis included only one cardiology/ICU

study with results for oxygen saturation with an effect size of .2. This one study

included only twenty participants, thus results must be interpreted with caution. The

Cardiac Cochrane Review (Bradt & Dileo, 2005) did not address oxygen saturation, and

the Mechanical Ventilation Cochrane Review (Bradt, Dileo & Grocke, 2010) included

only two studies with oxygen saturation measure which were not significant.
 31

Music and Pain Management

Results of the studies included in the Dileo and Bradt (2005) meta-analysis revealed

inconsistencies across population groups. Twenty-two music medicine studies with

surgical patients resulted in a small effect size (r = .15) of this intervention on pain. The

Cardiac Cochrane Review revealed a statistically significant difference in pain measures

between music and standard care (Bradt & Dileo, 2009) favoring music interventions as

more effective. The Mechanical Ventilation Cochrane Review (Bradt, Dileo & Grocke,

2010) did not include pain management as a measure.

Music and Anxiety Management

In the meta-analysis (Dileo & Bradt, 2005) anxiety reduction was found to have a

moderate effect size for both surgical patients and cardiology/ICU patient following

music listening. Smaller effects were found for those studies using the State-Trait

Anxiety Inventory as the specified measure (surgical r = .31 and Cardiology/ICU r = .35),

whereas the use of other measures of anxiety resulted in a larger effect size (however,

these studies were limited in number). This difference in results may be related to

research design. In the Cardiac Cochrane Review, Bradt & Dileo (2009) pooled those

studies using STAI State Anxiety form (STAI-S) and found a significantly lower anxiety

state for those receiving music. This STAI is a widely accepted, standardized measure of

state anxiety. STAI results reported for three studies in the Mechanic Ventilation

Cochrane Review (Bradt, Dileo & Grocke, 2010) also suggest that music interventions

may have a beneficial effect on anxiety for these patients.

 32

Music and Length of Stay in ICU

Data for length of stay are sparse. In the 2005 meta-analysis Dileo and Bradt

found no statistically significant results were found using three available surgical studies.

No cardiology/ICU studies were included. In a recent study, Schwartz (2009) included a

measure of length of time in ICU, identifying a significant decrease in length of stay for

patients receiving music medicine.

Music Therapy Studies

In Dileo and Bradts meta-analysis (2005) and the Cardiac Cochrane Review

(2009), there were only a limited number of music therapy studies. Separate data were

analyzed for some subsections of the meta-analysis, but the Cardiac Cochrane Review

included only two music therapy studies and the Mechanical Ventilation Cochrane

Review only one music therapy study, thus no separate analysis was completed.

Music Therapy and Heart Rate

Only four studies measuring heart rate used music therapy interventions across

populations in Dileo and Bradts meta-analysis (2005), with one study in the surgical

category and none in the Cardiology/ICU category. The impact of music therapy on

heart rate is not clear in this meta-analysis. Philips (2007) (using music therapy

interventions and included in the Mechanical Ventilation Cochrane Review) reported no

significant difference in heart rate between experimental and control groups.

 33

Music Therapy and Blood Pressure

Dileo and Bradt (2005) included two studies that examined the effects of music

therapy interventions on blood pressure. One focused on systolic blood pressure and the

other on blood pressure as a composite score (mean arterial pressure). Neither the

Cardiac Cochrane Review nor Mechanical Ventilation Cochrane Review included

enough data from music therapy studies to provide additional information.

Music Therapy and Respiration Rate

Three surgical music therapy studies included in the Dileo and Bradt (2005) meta-

analysis revealed small, significant, homogeneous effect sizes. No cardiology/ICU

studies were included. Philips (2007) data were included in the Mechanical Ventilation

Cochrane Review, but did not contribute significance to the results; when removed from

the music medicine studies there was little effect on the results.

Music Therapy and Oxygen Saturation

The Dileo and Bradt meta-analysis (2005) included only one study employing

music therapy interventions and measuring oxygen saturation. This study had only 20

participants. The Cardiac Cochrane Review (Bradt & Dileo, 2009) included no music

therapy studies measuring oxygen saturation, and the Mechanical Ventilation Cochrane

Review (Bradt, Dileo & Grocke, 2010) did not analyze its one music therapy study.

Music Therapy and Pain Management

Five music therapy studies were included in Dileo and Bradts meta-analysis

(2005); two of these studies were randomized, controlled trials. These two randomized

studies had a pooled large effect size (r = .74), however, these studies were not conducted
 34

with cardiology/ICU or surgical patients. Pain was not included as an outcome in any of

the recent music therapy studies or the Cardiac Cochrane Review (Bradt & Dileo, 2009)

or the Mechanical Ventilation Cochrane Review (Bradt, Dileo & Grocke, 2010).

Music Therapy and Anxiety Management

In Dileo and Bradts meta-analysis (2005), music therapy outcomes (across

specializations) were assessed using the State-Trait Anxiety Inventory (two studies) as

well as non-STAI measures (four studies); meta-analytic results showed a large effect

size for the STAI anxiety measure (r = .50) and a moderate effect size for the non-STAI

anxiety measure (r = .30) for music therapy interventions. There were too few music

therapy studies in both the Cardiac Cochrane Review and the Mechanical Ventilation

Cochrane Review to determine any effects of music therapy on anxiety.

Music Therapy and Length of Stay in ICU

No data related to length of stay was included in Dileo and Bradts meta-analysis

(2005) or in either Cochrane Review (Bradt & Dileo, 2009; Bradt, Dileo & Grocke,

2010). Length of stay was measured in one music therapy study conducted with patients

undergoing brain surgery. No significant differences were found in length of stay

between experimental and control groups (Walworth, Rumana, Nguyen, & Jarred, 2008).

Rationale for Current Study

Studies examining the use of music therapy interventions with ICU patients are

scarce. The medical music therapy meta-analysis (Dileo & Bradt, 2005) included only

seventeen studies clearly identified as using music therapy interventions. The music

therapy studies were most plentiful in the Alzheimers and Rehabilitation specialties,
 35

whereas cardiology/ICU and surgical studies included no music therapy studies except

two music therapy studies with pre-operative patients, which are not applicable to

inpatient treatment. Research examining the impact of music therapy interventions on

the physiological and psychological responses of medical patients, and in particular ICU

patients, are urgently needed. Dileo and Bradt (2005) offer an agenda for future research

in which they call for carefully designed research comparing music therapy with music

medicine and investigating music therapy interventions.

Few music therapy randomized controlled trials were found in the meta-analysis

or the Cochrane Reviews. Bradt and Dileo (2009) state, Randomized controlled trials

on the use of music therapy (provided by a trained music therapist) with this population

are urgently needed (p. 15). This strong statement of need provides a rationale for the

current study; a potentially useful contribution to medical and patient care and the

advancement of music therapy as a discipline.

Research Questions

The purpose of the present study was to compare the effects of a single session

of music therapy, or music medicine or attention control on physiological measures (heart

rate, mean blood pressure, oxygen saturation and respiratory rate), psychological

measures (anxiety and pain) associated with stress and length of stay for Intensive Care

Unit (ICU) patients.

Research questions posed were:

 36

Is there an effect of music therapy, music medicine or attention control on

physiological responses (heart rate, mean blood pressure, respiratory rate, and oxygen

saturation) of ICU patients? Is there a difference in effects among these interventions?

Is there an effect of music therapy, music medicine or attention control on anxiety

levels of ICU patients? Is there a difference in effects among these interventions?

Is there an effect of music therapy, music medicine or attention control on pain of

ICU patients? Is there a difference in effects among these interventions?

Is there an effect of music therapy, music medicine or attention control on length

of stay for patients in ICU? Is there a difference among these interventions?

Hypotheses for this study:

Music therapy interventions will result in significantly different medically

beneficial physiological changes in heart rate, mean blood pressure, respiratory rate, and

oxygen saturation than music medicine or attention control.

Music therapy interventions will result in a significantly larger decrease in anxiety

scores than changes resulting from music medicine or attention control.

Music therapy interventions will result in a significantly larger decrease in pain

scores than changes resulting from music medicine or attention control.

Music therapy interventions will result in shorter length of stay in the ICU than

music medicine or attention control.

 37

CHAPTER 3

RESEARCH METHOD

Participants

Participants were patients receiving treatment on an ICU of a general hospital. A

power analysis using a software calculator G*Power (Faul, Erdfelder, Lang & Buchner,

2007) indicated that for an expected moderate effect size (f = 0.25; p = 0.05) with power

of .80, a total of 159 participants was needed to conduct ANOVA analysis (Faul, et al.,

2007). The initial plan to recruit 175 participants was to allow for attrition. When

recruiting proved to be exceptionally difficult, the participant goal was abandoned and a

time limit was set to allow for data collection through the end of October, 2011.

The study was conducted with patients admitted to a closed ICU (defined as

having individual rooms within the unit) in a general community hospital. Patients are

admitted to this ICU for treatment of a variety of medical problems as well as short-term

monitoring following surgery.

Setting and Recruitment

This hospital is a 268-bed community hospital in a suburb east of Pittsburgh

where the researcher provided music therapy services for twenty years until 2001.

Participants were recruited from referrals made by ICU nursing staff on days when

research was possible. The researcher met with nursing staff to identify potential

participants and then approached each patient to explain the study and assess the patient's

alignment with study criteria. All potential participants received an explanation of the
 38

study and were asked to sign an Informed Consent form for participation, including

researcher access to medical records. This consent could be withdrawn at any time, and

choosing to withdraw from the study was explained to have no influence on the delivery

of medical care to the ICU patient (See Appendix B). Potential participants were told

that assignment to either research group or the attention control group was randomized

and could not be chosen or predicted. No potential participants who met criteria were

excluded.

Nursing staff assessed patients to determine if they met the study inclusion

criteria. Patients were eligible to participate in the study if they were medically stable,

conscious and alert; able to communicate using gestures, mouthing or speaking; had

adequate hearing to understand and hear music, spoke English and were between the ages

of 18 85 years.

Patients were excluded from the study if they were medically unstable, regardless

of length of stay in the ICU; experiencing any altered level of consciousness or dementia;

unable to communicate via verbal or nonverbal means; were non-English speaking; on

mechanical ventilation; had hearing difficulties, were younger than 18 years or older than

85 years or were seriously emotionally disturbed.

Procedure

Design

A randomized controlled trial with repeated measures design included a music

medicine group (MM), a music therapy group (MT) and an attention control group (AC).

The protocol for this research was reviewed and approved by the hospitals Institutional
 39

Review Board (IRB) and reviewed by Temple University IRB to permit the research to be

conducted.

Procedures for Study Approval

First, approval from the hospitals IRB was secured; the protocol was then

submitted to the IRB of Temple University for approval (see Appendix A). At the

hospital, this research had the support of a member of the medical staff from the ICU, a

cardio-thoracic surgeon who sees patients in the ICU daily, and the Hospital Office of

Supported Research.

Procedures for Random Assignment

After explaining the study and acquiring informed consent, participants were

assigned randomly to one of the three conditions (music medicine, music therapy or

attention control).

To control for bias, assignment to either intervention or control group required

that the researcher provide for randomization and adequate implementation of allocation

concealment (Beller, Gebski, & Keech, 2002). For this study, participants were assigned

to one of the three conditions based on a website randomizer used to assign 175 potential

participants to three groups (Urbaniak & Plous, 2008). From these groupings, two

hundred envelopes containing a group assignment were prepared by student research

assistants to prevent the researcher from knowing how many were in each group. The

researcher did not know to which condition the participant would be assigned until

opening the envelope.

 40

Procedures for Implementation

The researcher provided education sessions for unit staff to enlist their support

and assistance in maintaining the integrity of the research conditions. These sessions

were scheduled with the Unit Manager and made part of the usual monthly educational

programs for staff. One was held during the day shift (7 AM- 7PM) and one was held for

the evening shift (7 PM 7 AM). Staff members who attended were supportive and

interested in having music therapy services offered to their patients.

Research sessions were not scheduled during visiting hours unless the participant

was not expecting visitors. At the suggestion of the unit manager, research sessions were

usually held between 2 PM - 5 PM to avoid visiting time and to maximize the possibility

that participants were less likely to be involved in medical care, treatments or tests.

Original plans included a provision for sessions to be interrupted for medical care if

needed. The plan was to exclude any participant whose session was suspended for more

than 2 minutes. Fortunately this did not happen during any research sessions, and no one

was excluded because of need for medical care.

After assigning the participant to a group, the researcher discussed session time

preference with the participant. The therapist then consulted with the nurse caring for the

participant; the session was scheduled for the same day. This rapid involvement of the

participants in the study was necessary as patients moved in and out of ICU regularly,

some staying only a matter of hours. Because the ICU has set times for visiting, no

research sessions were conducted during those times unless scheduling at that time

reflected the participants preference or if the participant was not expecting visitors.
 41

Session Procedures

Music Medicine Group (MM)

The music medicine group members received a session of music in a passive

receptive mode averaging twenty-two minutes. Participants assigned to the MM group

were approached for music selection after completing pre-session data collection using a

script.

Music script. Hello, Im back with the music. I will help you choose music for

listening as a part of the research study. Before choosing music, I will play five

samples for you and you can choose the one that you prefer. If you need to hear

one or more a second time, I will play them for you. (Share examples with

participant who will make a choice; CD is placed in player and is set up.) The

participant is then instructed as follows: Now, I will turn on the music for you.

Lie back, relax and enjoy the music. You may want to close your eyes. Would

you like me to dim the lights? (Follow participant instruction). I will return when

the music is finished to retrieve the CD player and CD. (Turn on music and leave

the room, returning in 30 minutes to retrieve the music.)

The participant had the opportunity to choose from among five different styles of

music. The music choices were presented to the participant as samples including short

excerpts of the music on the five research CDs. These samples were presented in random

order to participants as they made their choice of CD. The researcher assisted the

participant, playing the samples more than once if needed. Once the participant selected

his or her preferred music, the researcher placed the CD into the player at the
 42

participants bedside, adjusted the volume and left the room, returning after 30 minutes to

retrieve the music. The researcher retrieved the music without engaging in any

discussion with the participant about the music, except to let the participant know that the

CD player was being removed. The researcher responded politely to participant-initiated

comments and recorded these after leaving the room.

Music Listening Selections

In order to study the effects of music medicine, it is necessary to utilize music that

has been demonstrated to be effective with ICU patients, either in research studies or

clinical practice. The music selections chosen for this study are presented in Table 4.

Traditional classical music was selected from Music for the Imagination (Bruscia, 1998);

a collection of CDs featuring classical music used for Bonny Method Guided Imagery

and Music. This music therapy method includes many pieces that are slow tempo with

few dynamic changes, thus making those selections useful for relaxation. Also included is

the music of Daniel Kobialka and Karen Follett (both of whom granted permission for the

use of his/her music as well as its re-recording to create a shortened version of the CDs).

Shortened versions of the CDs were needed to keep the music listening options within the

20-25 minute session length defined in the research design. The original music was

transferred to a Toshiba laptop computer, reordered and burned to a CD for use in the

study. Kobialkas music has also been used in research with patients in ICU and in

cardiac rehabilitation (Mandel, Hanser, Secic, & Davis, 2007). Kobialkas CDs are

characterized by the use of a variety of traditional orchestra instruments (violin, cello,

string bass, English horn, and flute) and world and folk instruments (Shakuhachi flute,
 43

Spanish guitar). The arrangements of the music use slower tempi than traditional

performance. In addition, portions of the CDs, Velvet Dreams and Rainbows were

included in the study, as this music was used previously with success by the researcher in

her clinical work with ICU patients. Because of the importance of spiritual support to

ICU patients (Koenig, 2004), a CD was recorded including familiar hymns from various

traditions. The researcher recruited an organist and choir members to sing and play the

music chosen from the public domain. The music was recorded on a handheld SONY

digital recorder, transferred to a laptop computer and edited using Audacity software.

This CD also included quiet organ music at the beginning and end of the collection of

songs. The music from Quiet Souls was created by composer and pianist Karen Follett

to be relaxing and was used previously by the researcher in clinical work.

 44

Table 4
Music programs used for music medicine intervention
CD Genre Music selections Composers Length Total
Time
Bruscia Traditional Christmas Oratorio Bach 5:55
Selections Classical Hummers Chorus Puccinni 2:46
from Music Swan of Tuonela Sibelius 8:50
for the Touch her soft lips Walton 1:50
Imagination and part
Capriol Suite (Pieds Warlock 2:20 21:41
en lair)
Kobialka New Age Sheep May Safely Bach 6:11
Rainbows Style Graze Mozart 9:11
traditional Sonata Rogers & 6:26
songs Oh, What A Hammerstein
Beautiful Morning 21:48
Kobialka New Age When You Wish Harline & 7:16
Relaxation Style Upon A Star Washington
arrangements Hush, Little Baby Scottish lullaby 4:27
of classical The Riddle Song Traditional 6:39
music The Future is Kobialka 4:39 23:01
Beautiful
Follett Solo Piano The Heart Shall Follett 6:44
Quiet Souls composed for Remain 6: 44
relaxation Yearning for Home 7:18
Of Sea- Adagio 20:02
Spiritual Organ and Organ Improvisation Lewis 2:25
Calvary traditional Ave Verum Byrd 3:48
Choir hymns What Wonderous Witherup 3:57
Love
Amazing Grace Newton 2:53
Near the Cross Crosby-Doane 3:34
Breathe On Me Hatch-Jackson 3:01
Breath of God
Abide with Me Bennett 2:47
Organ Improvisation Lewis 1:58 24:27

Music Therapy Group (MT)

The music therapy group received an individual session averaging 25 minutes conducted

by the researcher utilizing receptive, creative and/or re-creative music therapy techniques.
 45

Music therapy sessions were based on a protocol with pre-specified options/decision tree

for responding to the participants identified needs. The use of this protocol provided a

consistent approach to the music therapy process, but allowed the therapist to respond to

individual needs presented within the session. No script was developed for the session

but specific steps in the protocol were followed for each session.

Session protocol. The session used a decision tree which followed these steps:

1. Opening or Warm-up. Following the pre-session data collection,

the researcher talked with the participant about the use of music
for addressing physical and psychological needs, and asked the
participant to describe how he or she used music as a part of daily
life.
2. Song choice The participant was asked to choose a song that the
therapist sang or that the therapist and participant sang together. The
song was chosen with the aim of helping the participant feel more
comfortable Is there a song you would like to hear? (either from a list
provided or from the participants memory)
3. Verbal discussion of the participants response to the song led to
discussion of how participant was coping with the ICU/hospital
experience. Participant was asked if there was a song that reflected that
experience which was sung if known to the therapist or discussed by
the participant if not known.
4. Mobilizing coping skills (choice of one or two as clinically appropriate)
a. The participant was asked to choose a song that reflected feeling
stronger or healthier which was sung by the therapist and/or the
participant.
b. The therapist and participant together created an original song or song
parody to describe coping skills or something that made the participant
feel stronger or supported. This process involved brain storming ideas
about ways of coping, choosing a known melody to use for creating
lyrics, therapist and participant working together to create lyrics,
discussing fit and meaning as the lyrics unfolded. This new version
of a familiar song was then sung by the therapist and/or the participant.
c. Practice / learn relaxation technique (music assisted relaxation).
Participants were taught to use music-assisted relaxation (if not
familiar) or were given the opportunity to use known techniques with
verbal instruction/reminders from the therapist and live music on
either piano or guitar as requested by the participant.
 46

5. Closure The therapist and/or the participant sang a final song or the
therapist engaged the participant in a short relaxation exercise to remind
the participant of how and when to use the techniques independently.

The results of the pre-session Faces Anxiety Scale (FAS) and Visual Analog

Scale (VAS) provided the researcher with information to make decisions about how to

approach the opening of the music therapy session. Higher scores on the FAS and VAS

resulted in less verbal discussion in the opening portion of the session and a more rapid

introduction of music. Using the information from the demographic questionnaire, the

researcher offered and sang song options for participants experiencing high levels of

anxiety or pain. For those experiencing lower levels of anxiety or pain more discussion

was used to ascertain the participants relationship to music and to engage the participant

in decision-making to choose an opening song. The therapist had available song lists

(songs from the decades 1920-1980s, and a variety of genres including country, easy

listening, inspirational, patriotic, pop, musicals, jazz and rock) and a collection of CDs.

Following this song, the researcher decided if the participant could discuss the music (and

remain in the study) or if the participants needs required a deviation from the protocol.

If the participant was able to discuss the meaning of the music chosen and begin to share

his/her perception of the hospital stay, the protocol continued leading to either another

song chosen by the participant, a song chosen to use to create a parody with lyrics

focusing on ways to cope with the ICU experience or the use of music-assisted relaxation

techniques guided by the researcher. The session closed either with another song, a recap

of the song parody created in the session or with a final relaxation experience.
 47

Warm-up

Initial rapport building

followed by discussion
of musical preference

Participant chooses a
familiar song for
singing or listening

Discuss meaning of
chosen music to patient

Participant chooses a
song that reflects Therapist and participant Teach relaxation
feeling strong or create a song parody or techniques, deep
healthier which is original song describing breathing/breathe
played or sung available coping skills in music or
autogenic exercise
with music

Closure sing a
wrap-up song (or
repeat song reflecting
strength) or practice
relaxation exercise

Figure 1 Session Protocol

 48

Befriending/Attention Control Group (AC)

The attention control group received a visit from the researcher who sat with the

participant for an average of twenty-five minutes and engaged in conversation or sat in

silence as the participant desired. The researcher practiced a form of befriending using

reflective listening. Reflective listening employs specific techniques including repeating

or rephrasing, paraphrasing and reflection of feelings to feed back the participants

thoughts, assuring that the listener is hearing what is being communicated without adding

the listeners own ideas (National Health Care for the Homeless Council, nhchc.org).

Reflective listening does not include giving advice, asking probing questions or trying to

draw information out of the participant. Reflective listening is about hearing what the

participant is saying.

Befriending script. Good afternoon, Im back for our time together. I am here

to visit with you for the next 25 minutes. We can talk or I can just sit with you

and keep you company while you watch TV, rest or do anything else youd like.

I checked with your nurse and nothing is scheduled for this time, may I visit with

you now? (After the participant agrees to the visit, the researcher pulls a chair

next to the bed and sits.) Is there anything youd like to talk about, or would you

prefer to watch TV or rest? Whatever youd like to do is fine. (The participant

was given the opportunity to introduce any topic. The researcher offered

responses indicating active listening, but not information, advice or counsel. If

the participant desired, the researcher sat quietly and allowed the participant to

watch TV or sleep.)
 49

Measures

Dependent Variables

The dependent variables included physiological measures of stress response (heart

rate, mean arterial pressure, respiratory rate, and oxygen saturation) and psychological

measures of distress (anxiety and pain). Physiological data were collected from on-going

monitors used as part of routine hospital care in the intensive care unit. Pain was

measured using a Visual Analog Scale (VAS), and anxiety was measured using the Faces

Anxiety Scale (FAS).

The Faces Anxiety Scale (FAS) was chosen to measure anxiety as it is designed to

be used with more critically ill patients who have less tolerance for answering questions

required by many scales. The FAS is short and easy to complete, thus requiring little

energy expenditure from critically ill patients to gather relevant data. This scale was

found to elicit more responses than a Visual Analog Scale or the anxiety subscale of the

Brief Symptom Inventory with ICU patients (McKinley, Coote, & Stein-Parbury, 2003).

The FAS was found to have good internal consistency with the anxiety subscale of the

Hospital Anxiety and Depression Scale (HADS) (Gustad, Chaboyer & Wallace, 2005).

The FAS contains five faces drawn to express varying degrees of fear (based on the

success of the pediatric pain scale that uses faces to indicate severity of pain) (McKinley,

et al., 2003). The participant was instructed to point to the face that most nearly matches

how he/she is feeling at that moment (McKinley, et al., 2003). During development, this

scale was piloted with both medical patients and with college students and faculty to
 50

assure that the intervals between the faces accurately reflected the different degrees of

anxiety. There was a 95% agreement that the placement of the faces was representative

of a continuum of anxiety. Further study of the scale revealed correlation of 0.64

between ICU patient self-report on the FAS and a research assistants assessment based

on observation (McKinley, Stein-Parbury, Chehelnabi, & Lovas, 2004).

The Visual Analog Scale for Pain (VAS) was chosen because previous research

indicates that the reliability, validity and responsiveness of the VAS are high (Bolton &

Wilkonson, 1998; Guyatt, Townsend, Berman, & Keller, 1987; Jaeschke, Singer, &

Guyatt; 1990). Ohnhaus and Adler (1975) reported that the VAS measure of pain more

closely reflect what the patient actually experiences with these results supported by linear

regression results. Hasson and Arnetz (2005) reported the VAS, when compared to the

Likert scales, has moderate to strong correlations (correlation coefficients between 0.44

0.94). They found strong correlations between related constructs on the VAS and

specific Likert items (r = 0.90-0.94, p < 001. Good, et al. (2001), in a randomized

controlled trial with post-operative patients, report the test-retest reliability of the VAS

between .73 and .82. The VAS scores were also found to be more continuous, making

them more useful in statistical analysis. McCarthy, et al. (2005) confirmed the test-retest

reliability in a study of surgical patients, reporting confidence intervals at 95% with a

significance level of 0.0001. This study also demonstrated construct validity between

VAS scales for surgical pain and the SF-36, a short form scale used for both clinical and

research data collection.

 51

Data Collection

The following information was gathered by the researcher from the participants

medical record either prior to baseline or after discharge: age, gender, diagnosis,

ethnicity, reason for admission to ICU, type of admission (emergency vs. planned), and

length of stay in ICU at time of session In addition, participants completed a music

questionnaire designed by the researcher including the following information: previous

experience with music for relaxation or music therapy, importance of music in everyday

life, and music preferences/tastes (See Appendix C). The questionnaire was

administered following the obtaining of informed consent and prior to beginning any

intervention. The Faces Anxiety Scale and the Visual Analog scale for pain were

administered immediately before the research condition. These same scales were

repeated at the close of the session and at 60 minutes post-session.

ICU patients have constant physiological monitoring of heart rate, respiration rate,

oxygen saturation and blood pressure. Physiological data were collected from the

routinely used monitors. The hospital uses Life Scope A Procyon Plus Bedside

Monitors # BSM 5100 manufactured by Nihon Kohden America. This monitor allows

for a large amount of data to be displayed simultaneously and presented continuous

monitoring of the variables for this study. These physiological measures were recorded

by a student research assistant trained to read the on-going vital signs monitor and print a

trend report after the final data collection time point.

A data log of time and date was kept to identify the participant by an assigned

research number. The FAS and the VAS results were recorded on a data sheet using the
 52

participants assigned research number. The researcher collected these data at pre-session

and the student research assistant was trained by the researcher to collect these data at

both post session data points. When the participant was no longer attached to a

computer monitor with a printer but was on a telemetry recording device, the nurse

assisted the student research assistant in recording the physiological measures by hand, as

they could be easily read from the monitor in the participants room, but were not

available to be printed.

Length of stay in ICU was collected from the participants medical record after

discharge or transfer from the ICU. A list of participants was provided to the Medical

Records Department who provided access to the data. The researcher collected these data

in the Medical Records Department from patient charts. Access to medical records was

available as part of the informed consent process with IRB approval. The number of

hours in ICU post-session was calculated by manually adding together 24 hours for each

full day and the number of hours from a partial day from session time to transfer or

discharge from the ICU.

 53

Table 5
Data Collection Points
Post Session & Post Hospital
Pre Session 60 Post Session Discharge from
Medical Record

Collected by Collected by Collected by Collected by

Researcher Research Assistant Research Researcher
Assistant

Demographic ICU length of stay

questionnaire
Faces Anxiety Faces Anxiety
Scale Scale
Visual Analog Visual Analog
Scale Pain Scale Pain
Heart Rate Heart Rate
Respiration Rate Respiration Rate
Oxygen Saturation Oxygen
Saturation
Blood Pressure Blood Pressure
.

Equipment

Participants in the music medicine group received a battery-operated Sony CR-X

CD player and chose from among the five samples prerecorded on a Phillips CD-RW

music CD. For the music therapy sessions, a battery-operated Sony CD player, a small

battery-operated plastic Casio keyboard and a Fender acoustic guitar as well as song lists

and song lyric books were available.

Data were inputted into statistical software for analysis using IBM SPSS Statistics

Version 19. The following statistics were used in data analysis: multivariate analysis of

variance to examine all physiological measures concurrently, repeated measures analysis

of variance to compare changes within and between groups over time, one-way analysis
 54

of variance to compare demographic characteristics between groups, paired sample T-

tests to compare changes between time points within groups and Kruskal-Wallis test of

one-way ANOVA of ranks to convert the small data set and wide variances for length of

stay between groups.

 55

CHAPTER 4

RESULTS

Data Analysis

This controlled trial included twenty-eight participants randomly assigned to one

of three groups (eight music therapy, fourteen music medicine, and seven attention

control). These twenty-eight participants were recruited from the ICU of a community

hospital based on referrals from the unit nursing staff. From a total of eighty-seven

referrals, thirteen were excluded because they did not meet study criteria; this resulted in

a total of seventy-four eligible referrals. No patient was excluded based on race or

ethnicity provided they possessed an adequate understanding of the English language. Of

the seventy-four eligible referrals, twenty-nine (39%) agreed to participate. See Figure 2

for details of recruitment, allocation and participation.

One participant was withdrawn due to random assignment to the attention control

group when she was in need of music therapy services. Music therapy was provided, and

no data were collected. Twenty-eight eligible referrals were included for whom data

were collected. The data were collected over a one year period from November, 2010

through November, 2011. The music medicine and music therapy groups included both

male and female participants (MM included eight males and five females; MT included

four of each) whereas the attention control group was all female. Twenty-five of the

twenty-eight participants were Caucasian; the MM and MT groups each included one

African-American, and the AC group included one Asian. The MM group included
 56

participants ages 49 to 83 with a mean age of 68.61 years. The MT group included

participants ages 43 to 83 years with a mean age of 58.25 years while the AC group

included participants ages 34 to 79 years with a mean age of 64.57. Independent T-tests

were computed to determine any significant differences in mean ages between groups;

there was no significant difference.


Randomized Allocation
Allocated to Music Medicine (n= 13 )
Received allocated intervention (n= 13 )
Did not receive allocated intervention
(n= 0)
Follow-Up
Analysis
Analyzed (n= 13 )
Excluded from analysis (n= 1 each for
HR, Oxygen Saturation)
Give reasons: missing data
Figure 2 Participant Recruitment and Allocation
Format from Moher, Schulz, & Altman, 2001
57
Participant Flow by Group
Assessed for eligibility (n= 87 )
Participant Enrollment
Excluded (n= 59 )
Not meeting inclusion criteria (n=
13 )
Refused to participate
(n= 45)
Other reasons (n= 1 )
Allocated to Music Therapy (n= 8 ) Allocated to Attention Control (n= 8 )
Received allocated intervention (n= 8 ) Received allocated intervention (n= 7 )
Did not receive allocated intervention Did not receive allocated intervention
(n= 0) (n= 1)
Give reasons: needed MT - withdrawn
Lost to follow-up (n= 0 )
All participants were interviewed 60
minutes post session.
Discontinued intervention (n= 0 )
Analyzed (n=8 ) Analyzed (n= 7 )
Excluded from analysis (n= 1 from Excluded from analysis (n= 0 )
HR,1 from BP, 2 from RR, 3 from
Oxygen Saturation)
Give reasons: missing data
 58

Musical Demographics

In order to determine the music history, preferences and role of music in the lives

of participants the researcher developed a questionnaire to explore musical

demographics. This questionnaire was completed after Informed Consent and prior to

session times. Because of the severity of illness in the ICU, the researcher administered

the questionnaire, asking the participant to respond verbally to the questions. The

questionnaire gathered data about the participants previous experiences with music and

music therapy, music preferences and the importance of music in daily life. When asked

to describe how important music was in everyday life, participants ratings spanned the

range from 1-9 (1 representing I dont care if I have music in my life to 9 representing

I need music every day.) with the largest concentration of participants choosing 8-9

(46.4%). A quarter of the participants rated music at the lower end of the scale; from 1-5

on level of importance. The mean scores for importance of music were similar and

were not significantly different suggesting that the importance of music did not affect

responses across groups. A little more than half of the total expressed a preference for

specific musical sounds and 64.3% reported experience as a musician (either playing an

instrument or singing in a group) at some time in life. Nineteen participants reported

previous use of music to manage stress in everyday life, and two had received music

therapy in the past.

Seven participants were referred to the study on the day of admission to the ICU,

thirteen were referred between days two and four and eight were referred after four days

in the unit. The majority of the participants (67.9%) had some college education.
 59

Participants were asked to indicate preference for a variety of musical genres. A

participant indicated a yes or no for each genre. A composite of participant

preferences is displayed in Table 6. Classical music was most preferred across groups

but not the most popular with participants in the Attention Control group.

Table 6
Music Genre Preferences by Group
Genre Music Medicine Music Therapy Attention Control Totals

Classical 12 7 5 24

Pop 8 7 7 22

Jazz 11 4 3 18

Sacred 8 7 6 21

Easy Listening 11 7 7 25

Rock 11 5 6 22

Big Band 11 6 3 20

Folk 10 4 4 18

Country 9 7 6 22

New Age 3 0 2 5

Other 5 4 4 13

Decision Tree Procedures

The Decision Tree was created to provide a protocol for the research while

offering authentic music therapy treatment for participant. The eight participants in the

MT group received treatment following this protocol (see Table 7 for details). Of the

eight participants, four were engaged in lyric/songwriting. Lyrics created in sessions can
 60

be seen in Appendix D. Three made song choices to express feelings and to explore

coping skills and one participant received music-assisted relaxation interventions. The

participant had experience doing relaxation with music, thus, the therapist improvised

music on the keyboard while the participant closed her eyes and used the music to put

herself into an image of being on the beach. After about 12 minutes, the therapist

stopped playing and waited for the participant to respond. Discussion of the relaxed

feeling followed before moving on to closure (additional relaxation time for this

participant).

Table 7
Music Therapy Interventions
MT Intervention N Initial Song Choice Lyric Writing Topic/Coping Song
Choice
Lyric Writing 4 Rap talked about early Family Support
street wrap
Amazing Grace Inner Peace
No One Comes Back Getting through the day
from Dead Mans Curve
Jan & Dean
You Got A Friend Hope for future
James Taylor

Song 3 Long As I Can See the Popular songs from 40-60s

Choice/Discussion
Light Creedence discussed his life as a young man,
Clearwater Revival found strength in the memories
On and On Stephen Folk and Country songs from 70s
Bishop Country Rock discussed life events, ending with
Blowinin the Wind as a song to
relax
Abide With Me Discussed singing in church, chose
other hymns to sing, talked about
importance of music in daily life

Relaxation 1 Skipped highly anxious Improvised music on keyboard

Nurse offered anti-anxiety patient reported spontaneous
drug encouraged her to images of beach/comfort. Did
wait if possible no drug second improv encouraging her to
taken before or after return to the beach to rest her body
 61

Physiological Measures

Physiological parameters of stress response including heart rate, blood pressure,

respiration rate, and oxygen saturation; these were measured immediately prior to,

immediately after and 60 minutes after the research intervention from the on-going

monitors attached to participants receiving care in the ICU. Baseline testing of

physiological and psychological measures was conducted using one-way analysis of

variance. There were no significant differences between means at baseline for these

measures (See Table 8).

Table 8
Baseline Analysis of Variance
Source of Sum of Mean
Variation Squares df Square F Sig.
Heart Rate
Between 288.88 2 144.44 .530 .596
Within 6268.24 23 272.53
Total 6557.16 25

BPMean
Between 370.32 2 185.16 .534 .593
Within 8318.20 24 346.59
Total 8688.52 26

RespRate
Between 37.27 2 18.64 .931 .409
Within 460.62 23 20.03
Total 497.89 25

Ox Sat
Between 37.33 2 18.67 .757 .481
Within 517.63 21 24.65
Total 554.96 23

Anxiety
Between 5.68 2 2.84 1.757 .193
Within 40.42 25 1.62
Total 46.10 27
 62

Table 8, continued
Source of Sum of Mean
Variation Squares df Square F Sig.
Pain
Between 33.75 2 16.87 1.675 .208
Within 251.78 25 10.07
Total 285.53 27

To answer the research question, is there an effect of music therapy,

music medicine or attention control on physiological response of ICU patients? data

were analyzed using a Multivariate Analysis of Variance to detect potential differences

between dependent variables (heart rate, blood pressure, respiratory rate, and oxygen

saturation) from baseline to post session measurements. There was no statistically

significant multivariate difference among the effects of the three group treatments on the

physiological dependent variables (heart rate, mean blood pressure, respiratory rate or

oxygen saturation). F (15, 24) = .870, p > .05; Wilk's Lambda = .401, partial eta squared

= .367. (Results can be seen in Table 9.) Each physiological variable was then looked at

independently across the three data collection time points. Details of this analysis follow.

Table 9
Multivariate ANOVA for Physiological Dependent Variables a
Multivariate Hypothesis Error Wilks
analysis of df df Lambda F Sig. p2
physiological
outcome
measures
HR, 16 24 .401 .870 .606 .367
BPmean,
RR, Ox Sat
 63

Heart Rate Data Analysis

Pre, Post and 60 minutes Post-session heart rate data were analyzed using a

repeated measures analysis of variance (RMANOVA). Data violated Mauchys Test of

Sphericity, so outcome was adjusted using Greenhouse-Geisser. There was no significant

interaction between groups and heart rate over time, no main effect of group, or main

effect of heart rate over time as seen in Table 10. The hypothesis that music therapy

interventions would result in significantly different medically beneficial physiological

changes in heart rate than music medicine or attention control was rejected.

Table 10
Repeated Measures ANOVA for Heart Rate a
Source of Sum of Mean
Variation Squares df Square F Sig. p2
Within 14.449 1.593 9.072 .245 .733 .011
Between 445.592 2 222.796 .285 .755 .024
Interaction 88.273 3.185 27.712 .748 .538 .061
Error 1345.881 37.041 37.041
a Sphericity Not Assumed Mauchlys Test significant, results adjusted using
Greenhouse-Geisser p = .05

A visual examination of means (Figure 3, Table 11) suggests that music therapy

slightly increased heart rate while the mean for attention control increased more

substantially and then decreased slightly during the post session time.
 64

Figure 3 Heart Rate Scores

Table 11
Mean Heart Rate Scores by Treatment Group
Music Medicine * Music Therapy* Attention Control*
N 12 7 7
T1 T2 T1 T2 T1 T2 T3
T3 T3
Mean 87.833 86.333 80.571 80.857 81.857 86.286
86.083 81.571 83.714
SD 18.600 18.850 15.317 15.582 13.260 17.490
17.650 13.710 14.761
* Missing data for one participant in this group related to monitor error
T1 = pre-session, T2 = post session, T3 = 60 minute post session measures
 65

Blood Pressure Data Analysis

Blood pressure data were collected for systolic, diastolic and mean arterial

pressure measures. Literature suggests that the mean blood pressure score is most

meaningful as it is a weighted score, using two times the diastolic plus the systolic

divided by three because two-thirds of the cardiac cycle is spent in the diastole. The

normal mean arterial pressure range is 70 110; a minimum of 60 is considered

necessary to adequately pump blood to major organs (McAuley, 2011). As mean arterial

pressure is seen as more clinically meaningful, these scores were analyzed using

RMANOVA. Pre, Post and 60 minutes Post-session blood pressure mean data were

analyzed. There was no significant interaction between groups and blood pressure means

over time, no significant main effect of blood pressure means over time, or main effect

for group (see Table 12). The hypothesis that music therapy interventions would result in

significantly different medically beneficial physiological changes in mean blood pressure

than music medicine or attention control was rejected.

 66

Table 12
Repeated Measures ANOVA for Blood Pressure Means a
Source of Sum of Mean
Variation Squares df Square F Sig. p2
Within 391.341 2 195.671 1.913 .159 .077
Between 379.627 2 189.813 .291 .750 .025
Interaction 236.341 4 59.085 .579 .680 .048
Error 4707.650 46 102.275
a Sphericity Assumed Mauchlys Test not significant
p = .05

An examination of means (Figure 4, Table 13) suggests that both experimental

interventions resulted in a slight increase in blood pressure scores, although very small.

All groups experienced slight decreases in blood pressure mean scores during the hour

following the treatment session, however the music medicine and music therapy groups

did not return to baseline blood pressure measures by the end of the hour. The Attention

Control group had a rise and fall in a similar pattern, but the mean arterial pressure for

this group was 4.71 mmHg lower than baseline at the second post session data point.
 67

Figure 4 Mean Arterial Blood Pressure

Table 13
Mean Arterial Blood Pressure Scores by Treatment Group
Music Medicine * Music Therapy* Attention Control
N 12 7 7
T1 T2 T1 T2 T1 T2
T3 T3 T3
Mean 92.667 95.500 87.429 95.143 97.429 102.143
94.250 91.714 92.714
SD 17.758 13.480 17.334 23.922 17.038 13.643 14.174
14.882
* Missing data for one participant in this group
 68

Respiratory rate data analysis. Pre, Post and 60 minutes Post-session respiratory

rate means data were analyzed using a repeated measures analysis of variance

(RMANOVA). There was no significant interaction between groups and respiratory rate

over time and no significant main effect for group. There was a significant main effect of

respiratory rates over time. Post hoc testing revealed that this significant difference over

time was for the three groups from post session to 60 minutes post session (See Table

14). The hypothesis that music therapy interventions would result in significantly

different medically beneficial physiological changes in respiratory rate than music

medicine or attention control was rejected.

Table 14
Repeated Measures ANOVA for Respiratory Rate a
Source of Sum of Mean
Variation Squares df Square F Sig. p2
Within 111.534 2 55.767 3.229 .049* .123
Between 33.488 2 16.744 .237 .791 .020
Interaction 38.551 4 9.638 .558 .694 .046
Error 794.526 46 17.272
a Sphericity Assumed Mauchlys Test not significant
p = .05

A visual examination of group means (Figure 5, Table 15) reveals a similar

pattern for all groups from baseline to a lowered respiratory rate at post session followed

by an increased rate one hour after the session. These changes were slight. No

conclusions can be drawn from this pattern except that the treatment conditions had no

different effect than control.

 69

Figure 5 Respiratory Rates

Table 15
Mean Respiratory Rate Scores by Treatment Group
Music Medicine Music Therapy* Attention Control
N 13 6 7
T1 T2 T1 T2 T1 T2 T3
T3 T3
Mean 21.923 21.000 23.167 19.833 19.857 19.571 22.714
22.307 24.667
SD 3.475 6.124 7.026 9.261 4.462 3.599 6.102
5.006 9.750

* Missing data for two participants in this group

T1 = pre-session, T2 = post session, T3 = 60 minute post session measures
 70

Oxygen Saturation Data Analysis

Pre, Post and 60 minutes Post session oxygen saturation level mean data were

analyzed using a repeated measures analysis of variance (RMANOVA). Data violated

Mauchys Test of Sphericity, so outcome was adjusted using Greenhouse-Geisser. There

was no significant interaction between groups and time, no main effect of group, or for

oxygen saturation over time (See Table 16). The hypothesis that music therapy

interventions would result in significantly different medically beneficial physiological

changes in oxygen saturation than music medicine or attention control was rejected.

Table 16
Repeated Measures ANOVA for Oxygen Saturation a
Source of Sum of Mean
Variation Squares df Square F Sig. p2
Within 2.010 1.246 1.614 .190 .720 .009
Between 89.212 2 44.606 .996 .386 .087
Interaction 4.547 2.491 1.825 .215 .852 .020
Error 221.759 26.159 8.477
a Sphericity Assumed Mauchlys Test significant, results adjusted using Greenhouse-
Geisser, p = .05

A visual examination of these means (Figure 6, Table 17) reveals a slight increase

in oxygen saturation level following music therapy treatment (increased levels are

desirable), but this benefit declined one hour after treatment to near baseline level. Music

medicine had essentially no effect on oxygen saturation, and the control group had no

change after the experimental condition, but had a slight increase in the hour following.

This is shown in Figure 5. In the current study all conditions resulted in a slight rise in

oxygen saturation with only the Attention Control group continuing to rise after the

session. Music Medicine (T1-T2 = +l.8, T2-T3 = - .5) and Music Therapy (T1-T2 = +.8,

T2-T3 = -.6).
 71

Figure 6 Oxygen Saturation

Table 17
Mean Oxygen Saturation Scores by Treatment Group
Music Medicine * Music Therapy* Attention Control
N 12 5 7
T1 T2 T1 T2 T1 T2 T3
T3 T3
Mean 96.500 96.833 94.600 95.400 93.714 93.857
96.333 94.800 94.571
SD 2.908 2.517 2.941 4.930 6.873 4.375
2.461 6.833 4.276

* Missing data participants in this group

T1 = pre-session, T2 = post session, T3 = 60 minute post session measures
 72

Psychological Measures

Anxiety level was measured using the Faces Anxiety Scale. This scale was

administered immediately before the research intervention by the researcher. After the

research condition and at 60 minutes post session this scale was administered by a student

research assistant.

Anxiety Scores Data Analysis

To answer the question is there an effect of music therapy, music medicine or

attention control on anxiety levels in ICU patients? data were analyzed using a repeated

measures analysis of variance (RMANOVA). Data violated Mauchys Test of Sphericity

so outcome was adjusted using Greenhouse-Geisser. There was no significant interaction

between groups and anxiety scores over time, nor was there a main effect of group.

There was a significant main effect of anxiety scores over time (See Table 18). This

indicates that significant differences exist between anxiety measures between data

collection points. In order to understand these differences paired samples t-tests were

conducted to compare anxiety levels pre and post session. This analysis revealed a

significant difference between both treatment groups when compared to the AC group

(See Table 19). Effect sizes for these two groups were calculated comparing pre-session

with post session means for each group resulting in medium effect sizes for both groups

(MT d =.7, MM d = .6). These patterns are apparent in Figure 7. Means across time are

reported in Table 20.

 73

Table 18
Repeated Measures ANOVA for Faces Anxiety Scores a
Source of Sum of Mean
Variation Squares df Square F Sig. p2
Within 5.673 1.633 3.475 8.665 .001* .257
Between 11.250 2 5.625 1.473 .248 .105
Interaction .679 3.265 .208 .518 .687 .040
Error 16.369 40.817 .401
a Sphericity Not Assumed Mauchlys Test significant, results adjusted using
Greenhouse-Geisser
p = .05

Table 19
Student t-test comparisons of pre-session to post session anxiety score changes

Mean SD df t Sig.
Music therapy pre .750 .886 7 2.393 .048*
post session
Music medicine .846 1.214 12 2.513 .027*
pre post session
Attention Control /285 .488 6 1.549 .172
Pre-post session
p = .05
 74

Figure 7 Anxiety Scores

Table 20
Mean Anxiety Scores by Treatment Group
Music Medicine Music Therapy Attention Control
N 13 8 7
T1 T2 T1 T2 T1 T2 T3
T3 T3
Mean 3.154 2.385 2.375 1.625 2.143 1.857 1.857
2.462 1.750
SD 1.520 1.325 1.188 1.060 .690 .899 .899
1.391 1.391

T1 = pre-session, T2 = post session, T3 = 60 minute post session measures

 75

The hypothesis that music therapy interventions would result in a significantly

larger decrease in anxiety scores than changes resulting from music medicine or attention

control was rejected. Both music therapy and music listening resulted in significantly

larger decreases in anxiety scores than attention control.

Pain Scores Data Analysis

Pain level was measured using a Visual Analog scale. These data were collected

by the researcher immediately prior to the research condition and repeated by a student

research assistant after the research condition and at 60 minutes post session.

To answer the question is there an effect of music therapy, music medicine or

attention control on pain of ICU patients? data were analyzed using a repeated measures

analysis of variance (RMANOVA). Data violated Mauchys Test of Sphericity, so

outcome was adjusted using Greenhouse-Geisser. There was no significant interaction

between groups and time. There was no main effect of group or of pain scores over time

(see Table 21).

Table 21
Repeated Measures ANOVA for Pain Scores a
Source of Sum of Mean
Variation Squares df Square F Sig. p2
Within 3.975 2 1.987 `.752 .184 .065
Between 48.407 2 24.203 .989 .385 .073
Interaction 6.935 2.953 2.349 1.529 .224 .109
Error 56.713 36.907 1.537
a Sphericity Not Assumed Mauchlys Test significant, results adjusted using
Greenhouse-Geisser, p = .05
 76

A visual examination of means (Figure 8, Table 22) indicates that both music

medicine and music therapy resulted in a decrease in pain levels; these levels remained

below baseline one hour later at follow-up testing. The control group demonstrated a

slight decrease in pain level after the visit, but an increase an hour later. A paired sample

t-test comparing pre-session and post session scores (see Table 23) revealed a significant

difference in the decrease in pain scores for the music medicine group thus the hypothesis

that music therapy interventions would result in a significantly larger decrease in pain

scores than changes resulting from music medicine or attention control was rejected.

Figure 8 Pain Scores

 77

Table 22
Mean Pain Scores by Treatment Group
Music Medicine Music Therapy Attention Control
(MM)
N 13 8 7
T1 T2 T1 T2 T1 T2 T3
T3 T3
Mean 3.577 2.692 2.500 1.875 .857 .786 1.286
2.307 2.125
SD 3.812 3.269 3.128 3.181 1.214 1.074 1.976
3.166 3.090

T1 = pre-session, T2 = post session, T3 = 60 minute post session measures

Table 23
Student t-test comparisons of pre-session to post session pain score changes

Mean SD df t Sig.
Music therapy pre .625 1.620 7 1.091 311
post session
Music medicine .846 1.214 12 2.513 .027*
pre post session
Attention Control .071 .189 6 1.000 .356
Pre-post session
p = .05
Length of Stay Data Analysis

To answer the question is there an effect of music therapy, music medicine or

attention control on length of stay for patients in ICU?, a one-way ANOVA was

conducted. Levenes statistic indicates that the assumption of homogeneity of means had

been violated; p < .001, therefore Welchs Robust Test of Equality of Means was used.

There was no significant difference between groups (see Table 24). Figure 9 shows the

wide variance in length of stay means.

 78

Table 24
One-way ANOVA length of stay a
Source of Sum of Mean
Variation Squares df Square F Sig.
Within 1298422.116 10.840 51936.885
Between 269776.701 2 124888.351 2.817 .103
Error
a
Levenes test of homogeneity of means violated, results adjusted using Welchs Robust
Test
p = .05

Length of Stay Means Comparison by Treatment Group

Figure 9 Length of Stay

 79

One member of the music medicine group had a substantially longer length of

stay (644 hours), and two members of the control group had lengths of stay beyond 900

hours. These possible outliers in such small data sets make the comparisons meaningless.

In order to examine these data with a more meaningful analysis, the Kruskal-Wallis test

of one-way ANOVA of ranks was used. This test was chosen as it is robust in the face of

small data sets and wide variances. This was preferable to eliminating the potential

outliers as the small number of participants in the music therapy and attention control

groups would have decreased as much as 30%, and such a small data set makes it

difficult to identify the two widely varied results as outliers with so little for comparison.

The conversion to ranks can be used to establish a more accurate representation of the

differences among groups. Overall comparison of groups was not significant. The

difference between the two treatment groups, music medicine and music therapy was not

significant; however the difference between music therapy and attention control was

significant (see Table 25). Because of the wide variance at baseline, these results must be

interpreted with caution (See Table 26). Despite this significant difference between

music therapy and the control groups length of stay, the hypothesis stating music therapy

interventions would result in shorter length of stay in the ICU than music medicine or

attention control is rejected as there was no significant difference between music therapy

and music medicine.

 80

Table 25
Kruskal-Wallis One-way ANOVA of Ranks for length of stay
Comparisons
N H df Sig.
Music Medicine/Music
Therapy/Attention Control 28 5.85 2 .054
Music Medicine/Music Therapy 21 2.314 1 .128
Music Medicine/Attention Control 20 .454 1 .500
Music Therapy/Attention Control 15 7.085 1 .008*
p = .05

Table 26
Mean Length of Stay (in hours) by Treatment Group
Music Medicine Music Therapy Attention Control
N 13 8 7

Mean 146.484 66.5 329.0

SD 162.936 18.7 403.6
 81

CHAPTER 5

DISCUSSION

This study examined the effects of music therapy (MT), music medicine (MM), or

attention control (AC) on physiological and psychological parameters of stress for adult

and older adult patients receiving care in the ICU of a community hospital. Participants

(twenty-eight adults, ranging in age from 37-83 years; not mechanically ventilated at the

time of the session) were randomly assigned to MT, MM or the AC group. Repeated

measures of heart rate, blood pressure, respiratory rate, oxygen saturation, and anxiety

and pain levels were collected before the session, immediately after the session and at 60

minutes post-session. Overall, there were no significant interactions among study groups

and outcome measures. From pre-session to post-session there were statistically

significant decreases in anxiety scores for both MM and MT groups. Pain scores

decreased significantly for the music medicine group between pre and post session and

continued to decline at 60 minutes post-session. Respiratory rates were significantly

lower within groups over time from post-session to 60 minutes post-session.

Description of Participants

Participants were twenty-eight patients recruited from the ICU of a community

hospital, randomly assigned to one of three groups (eight MT, fourteen MM, seven AC).

The music medicine and music therapy groups included both male and female

participants (MM included eight males and five females; MT included four of each)

while the attention control group was all female. All participants were Caucasian with

the exception of one member of each group. The mean age of the MM group was 68.61
 82

years. The mean age of the MT group was 58.25 years; the AC group mean age was

64.57 years. More than half of the twenty-eight expressed a preference for specific

musical sounds, and 64.3% reported experience as a musician at some time in life.

Nearly half (46.4%) reported that music was important in daily life (8 or 9 on a

scale of 1-9 with 9 indicating I need music in my life daily). In contrast, 25% of

participants reported that musics importance was 5 or less on that same scale. The

importance of music in daily life may be a reflection of the individuals relationship to

music. This is important in looking at data about the effects of music on measures

associated with stress. It would seem that persons who place a high level of importance

on music in daily life would be more likely to respond to music interventions in a medical

environment. Mitchell, MacDonald, and Knussen (2007) found that the self-reported

importance of music was positively correlated with the need for less medical care and an

increased likelihood of using music to manage pain. The authors suggest that those who

feel music is important are more likely to initiate its use and find it effective. Because the

mean scores in the present study were all above the middle of the scale, and 46% were at

the high end of the scale, the importance of music to these participants may have played a

role in the effectiveness of music and music therapy interventions.

The connection to music may influence a participants relationship to music and

increase its potential beneficial effects. Participants reported very specific musical

preferences which are described in detail in Table 6. Participants were especially fond of

classical music, easy listening, pop, rock, and country, whereas they expressed little
 83

interest in New Age style music. This may be a reflection of the ethnic homogeneity of

the sample.

Heart Rate Discussion

Heart Rate has been used as an outcome measure in both music medicine and

music therapy research (see Table 3). A meta-analysis of cardiology/ICU studies (Dileo

& Bradt, 2005) revealed a small effect size (r = .21) with a total participant pool of 606.

The current study, with twenty-eight participants, demonstrated no statistically significant

results for heart rate. Data do show a decrease in heart rate for the MM group from

baseline to post-session (change -1.5) and an increase in heart rate for both MT and AC.

(MT increased 0.3 while AC increased 4.5). This is in contrast to both the Cardiac (Bradt

& Dileo, 2009) and Mechanical Ventilation (Bradt, Dileo & Grocke, 2010) Cochrane

Reviews which found significant decreases in heart rate for music medicine interventions.

The discrepancy may be related to the small sample size in the current study. Numerous

recent studies have also reported no significant decrease in heart rate (Allred, et al., 2010;

Binns-Turner, et al., 2011; Ebneshahidi & Moshseni, 2008; Korhan et al., 2011; Lin, et

al., 2011; Nilsson, 2009; Vaajoki, et al., 2011). Bernardi, Porta and Sleight (2006)

reported an increase in heart rate proportional to the tempo of the music. Music therapy

group participants had chosen songs that had personal meaning related to a discussion of

their hospital experience and their coping skills. These songs were not all slow and

relaxing, and thus the faster tempi may be responsible for the increase in heart rate for

MT group participants. Increases for the AC group are not easily explained as most of
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these participants watched TV or rested during the befriending. Heart rate change could

have been impacted by timing of medication or by the participants medical condition.

Blood Pressure Discussion

Blood pressure has been used as a measure of effectiveness in both music

medicine and music therapy research (See Table 3). However, studies show mixed

results. A meta-analysis revealed a small effect size (r = .17) without statistical

significance (Dileo & Bradt, 2009) with a total participant pool of four-hundred sixty-

eight. The current study, with twenty-eight participants, demonstrated no statistically

significant results. The Cardiac Cochrane Review (Bradt & Dileo, 2009) did find

significant effects of music medicine on both systolic and diastolic blood pressure,

whereas the Mechanical Ventilation Cochrane Review (Bradt, Dileo & Grocke, 2010) did

not find significant results, but like this current study, did demonstrate decreases in mean

arterial pressure along with decreases in diastolic blood pressure. One additional study

(Conrad, 2007) was described in the Mechanical Ventilation Cochrane Review reporting

significant differences in blood pressure. This Conrad study was not included in the

statistical analysis because no means or standard deviations were reported. Recent music

medicine studies have found significant decreases in systolic, diastolic and/or mean

arterial blood pressure (Binns-Turner, et al., 2011; Dijkstra, et al., 2010; Han, et al., 2010;

Lin, et al., 2011; Korhan, et al., 2011; and Vaajoki, et al., 2011). Several studies found

no significant change in blood pressure (Allred, et al., 2009; Ebneshahidi & Mosheseni,

2008; Nilsson, 2009). In the current study, blood pressure for both experimental groups

increased from pre-session to post session, but decreased by 60-minute post session data
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collection. This pattern for the MM group is consistent with Bernardi, et al.s (2006)

findings that passive listening to music increased blood pressure, whereas random periods

of silence (pauses) induced decreases in blood pressure. The MT group participants were

engaged in talking, singing, and discussing thoughts and feelings related to

hospitalization and coping; this activation may have resulted in blood pressure increases.

During the music therapy session time, engaging in music may have activated the

participants autonomic nervous system and led to a rise in pressure. This arousal may

account for rises in blood pressure during the session and decreases after the session.

During the post session hour, many confounding variables were present in the intensive

care unit. After sessions, participants received visitors, were served dinner, received

medications, treatments and in-room x-rays as well as visits from doctors, social workers

and other hospital personnel. In addition, no research records were kept of administration

of blood pressure medications so it is not possible to analyze the possible effects of these

drugs on changes in blood pressure.

Respiratory Rate Discussion

Respiratory rate changes were statistically significant in Dileo and Bradts meta-

analysis (2005) and in both the Cardiac (Bradt & Dileo, 2009) and Mechanical

Ventilation (Bradt, Dileo & Grocke, 2010) Cochrane Reviews. The small number of

participants in the current study limits the usefulness of the findings, but it is worthy to

note that music therapy did slow respirations for participants. The respiratory rate for

healthy adults is 12-20 beats per minute (Normal Respiratory Rate, n.d.). Music Therapy

participants mean was 23.17 at baseline and 19.83 after the sessions, assisting
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participants in slowing breathing to a more normal range. This did not continue into the

post-session period; by 60 minutes after the session the respiratory mean had risen to

24.67. Music therapy interventions did lower respiratory rates regardless of whether the

participant sang along or listened to the therapist sing. It may be that the singing or

discussing songs helped to deepen inspiration and slow breathing. MM participants,

breathing changed from pre-session to post-session less than one respiration per minute.

In these sessions, the participant was not speaking, and breathing may have been affected

by confounding variables, as some participants rested quietly while listening, and others

may have been more attuned to noises outside the hospital room in the unit hallways.

During the post session hour, participants may have experienced physiological arousal as

a result of medical care, visitors, eating dinner and other physical activity.

In the MM and MT groups, just over half of the participants reported past

experience as a musician, whereas in the AC group, all but one participant reported a

musical past. Bernard et al., (2006) found that musicians breathed more rapidly while

listening to music at faster tempi and musicians had a lower baseline respiratory rate. In

the current study, the AC group did have the lowest baseline scores; the MT participants

had the highest mean which was the most responsive to the intervention.

Oxygen Saturation Discussion

Oxygen saturation does not appear to be sensitive to music or music therapy

interventions as seen in this study and in much of the literature. A study by Chan, et al.

(2006) did reveal positive changes, however meta-analyses of cardiac/ICU patients

(Dileo & Bradt, 2005) and Cochrane Reviews (Bradt & Dileo, 2009; Bradt, Dileo &
 87

Grocke, 2010) did not find any positive effects of music on oxygen saturation. In the

current study, all conditions resulted in a slight rise in oxygen saturation with only the

AC group continuing to rise after the session. The rise in oxygen saturation for the MT

group may have been related to singing, as three of the eight participants sang with

enthusiasm, whereas three other participants sang quietly for parts of songs. The MM

group may have increased their oxygen saturation as breathing deepened in response to

resting in bed during the music listening time. Most of the AC group participants either

watched television or rested/napped during the befriending experience (one chose to talk

about her love of music since she did not get to have a music session). This quiet time

may have accounted for the increase during the session time, as rest may deepen

breathing and increase oxygen saturation levels. In the current study, no members of the

MM group had oxygen saturations levels below 90%, only one MT group member had a

level below 90%, and only two members of the AC group had readings below 90%. This

may have affected the amount of change possible. The changes in all groups were very

small. Bradt, Dileo and Grocke (2010) reported that oxygen saturation may not be as

sensitive as other measures, because patients who are near 100% oxygen saturation have

little room for improvement.

Anxiety Scores Discussion

Anxiety levels decreased significantly within groups over time for all groups

combined. Listening to music has been shown to significantly affect anxiety levels in

cardiac, surgical and ICU patients (Bradt & Dileo, 2009; Bradt, Dileo & Grocke, 2010;

Dileo & Bradt, 2005). The current study found a difference from pre-session to post-
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session for all groups, with a significant difference over time for both experimental

groups. From pre-session to post-session, MM group participants decreased the most

with MT group participants demonstrating only a slightly smaller decrease in anxiety

scores (0.01). Music medicine and music therapy interventions can be useful in

decreasing anxiety levels for patients. Salamoi, Kim, Beaulieu, & Stefano (2003) suggest

that a complex interrelationship within the central nervous system is responsible for

musics effect on anxiety. Recent research examining the neural pathways in the

amygdala suggests that chronic stress (repeated events over 7-9 days in this study)

increases emotional responses to anxiety. This occurs through increased excitability of

neurons mediated by potassium channels which is likely to lead to an overactive anxiety-

related circuit and in turn decrease other brain activity that would decrease amygdala

activation (Rosenkranz, Venheim & Padival, 2010). This discovery that stress alters

neuron functioning may help to explain how music, as an auditory stimulus, impacts

neural activation, much like the Gate theory (DeLeo, 2006) offers an explanation for the

decreased perception of pain. If the neural pathways are responding to alternate stimuli,

perhaps they are unable to respond with the excitability as reported by Rosenkranz, and

colleagues.

It is also possible that anxiety levels for both treatment groups declined because

the participants received an intervention in addition to standard care. This extra attention

may have resulted in positive feelings about the hospital environment, thus reducing the

stressful effects of the ICU environment.

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Pain Scores Discussion

Dileo and Bradt (2005) reported mixed effects for music medicine or music

therapys effect on pain across population groups. However, in a Cochrane Review of

Cardiac Studies, Bradt and Dileo (2009) reported a statistically significant effect of

music, and more recent studies with surgical patients also showed a significant effect of

music on pain (see Table 3). In the current study, the AC group mean was lowest at

baseline and had the smallest change. Both MM and MT sessions resulted in a .8

decrease in pain scores from pre-session to post session resulting in significance for MM

group only. The MT group comprised half the number of participants of the MM group;

this may explain the statistical difference, but does not alter the presence of a decrease in

pain for both conditions. In the MM group, 70% of participants reported pain, whereas

only 50% of the MT group and 42% of the AC group reported pain at baseline. These

differences may well have influenced the statistical calculations.

Music medicine and music therapy both decreased pain for patients receiving

intensive care. This decrease in pain is sometimes explained via the Gate theory

(Sarafino, 1997) which posits that the neurons that respond to sensory input are larger

and respond more quickly than those that respond to pain. According to this theory, once

the sensory neurons have been activated, the gate is closed and the pain neurons cannot

fire.

Distraction and refocusing attention are also possible explanations for the impact

of both MM and MT on participants pain perception. Bradshaw, Donaldson, Jacobson,

Nakamura, & Chapman, (2011) concluded that music listening can reduce responses to
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pain, especially for persons who are anxious or who are able to easily become absorbed

in alternate activity. Music medicine (involving music listening) and music therapy

interventions offer an opportunity for the individual to become engaged in an alternate

focus of attention.

Pain perception may also have been altered by the presence of an additional

intervention to the care of the experimental groups. Both MM and MT groups received

attention beyond standard medical care, and this may have altered how the participants

perceived the environment. Ashby, Isen and Turken (1999) developed a theory to

explain how positive affect alters brain chemistry and cognition, thus possibly explaining

why a change in perception of the environment could alter the participants perception of

pain.

Length of Stay as a Dependent Variable

Length of stay as an outcome measure does not appear in many music medicine or

music therapy studies. Walworth, et al. (2008) measured length of stay for post-surgical

patients who received live music therapy sessions and found no significant difference

between the treatment and control groups. Schwartz (2009) reported a statistically

significant decrease in length of stay for surgical patients who received music medicine

in the ICU. Schou (2008) reported a decreased length of stay for the music therapy

treatment group in the ICU, but these findings were not statistically significant. The

current data demonstrated no significant differences between groups for length of stay in

the ICU using parametric statistical testing; however, when MT was compared with AC

using non-parametric ANOVA of ranks, there was a statistically significant difference.

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It is of note that both small sample size and wide variances in length of stay may have

played a role in this outcome, as the baseline data varied widely. The Kruskal-Wallis

one-way analysis of variance is designed for small data sets with wide variance. Despite

the results of this test, it is difficult to conclude that treatment played a role in this

difference. It is not possible with such a small sample to even determine if the three

participants who had lengths of stay that were much longer than the others are outliers,

because there is too little comparative evidence with which to make such a decision.

Length of stay in the ICU may also have been influenced by the availability of

beds on other hospital units. The researcher often heard the nurses on the unit state that a

patient was ready for transfer, but they were waiting for a bed to become available. Some

of the participants in this study had orders to be transferred to another unit, but never left

the ICU because unexpected medical crises arose prior to their transfer necessitating

more time in the ICU.

Music Choices and Interventions

The MT group received treatment according to a protocol that included the use of

a song choice procedure. In order to facilitate choices, the music therapist carried a

songbook with lists of songs from various genres (Old Standards, Pop, Country,

Inspirational, Patriotic, Musicals, and Decades -1900s-1980s). In all but one case, the

music therapy participants were able to name a song to describe their hospital experience

without consulting the lists. The lists were used to choose additional songs. No one genre

was selected more than another; however, older participants chose more hymns and old

standards whereas younger participants selected more country and pop songs.
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The music therapy sessions used song writing/parody writing most often (four of

eight participants). Each participant was assisted in creating lyrics, and in one case an

original melody, to express something that helped the participant to cope with stressors,

to feel stronger or to feel supported. The song lyrics for these four participants focused

on family, leisure activities and specific coping skills. The three participants who were

engaged in song choice/singing and discussion chose songs that helped them to tell their

story and connected them with known ways of coping with distress. One participant,

who was engaged in relaxation while the music therapist improvised on keyboard, had

some previous experience with relaxation to music and decided to forego an

administration of an anti-anxiety drug until after the session to see if she could do without

it. She was able to relax and calm herself enough that she did not take the medication

after the session.

The MM group chose from five CDs compiled by the researcher to include

relaxing music. These pieces were chosen based on the researchers clinical experience

and knowledge that music which mimics resting heart rate (60-80 bpm) with little

dynamic change is preferable for relaxation (Bonny, 1986). The classical music from

Music for the Imagination (Bruscia, 1998) was chosen most often (six of thirteen

participants); piano music (Follet, 1994) was chosen five times and New Age style

classical music (Kobialka, 1992, 1990) was chosen by two participants. This is

consistent with the musical preferences of the sample as twenty-four of twenty-eight

people listed classical music as a preference. Interestingly, only five listed new age style

music as a preference, but the New Age style classical music was chosen twice. Of the
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thirteen music medicine participants, eleven chose either the traditional classical music or

the piano music, which was composed for relaxation and is in a somewhat classical style.

The other CDs prepared for the study were not chosen, although two participants asked if

they could listen to both as it was difficult to choose. When participants were interested

in more than one CD, they usually chose the classical or piano, but were most often

choosing between those two or the CD with organ and hymns. No one chose the

specially-arranged music for relaxation in a New Age style or the spiritual music as a first

choice. All participants reported that they liked at least one or two of the CDs, although

one music medicine participant did report after her session that she had wanted a bit more

movement in the melodies.

Methodological considerations

Potential Intervening Variables

As the study progressed, nurses on the unit became more and more supportive of

music therapy as an intervention and excited to make it available to their patients. Some

of these nurses would make positive comments to the patients after Informed Consent

suggesting that they would benefit from the intervention. The nurses attitude may have

biased the participants response to the intervention.

Participants were aware of the intent of the research as it was included in the

Informed Consent as part of the explanation for the study. This knowledge of purpose

may have led some participants to exaggerate the benefits of music medicine or music

therapy in order to promote the interventions or to please the researcher. This

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Hawthorne effect is often used as an explanation for the effects of the extra attention

received by study participants (Merrett, 2006).

Participants physiological data may have been affected by the various

medications in use for these patients. Medication administration was not monitored prior

to or following session times, but many of the participants were receiving IV medication

during the sessions. These may have been heart and blood pressure medications,

antibiotics, anti-seizure and antianxiety drugs. All of these may have altered the

participants physiological responses and changed potential outcomes.

Practical Problems

Conducting research in the intensive care unit of a hospital presents the possibility

of multiple obstacles. Data collection points may be influenced by other activity on the

unit that could delay or prevent collection of data as scheduled. To minimize this

problem, the researcher trained the student research assistants to be responsible for

recording the baseline pre-session, post-session and 60 minute post-session physiological

data from the computer monitor as unit staff were not always available to assist. Data

collection was compromised for several participants early in the study when the nurse

disconnected the computer monitor prior to the trend report being printed. There were

also times when the equipment did not provide a reading of a specific outcome measure,

such as mean arterial pressure; however, these were able to be computed from the

readings available on the trend report.

The acute medical condition of ICU patients can prevent willing participants from

completing the study, as medical needs may arise during the time required for the
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research condition. Every effort was made to work with the ICU staff to minimize all

other potential disruptions, such as medication administration (by checking on timing of

medication schedule before beginning session) and scheduled tests or treatments (by

checking the participants schedule before planning a research intervention). Whereas

this did not prevent all interruptions, no session was interrupted for longer than the two

minute window planned in the design, and no sessions were discontinued because of need

for medical care. For one music medicine participant, a hospital staff arrived to do a

portable test in his room while he was listening to the music. After being educated about

the research and the music medicine intervention the patient was experiencing, the

hospital staff member agreed to wait until the music finished playing before interrupting

the participant. This level of support and cooperation was very helpful because

participant recruitment was such a difficulty.

The model of this study which used the researcher to deliver both interventions and

the control condition introduced the possibility of researcher bias in interpreting the data.

The researcher was diligent to remain aware of this possibility and enlisted the assistance

of a statistical reviewer to maintain integrity in the analysis.

The use of the researcher/music therapist to recruit, administer informed consent,

explore music listening preferences, provide CD delivery and conduct the music therapy

sessions may have biased the results. For example, the parallel drop in anxiety levels

between the MM and MT groups may be due to more than the music. The music

therapists multiple roles and contact with the music medicine participants prior to the

intervention may have forged the beginnings of a therapeutic relationship which

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enhanced the participants response to the music medicine intervention. It was not

possible to help the participant complete the demographic questionnaire without talking

about the participants relationship to music. Despite the use of a standardized script to

help the participants in the MM group choose a CD for listening, earlier contact to collect

baseline data may also have affected how the participant responded to the music. This

contact with the therapist may have had an impact on the music medicine participants that

was not intended. The original intent was to have the music therapist meet only with

music therapy group participants and to have volunteers deliver the music and attention

control conditions. This was to control for the presence of the therapist in the music

therapy session while avoiding establishing a relationship with the music medicine

participant. Because of concerns about supervising volunteers to follow the protocol, the

researcher assumed responsibility for assisting the MM participants in choosing music

and setting up the session and for implementing the befriending protocol with the AC

group participants.

Use of student data collectors created scheduling problems that limited the

available time slots for research. Music therapy student schedules were subject to school

and class needs, music rehearsal and performance commitments and school vacations.

The Unit Manager provided a late afternoon, early evening time slot for research work,

but students often had classes or ensemble rehearsals which conflicted with the available

time slot.
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Limitations of the Study

This study can best be described as a pilot examination of the effects of music

therapy vs. music medicine vs. attention control in the intensive care unit. The small

participant pool decreased statistical power, thus increasing the chance of Type II error.

One way to address this potential problem was to limit the number of statistical tests used

with the data set. Each test splits the total error into small bits, and thus increases the

chances of a Type II error. Consequently, repeated measure ANOVAs were conducted on

each dependent variable and paired sample t-tests were only run for those variables that

showed significance.

Participant recruitment was difficult for a number of reasons. First, the criteria for

inclusion had an upper age range, and experience revealed that this excluded some

elderly patients who were alert, oriented and potential participants. Some potential

participants declined to participate when they learned of the random assignment to

experimental or control interventions, as they did not wish to risk not having music.

(Music therapy services were provided to those patients outside the research study, and

no data were collected.) Some potential participants declined to join the study as they

were feeling too ill; some did not know about music therapy and did not embrace the

idea. Some potential participants were expecting family members or other visitors,

whereas others had physical needs to be met, such as being put back in bed, getting out of

bed, waiting for pain medication or other bodily needs. Some potential participants

expressed a desire to sleep and others expressed no interest in music.

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These difficulties coupled with the frequent research days when no patients met

the inclusion criteria made recruitment of adequate numbers of participants very difficult.

Over the one year period, there were fifteen research days scheduled when no patients on

the unit met eligibility criteria for inclusion. There were ten scheduled research days

when eligible, referred patients declined to participate.

Learning how to explain the study evolved over time as the researcher quickly

learned that if the discussion started with explaining music therapy, the potential

participant was more likely to be disappointed when told that assignment to groups in the

study was random. Some patients still consented and were very happy if they received a

music intervention. Starting the conversation with an explanation of the research study

was less effective, so the researcher developed an approach that began by introducing

herself as the music therapist, explaining that she was doing a research study and then

asking the patient if he/she knew about music therapy. If not, the researcher explained

the music therapy process briefly and asked if the patient might be interested in hearing

more about the research. Of those eligible, referred patients, 39% consented to

participate in the study.

Some participants in isolation rooms were included in the study; one in the music

therapy group, two in the music medicine group and one in the attention control group.

For the music therapy session, this precluded taking the guitar into the room, as it would

have been difficult and potentially damaging to disinfect the guitar. The plastic keyboard

was taken into the room and used for the session. This did not have any negative impact

on the session, as the therapist was able to sing and play the songs requested by the
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participant. The CD player and CDs were taken into the isolation rooms and disinfected

after the session. For the participant in the attention control group, the researcher donned

gown, gloves and a mask and sat at her bedside.

Implications for Research

To conduct research in an intensive care unit requires the cooperation of many

hospital personnel. Despite many hours of talking with the Unit Manager, meeting with

the Intensivist and providing educational programs to unit staff, there were many

difficulties in the early days of the study. Staff turnover was high, and nurses worked 12-

hour shifts, so the rotation of their schedules meant that specific staff members were seen

on a Wednesday and not seen again on a research day for several days or even weeks.

Each day was a new opportunity to educate a new nurse about the study and music

therapy. The process got easier over time, as more staff recognized the research team and

expressed enthusiasm about music therapy. After a few months of visiting the ICU,

nursing and social work staff were ready with referrals for music therapy sessions, both

for the research project and for ineligible patients in need of music therapy services. This

was an indicator that unit staff was gaining a deeper understanding and appreciation for

what music therapy had to offer to the patients in ICU.

It was apparent very early in the study that some nurses were very protective and

possessive of their patients. One nurse chastised the researcher for seeing her patient

when she was unavailable (the charge nurse had cleared the session), but after an honest

discussion with the nurse about the purpose of the sessions and how music therapy or

music medicine could support her patients, she became a supporter of the work and was
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helpful. Building such alliances with unit staff proved to be very helpful in this study,

especially because the researcher was not an employee of the hospital.

Implications for Clinical Practice

The study results do support, to some extent, earlier work demonstrating the

effectiveness of music interventions to decrease anxiety and pain for medical patients.

This current study limited music therapy interventions to song choice, singing, lyric and

song writing and relaxation techniques. Patients in intensive care may benefit from more

active engagement in music-making, such as playing hand held percussion, strumming an

Omnichord or using a small glockenspiel or keyboard for improvisation. Whereas

several of the participants had tubes and IVs and other medical devices that would

preclude active music-making, others had at least one hand available to make music.

Thus more active involvement in the music-making process may have been beneficial for

some patients.

Music therapy and music medicine had a beneficial impact on anxiety scores

which may encourage music therapists to advocate for providing more music therapy for

medical patients whenever possible. The positive impact of music medicine interventions

(especially in this study where the intervention was more closely aligned with receptive

music therapy than non-music therapist administered music medicine) supports the

benefits of receptive music therapy techniques.

Pain scores also decreased within groups for all conditions, with music medicine

reaching a significant level. The music therapist who is aware of the potential for both

music medicine and music therapy interventions to address pain and anxiety can develop
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a caseload schedule that allows those with the most acute needs to receive music therapy

and those who may benefit from the music, but have less acute needs, to receive a music

medicine intervention.

Respiratory rates appear to be affected by music medicine and music therapy, as

scores were decreased from pre-session to post-session. Involving patients in singing,

talking about themselves and the experience of hospitalization and illness may activate

the diaphragm and increase the depth of respirations, thus slowing the rate. When

engaging patients in relaxation experiences, a part of the intentional focus may be on

slowing and deepening the breath.

Implications for Education and Training

Preparing students and interns to deliver music therapy services to hospital

patients, especially those in intensive care, requires an understanding of both the needs of

this population and the music therapy interventions that have demonstrated effectiveness.

The three techniques used in the music therapy intervention in this study required both

musical skills and therapeutic skills. Students and interns in clinical training need to

develop a repertoire of songs in many genres along with the musical skills to accompany

those songs on a portable instrument to be able to provide patients with meaningful

musical experiences. A music therapist in a medical setting needs to develop song-

writing skills, especially lyric-creation based on the information the therapist is able to

glean in a short assessment at the opening of the session. It is important for the therapist

to balance offering too much help with allowing the patient to create as many of the lyrics

as possible. It was helpful in the research sessions to listen to those things the participant
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presented as meaningful and/or related to previous coping and refer back to them during

the lyric creation. The therapist also needs to be able to improvise or have memorized

music that is appropriate for music-assisted relaxation experiences. The more facility the

music therapist has with these techniques, the more flexible and individualized the

session can be in the moment.

Interacting with critically ill patients who are in a fragile physical state, with

potential anxiety, and other psychological symptoms related to the stress of the

environment and their illness, requires that the therapist be skilled in verbal therapy

techniques. Basic verbal skills have been defined by Okun and Kantrowitz (2008) to

include;

(a) making minimal response, e.g. yes or right, (b) paraphrasing, (c)

reflecting, (d) asking questions which may be open or closed-ended, leading, or

reframing, (e) clarifying, (f) interpreting, (g) confronting which should be done

cautiously and gently with critically ill persons, (h) informing, (i) summarizing,

and (j) processing the relationship (p. 75).

Effective music therapy with critically ill patients in a hospital requires that the

music therapist have some medical knowledge. Even before seeing the patient, reading

the chart requires some familiarity with the common abbreviations used in medical

settings and an understanding of what information can be gleaned from the medical

record vs. what information is most readily available from the patients caregivers (nurse,

social worker, family members). This information is not regularly included in

undergraduate music therapy training, unless the student has the opportunity to do field
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work or internship in a medical setting. Even with this experience, there is a limit to how

much of this complex information can be integrated during a semester of field work or an

internship.

Medical hospital work involves contact with persons when they are most

vulnerable. This vulnerability can lead to irritability, withdrawal, depression, anxiety and

lack of compliance with treatment. A music therapist must be able to withstand the

reality of being rejected when offering services, and in fact, must be able to recognize

that allowing the patient to take control of that moment in time and send the music

therapist away may have therapeutic benefits, as it allows the patient to control one small

aspect of his/her environment. The music therapist is wise to leave with a question

requesting permission to return again to try on another day. The music therapist must

also be prepared to repeat this process as many times as necessary in order to meet the

patients needs.

Medical settings have as their primary goal the healing and curing of illness and

injury. The harsh reality of these settings is that not every patient recovers. Music

therapists working in this environment must score high on the hardiness scale; they must

have the inner resources to invest emotional energy in patients who may not survive. The

music therapist must also be able to tolerate the many medical requirements of the

patients treatment, including tubes and drains and needles and blood and other bodily

fluids. This is not an environment for the squeamish or delicate in nature.

Specialty training for music therapists has been developed for neonatal intensive

care, for hospice and for advanced methods, including Guided Imagery and Music-The
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Bonny Method, Nordoff-Robbins Creative Music Therapy and Analytical Music

Therapy. Working in a medical setting requires, at the very least, experience in the

setting and knowledge of medical terminology and common practice. Ideally, medical

music therapy is provided by a music therapist who has developed music skills that allow

for a variety of musical interventions; verbal skills that allow for managing the discussion

that is likely to arise when a patient is struggling with the realities of illness, injury and/or

possible death; medical knowledge to allow the therapist to more fully understand the

needs and circumstances of the patients and has the personal qualities that allow the

music therapist to tolerate the medical needs of the patients. In the music therapy

profession today, these skills begin in undergraduate field work and internship and are

developed either through work experience (ideally with good clinical supervision) or

through advanced training in a masters degree program with a focus on medical music

therapy. As the profession moves to masters level entry, it may be necessary to develop

specialty training at a post-masters level to provide the information and clinical

knowledge needed for music therapy work in a medical setting.

Recommendations for Future Research

This study has examined the effects of music therapy or music medicine on

patients receiving care in the ICU when compared to an attention control group. Both

music therapy and music medicine reduced anxiety scores from pre-session to post-

session, and pain scores for both groups decreased and remained below baseline at 60

minutes post session measurement. The changes in anxiety and pain scores over time do

suggest that both music therapy and music medicine can be effective. This does not
 105

support the hypothesis that music therapy may be more effective than music medicine in

addressing patient needs, but must be interpreted with caution due to the small sample

size and design concerns. The positive results across time for changes in respiratory rate,

anxiety levels and pain warrant further investigation with larger samples and perhaps

longer or more frequent exposure to music medicine or music therapy.

Dileo and Bradt (2005) reported a larger effect size for music therapy

interventions than for music medicine interventions. This would suggest that music

therapy is more effective than music medicine; however, current study data do not

support this assertion. Anxiety and pain scores were decreased by both treatments, and

music therapy participants had a shorter length of stay than attention control but not a

significantly shorter length of stay than music medicine. Based on the results of this

study, it appears that music therapy and music medicine have similar results for patients

in ICU. A study involving more equal-sized groups for music medicine and music

therapy may provide clearer information about the differences between the two

treatments, but this studys small number of participants in the music therapy group

makes it hard to draw any conclusions about the effectiveness of music therapy.

The current study data do not add to the music therapists arsenal of information

to advocate for the use of a music therapist in the ICU, when listening to CDs appears to

have similar benefits. But, there may be other things happening here. In this study it is

possible that the results of the two treatments were similar because they were both

provided by the music therapist who developed a relationship with the participants in

both groups. As the relationship between the music therapist and the client is a key factor
 106

in the music therapy process, it is difficult to conclude that music therapy and music

medicine were being independently investigated in this study. These results may more

accurately be understood as a comparison between music therapy and a control group.

From this perspective, there are significant differences between treatment and control for

anxiety and pain scores and length of stay. The use of a music therapist to assist ICU

patients in dealing with the stressors of the environment and the realities of critical illness

may include not only making music with and for the patient, but may also include

assisting the patient to explore and choose music for independent use when the therapist

is not available. This is a more involved process than a unit staff member who provides a

CD for patient listening because it is generically relaxing. A music therapist can assess

the patients needs and offer preferred music to address those needs within the context of

a musical relationship. A CD player and CDs on the unit can never offer that level of

individualized caring.

Reframing this study as a comparison of active music therapy using the decision

tree protocol vs. music therapy assisted independent relaxation provides increased

evidence of the effectiveness of these interventions for ICU patients.

Larger and longer studies need to be designed to examine cost-effectiveness data.

This small study showed a difference in length of stay for music therapy participants over

the attention control group, but it is much too small a sample for generalization. In

addition, use of medication, especially those ordered as needed, presents a major cost

for hospitals and a risk factor for potential error and adverse outcomes for patients. It

would be very informative to look at medication use before and after sessions.
 107

Ebneshahidi and Moshseni (2008) demonstrated a decrease in the use of pain medications

in response to music medicine in post-operative recovery.

Future research needs to be designed to allow music therapy to be provided by a

member of a research group who does not have multiple roles in the research process.

This would help to control for the potential biases created by the multiple roles and the

relationship built with all participants across groups during the informed consent and

baseline data collection phases of the research.

The music therapy profession has little evidence other than anecdotal to determine

the optimum length of a music therapy or music medicine intervention. How much

music therapy or music listening is the right amount and for which circumstances? How

often should the music be played or how often should a music therapy session be held?

When is the optimal time in the course of hospitalization to introduce music medicine or

music therapy?

The outcome measures being used in studies need to be evaluated. What impact

would it have on outcome data if mean arterial blood pressure was measured using an

arterial line rather than a blood pressure cuff? What frequency of sampling would be the

most useful and informative if this continuous monitoring of blood pressure were

available? With the rapidly changing technology available in medicine, it may be

possible now or in the near future to measure brain activity or blood chemistry that would

provide insights into the mechanisms of action involved in music making, music listening

or music therapy. It may be possible to investigate and understand the neural pathways

or stress response hormones being mediated by music therapy or music medicine

 108

interventions. Ressler (2010) writes of the exciting advances in neurophysiology,

molecular biology, behavior and neural circuitry that have taken place in the last few

years and posits that these will lead to preclinical and clinical studies to more clearly

define the links between neural circuits and behavior.

Music medicine has been researched extensively and provides us with indications

of how music listening can be beneficial to medical patients (Bradt & Dileo, 2009; Bradt,

Dileo & Grocke, 2010; Dileo & Bradt, 2005). Music therapy studies are rare, but Dileo

and Bradt (2005) did report a larger effect size for music therapy interventions than for

music medicine interventions. In the current study all positive outcome measures were

essentially equal for music therapy and music medicine. Much more music therapy

research remains to be done to clarify the effects of music therapy interventions when

compared with music medicine and to allow for the development of protocols for

effective evidence-based medical music therapy interventions.

 109

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APPENDIX A

REQUEST FOR PROTOCOL REVIEW

Study Title: Music Therapy vs. Music Medicine for Patients in Intensive Care

Part I. Characteristics of Potential Subjects

A. About how many subjects will you need?

175 subjects will be needed for this study

B. Describe the potential subjects in terms of gender, age range, ethnic group,

economic status, and any other significant descriptions.

Participants will be adult patients, ranging in age from 18 to 85 years.

C. Indicate any special subject characteristics, such as persons with mental

handicaps, prisoners, pregnant women, etc.

No participants will be included who meet the criteria for special subjects.

D. What is the general state of health of the subjects (physical and mental)?

Participants will be receiving medical care in the Intensive Care Unit of a

community hospital. While critically ill, they must be medically stable by nursing

assessment to be eligible to participate in this study.

E. Describe how you will gain access to these potential subjects.

Nursing staff on the Intensive Care Unit will identify potential participants based

on inclusion criteria (Medically stable, conscious and alert as determined by unit

nursing staff; able to communicate using gestures, mouthing, or speaking;

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adequate hearing to understand and hear music; English speaking; patients

between the ages of 18 85 years).

F. How will subjects be selected or excluded from the study?

Subjects will be excluded from the study for the following reasons:

Medically unstable patients, regardless of length of time in ICU; experiencing any

altered level of consciousness; unable to communicate via verbal or nonverbal

means, non-English speaking. on mechanical ventilation, hearing difficulties,

presence of dementia, patients younger than 18 years or older than 85 years

Any persons with special subject characteristics including mental handicaps,

prisoners or pregnant women.

G. If subjects are from an institution other than Temple University, please indicate

the name of the office responsible for granting access to subjects.

Office of Sponsored Research, The West Penn Allegheny Health System,

Pittsburgh, PA

H. If the subjects are children, anyone suffering from a known psychiatric condition,

or legally restricted, please explain why it is necessary to use these persons as

subjects.

The study will not include any children as all participants must be at least 18

years old.
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Part II. Experimental or Research Procedures

A. Please describe the intended experimental or research procedures. This should

include a description of what the subject will experience or be required to do.

Please attach a copy of all questionnaires or instruments to be used.

Purpose

The purpose of the study is to determine if there is an influence of music therapy

vs. music listening vs. attention control on physiological measures (heart rate,

blood pressure, oxygen saturation and respiratory rate), psychological measures

(anxiety and pain) and unit length of stay for Intensive Care Unit (ICU) patients.

Materials

The music therapist will have available a guitar, a small battery-operated

electronic keyboard, a battery-operated Sony CD player and CDs, and song title

lists for music therapy sessions. Music medicine (music listening) participants

will hear a sample CD (with five short samples of the music on the available CDs)

and receive a battery-operated Sony CD player and the chosen CD for listening.

The Attention Control Group will not receive any equipment.

Procedures

The study will be conducted with patients admitted to a closed Intensive Care

Unit. Prior to beginning the study, the researcher will hold in-service training

with the unit nursing staff to explain the study and the nurses role in making
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referrals. To identify potential participants, the researcher will meet with the unit

nursing staff to receive referrals of patients who meet inclusion criteria. The

researcher will be enrolled as Volunteer at the hospital to establish a relationship

to the institution to allow nurses to disclose the referrals for the study. The

researcher will visit all potential participants to provide an explanation of the

study. Potential participants will be asked to sign an Informed Consent form for

participation, including researcher access to medical records including HIPAA

requirements. This consent can be withdrawn at any time, and choosing to

withdraw from the study will have no influence on the delivery of medical care to

the ICU patient. Potential participants will be told that assignment to either

research group or the attention control group will be randomized.

Participants will be randomly assigned to either the music therapy treatment group,

the music listening group or the Attention Control group. After assignment to a

treatment condition or control, a music therapy or music listening session will be

scheduled in consultation with the unit nursing staff. The researcher will collect all

baseline data (Faces Anxiety Scale, Visual Analog Scale for Pain and music

questionnaire) requiring contact with the participant. A student research assistant

will record the baseline physiological data from the participants monitor at the

nursing station by printing a copy of the patients individualized data from the

screen. The participants name will be blackened and assigned number placed on

the printout. All post session data will be collected by a student research assistant

immediately following the session and at 60 minutes post session. A student

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research assistant (or more than one if needed to staff the hours of data collection)

will be recruited from local music therapy programs. Any student research

assistant will be required to complete research training as does any member of the

research team and will receive training in the administration of the FAS and VAS

and will be enrolled as a hospital volunteer.

Research conditions will be implemented as follows:

Music Therapy Sessions will be conducted according to a protocol using the

following format:

1. Opening or Warm-up. In addition to verbal discussion, the participant

will be asked to describe how music is a part of everyday life and what
music is meaningful/preferred/disliked.
2. Song choice participant chooses a song that the therapist will sing or
that the therapist and participant will sing. The song will be chosen
with the aim of helping the participant feel more comfortable (either
from a list provided, from the participants memory, or from options
suggested by the therapist in response to participant music preference
information)
3. Verbal discussion of the participants response to the song leading to
discussion of how participant is coping with the ICU experience.
4. Mobilizing coping skills (choice as clinically appropriate)
a. Choose a song that reflects feeling stronger or healthier which can be
sung (by therapist, by participant or together).
b. Create a song parody to describe coping skills which will be sung by
therapy, participant or both together.
c. Practice / learn relaxation technique (music assisted relaxation)
involving therapist chosen music and guided relaxation to assist the
participant in relaxing with the music.
5. Closure sing a final song or reinforce the relaxation technique with
reminders.

For the music listening group, the researcher will meet with the participant to

collect data for the demographic questionnaire and conduct the Faces Anxiety
 156

Scale and the Visual Analog Scale for Pain. A student research assistant will then

record the physiological measures just before the researcher enters the

participants room to deliver the music for listening. The participant will have the

opportunity to choose from among five different styles of music presented on a

sample CD including short excerpts of the five research CDs. The researcher will

assist the participant, playing the samples more than once if needed. Once the

participant selects his or her preferred music listening selection, the researcher

will place the CD into the player at the participants bedside and leave the room,

returning after 30 minutes to retrieve the music. The researcher will retrieve the

music without engaging in any discussion with the participant about the music,

except to let the participant know that the CD player is being removed. The

researcher may respond politely to participant-initiated comments and will record

these after leaving the room. A standardized script will be implemented with

participants in the music listening group. Immediately following the completion

of the music listening condition, a student research assistant will record the

physiological measures data, then visit the participant to repeat the FAS and VAS.

This same data will be collected again at 60 minutes post-session ending time. If

a participant is sleeping at the end of the music listening, he/she will not be

awakened for data collection. A second attempt will be made to conduct the FAS

and VAS at 30 minutes post-session but the participant will not be awakened if

still sleeping. The nurse manager of the unit reports it is unlikely participants will

not have been awakened by other medical personnel by 30 minutes post session
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and will surely have been awakened by 60 minutes. Participants sleep will not be

disturbed for the collection of study data.

The Attention Control Group participants will receive a befriending visit from

the researcher who will listen reflectively. If the participant prefers not to talk,

the researcher will sit quietly with the participant for 20 minutes. The researcher

will collect the music questionnaire information and conduct the FAS and VAS

prior to the befriending visit. A student research assistant will collect

physiological data immediately before the visit, immediately after the visit and at

the scheduled 60 minute post session interval. A student research assistant will

also conduct the repeated administrations of the FAS and VAS. No other contact

with the Attention Control Group is anticipated.

Statistical Analysis

Descriptive statistics will be calculated to examine means and correlations

between demographics and dependent variables. MANOVA will be used to

determine whether there are significant differences on the pretests and posttests of

the two experimental groups and the control group, and to determine whether

differences between pre-and posttests of the experimental groups (if any) are

significantly different than any differences found in the control group. Follow-up

multiple discriminant analysis (MDA) and related significance tests will then be

conducted to determine specific group differences

A power analysis using a software calculator G*Power (Faul, Erdfelder, Lang &

Buchner, 2007) indicates that with an expected moderate effect size (f = 0.25), p
 158

= 0.05 with power of .80 a total of 159 participants are needed to conduct

ANOVA analysis (Faul, et al., 2007). An effort will be made to recruit 175

participants to allow for attrition.

B. Will the subjects be deceived in any way? If yes, please describe below.

Subjects will not be deceived in any way.

C. To what extent will the routine activities of the subjects be interrupted during the

course of the study?

Music therapy will be an additional service to the standard care for intensive care

patients. In collaboration with the Nursing Unit Manager, plans are to conduct

the research conditions between afternoon and early evening visiting hours (2:30

pm 5 pm when less medical care is offered and participants will more likely be

available).

D. Indicate any compensation for subjects.

Participants will not be compensated for participation in the study.

Part III. Data Confidentiality

A. What procedures will you use to insure confidentiality of the data? How will you

preserve subject anonymity?

All data will be collected using an assigned number to protect the anonymity of

the participant. Data will be stored in a locked box kept on the medical unit

during the study or transferred to a locked file cabinet in the researchers office.

Access to the data will be limited to research team members. All data will be

retained for 3 years as required by DHHS

 159

Real names will not be used in any published materials nor will any identifying

information.

Part IV. Consent Procedures

A. Attach a copy of the consent form to be used. If non-written consent is to be used,

attach a statement describing exactly what the subjects will be told.

Informed Consent Form attached. Potential participants will be visited by the

researcher who will explain the study, give the participant time to read the

Informed Consent Form, answer any questions and review procedures. The

researcher will be careful to explain that declining the research will have no

impact on medical care and that even if potential participant consents, he/she is

free to withdraw from the study at any time. Participants will have the

opportunity to discuss the study with family or friends if desired and will be

revisited on the next research day if they choose not to consent on the day of

referral. A copy of the signed and dated Informed Consent Form will be provided

to each participant.

B. Describe how you will handle consent procedures for minors, mentally challenged
persons, and persons with significant emotional disturbances.

No minors or mentally challenged or significantly emotionally disturbed persons

will be included.

Part V. Benefits of the Study

A. How will any one subject benefit from participation in the study?
 160

Participants in the music therapy group will experience psychological support

from the researcher in her role as therapist; they will also receive validation for

their verbal and artistic expressions and the potential benefits of physiological

changes in response to the music. Participants may or may not experience a

reduction of anxiety or pain symptoms following the sessions.

Participants in the music listening condition will have the opportunity to rest and

relax with chosen music. This may lead to a reduction in anxiety or pain

symptoms and may serve to decrease the overall stress of hospitalization.

Attention control group participants will have received the benefit of having a

friendly visitor sit in the room with them for companionship and a listening ear, to

be used as they desire. No specific positive benefits can be promised to any

participant however, by participating in the study, subjects may experience less

stress in the ICU environment and may gain pleasure from knowing they are

contributing to knowledge that may be useful to future ICU patients.

B. How will society, in general, benefit from the conduct of the study?

This study offers the opportunity to collect specific data comparing the use of the

music therapy process with the use of music listening (often referred to as music

medicine in the literature). Meta-analysis of previous studies suggests that music

therapy has a greater effect on patient response but the number of studies in the

literature is very small. This data will add to our existing knowledge and may

offer guidance for future use of music therapy and music listening for ICU

patients.
 161

Part VI. Risks/Discomforts to Subjects

A. Describe any aspect of the research project that might cause discomfort,

inconvenience, or physical danger to the subjects.

Risks to participants are minimal. Inclusion/ exclusion criteria will screen

potential participants to assure that potential participants are medically stable.

There always exists the possibility that music will evoke an emotional response in

the listener that could stir discomfort. Music therapists are trained to recognize

and work with responses of this type and the researcher will respond with

clinically appropriate interventions as needed and disqualify any participant

requiring non-protocol intervention. Should the emotional response not be easily

resolved within the session time, the researcher will contact the participants nurse

for follow-up and referral to other hospital personnel as needed.

B. Describe any long-range risks to the subjects.

There are no anticipated long range risks associated with participation in this

study.

C. What is the rationale for exposing subjects to these risks?

As mentioned in section A and B there are no anticipated long range risks

associated with participation in this

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APPENDIX B

RESEARCH SUBJECT INFORMATION CONSENT FORM

Title: Music Therapy vs. Music Medicine for Patients in Intensive Care

Investigator: Michael M. Hansen, M.D., Western Pennsylvania Hospital, Forbes

Regional Campus, 2570 Haymaker Rd., Monroeville, PA 15146

Associate Investigator: Carol L. Shultis, M.Ed., LPC, MT-BC. Temple University

Graduate Student, 216 Alice Street, Pittsburgh, PA 15210

Study-related Phone number(s): Carol Shultis (412) 417-7390; Dr. Hansen (412)

858-2484.

This consent form explains the study. Please ask the study doctor, or the study staff to

explain any information that you do not clearly understand and/or to answer any

questions you have about the study. You will receive a copy of your signed consent form.

PURPOSE OF THE STUDY

You are being asked to take part in a research study the purpose of which is to study the effects of

music therapy and music listening for patients in intensive care. The information obtained in this

research study is important because knowing the effects of music on medical patients can enhance

future treatment for patients. You are being asked to join this research study because you are receiving

care in the ICU and meet the study criteria.

PROCEDURES

This study is an inpatient study which involves the participation of a maximum of 75 volunteers. You

are being asked to consent to participate in one approximately 25 minute session. Once you agree to

participate, you will be asked to complete a short questionnaire about your relationship to music. You

will be randomly assigned to receive either one music therapy session, one music listening session or

one visit from a friendly visitor. These sessions are designed to last about 25 minutes. Prior to your
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randomly assigned session and immediately after the session as well as 60 minutes after the session,

you will complete questionnaires about pain and anxiety. The researcher will help you to complete the

questionnaires before the session; a trained student research assistant will help you with the

questionnaires after your session. In addition, a student research assistant will be recording

physiological data from your routine monitoring available at the nursing station before and after your

session time. The researcher will also be collecting some basic information from your medical record

including your age, reason for admission to ICU, type of admission (emergency, post-op), your

gender, ethnicity and length of time you receive care in the ICU.

Participants assigned to the music therapy treatment session will be engaged in a music therapy

process which may include listening, singing, discussion, song writing and/or relaxation with music.

You may be asked to make decisions about some of the music used, to sing or listen to songs, discuss

the importance or meaning of those songs to you and explore coping skills.

Participants receiving the music listening condition will be asked to choose a CD for listening after

hearing five samples presented. You will receive a battery-operated CD player and CD placed in your

room at a scheduled time. You will listen to the music on your own. The CD and player will then be

retrieved by the researcher.

Participants receiving a friendly visitor will be visited by the researcher who will sit with you for 20

minutes. The researcher will listen if you wish to talk or will sit quietly with you. You may watch

TV, listen to your radio, take a nap, read or engage in whatever activity your wish.

RISK AND DISCOMFORTS

No physical risks are anticipated. For some people, hearing or engaging in music may cause

temporary emotional discomfort or distress. The researcher/music therapist will provide you with

support and assist you in managing these emotions. Should you need additional emotional support

beyond the session, you will be referred to another professional available for such intervention

through the hospital.

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Participants in the music listening and friendly visitor conditions are not likely to experience

emotional distress but if this occurs, you will be referred to the appropriate hospital staff.

There exists a risk that your confidentiality could be compromised. Every effort will be made to

protect your confidential information (see below) but you need to be aware that information could

unintentionally be accessed by someone beyond the research team.

BENEFITS

You will experience the benefits and pleasure of engaging in music therapy, listening to relaxing

music or of having a person sit with you and listen to your concerns. By participating in the study,

you may have the opportunity to receive an alternative therapy (non-pharmacological) that is not part

of standard ICU care which may reduce the stress of hospitalization and may reduce anxiety and pain.

Although specific benefits cannot be guaranteed, the information developed in this study may help

other medical professionals to clarify uses for music therapy and/or music listening for future patients.

COSTS

The research study activities required by the study will be provided at no cost to you.

PAYMENT FOR PARTICIPATION

You will receive no compensation for this study.

CONFIDENTIALITY

All documents and information pertaining to this research study will be kept confidential in

accordance with all applicable federal, state, and local laws and regulations. Study data will be

identified by number only and kept in a locked file box/cabinet. You understand that medical records

and data generated by the study may be reviewed by West Penn Allegheny Health System and/or

Temple University's Institutional Review Board and the Office for Human Subjects to assure proper

conduct of the study and compliance with federal regulations.

Research Study Authorization of Protected Health Information & HIPAA Authorization

In 1996 the government passed a law known as The Health Insurance Portability and Accountability

Act (HIPAA), Public Law 104-191. This privacy law, among other things, will improve how your
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health care information is protected and kept confidential when it is used or disclosed with others.

This includes your medical records and insurance information, as well as other personal health

information. This consent form describes to you how information about you may be used or disclosed

(released) if you are in a research study. It is important that you read this carefully.

In order to participate in this research study, you must permit (allow) certain research records to be

made about you in addition to the usual records the hospital and doctors create about your medical

treatment. These research records will contain private medical and other information, which is

protected by law. The researchers will only create the minimum amount of research records necessary

to carry out the research.

Types of research records that may be shared/copied are:

Medical Records: Specifically the length of time you are receiving care in the ICU, your age,

diagnosis, reason for admission, and type of admission (emergency, post-op). The researcher will also

be collecting records of your heart rate, blood pressure, oxygen levels and breathing rate from the

monitor in the ICU, as well as asking you about pain and anxiety and your experience with music.

In addition to using these research records to carry out the research and, perhaps, to treat you, the

researchers will share portions of these research records with the third parties involved in the research

study. The third parties, who receive research information, may further share the information about

you in accordance with their policies, practices, and what the law requires. However, some third

parties (such as the Sponsor) may not need to follow the privacy law. To the best of our knowledge, a

complete and accurate description of who the third parties are and how they will use or disclose the

information are as follows:

Third Party Purpose

West Penn Allegheny Health System May share this signed consent form and records

Allegheny-Singer Research Institute that identify you to meet regulatory

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WPAHS Compliance Office requirements or for purposes related to this

Department of Health & Human Services research.

Temple University

The release of information described above will be the minimum necessary to abide by the law,

complete the research, and perhaps, publish the research.

Unlike your medical records, you will not have access to research records made about you during the

study. However these will be available at the end of the study. Although every effort will be made to

keep research records about you private, complete confidentiality cannot be guaranteed. Such research

records may be subject to subpoena or court order. The researcher has set up safeguards to keep

private information about you confidential.

There is no expiration for this Authorization unless you revoke (cancel) it. You may revoke this

Authorization by writing to the Principal Investigator. If you revoke your Authorization, you will also

be removed from the study. Revoking your Authorization only affects the use and sharing of your

information after the written request is received. Any information obtained prior to receiving the

written request, may be used to maintain the integrity of the study (for example account for reporting

of side effects, sending information to the FDA for studies it regulates).

You can revoke your authorization by giving a written request with your signature to the principle

investigator.

Principal Investigator Name & Address:

Michael M. Hansen, M.D., Intensive Care Unit, 3rd Floor

Western Pennsylvania Hospital, Forbes Regional Campus,
2570 Haymaker Rd., Monroeville, PA 15146

If you choose to not sign this Authorization, you will not be permitted to participate in this research

study. In order to participate in this study, you must agree to the use and disclosure of your

information with the groups above. Upon completion of the study or if you withdraw from the study
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at any time, the research records about you will be kept by the researcher(s) and all of the information

provided above will continue to apply to your research records.

VOLUNTARY PARTICIPATION AND WITHDRAWAL

Your participation in this study is entirely voluntary. Choosing not to participate is without penalty

and will not result in any loss of benefits to which you are otherwise entitled. Should you wish to

discuss your consent to participate with a family member or friend, you may do so and give your answer

on the next research day. Please feel free to ask as many questions as you need to understand the purpose

of the research and what you can expect if you participate. Do not sign this consent form unless you have

had a chance to ask questions and have received satisfactory answers to all of your questions.

If you agree to participate in this study, you will receive a signed and dated copy of this consent form for

your records.

ATLTERNATIVE TO PARTICIPATION

You may choose not to participate in this study. You will continue to receive all medical care to which

you are otherwise entitled. Choosing not to participate has no negative outcomes.

TERMINATION OF PARTICIPATION

You may choose to withdraw from this study at any time. In order to do so, you need only to tell the

researcher. Your participation may be terminated at any time by the ICU medical staff or the Principal

Investigator without your consent.

NEW INFORMATION

You will be informed of new information, both good and bad, that develops during the course of this

study so that you can consider whether to continue your participation.

QUESTIONS

If you have any questions concerning your participation in this study or if at any time you feel you have

experienced a research-related problem, contact: The ASRI-WPAHS Institutional Review Board, 4800

Friendship Avenue, Pittsburgh, PA 15224 (412) 578-5896

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CONSENT

If you would like further information about this study, please contact us.

Carol Shultis (412) 417-7390; Dr. Hansen (412) 858-2484.

Signature__________________________________________ Date _____________

Participant

Signature__________________________________________ Date____________

Researcher

This consent was revised in July, 2011 and an additional signature line for a witness was

added as well as an additional column for time of day following date at the request of the

WPAHS IRB.
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APPENDIX C

DEMOGRAPHIC/MUSIC QUESTIONNAIRE

Western Pennsylvania Hospital Forbes Regional Campus

Music Therapy / Music Listening Study

Demographic Data

Study Participant No. _______ Date _____________ Age ____

Gender _____ Ethnicity ____________ Education level ______

Reason for admission to ICU __________________________________________

Type of admission (planned post-op vs. emergency) ______________________

Length of stay in ICU as of this date ____________________________________

Music History/Information

Previous use of music as a stress management tool? Yes ____ No ____

Previous experience with music therapy? Yes ____ No ____

Importance of music in everyday life? (Scale of 1-9 1 = no importance, 9 = vital) ____

Music preferences?

Specific styles/genres

Classical _____ Pop _____ Jazz _____ Sacred _____

Easy listening _____ Rock ____ Big Band _____ Folk ____

Country _____ New Age ____ Solo instrument ____(Specify) ____

Previous experience as a musician? Yes ____ What? ___________________ No ____

Play any instruments? Yes _____ (specify) __________________________ No ____

Any musical sounds you do not like to hear? If Yes, specify ________________No ____
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APPENDIX D

MUSIC THERAPY GROUP PARTICIPANT SONG LYRICS

All lyrics were written and given to participants to keep.

Original Blues Tune - lyrics not kept. March 23, 2011

Song dealt with family and memories of childhood ending with a message to Dad

And I just wanna say, I love you.

To the tune of You Are My Sunshine May 4, 2011

Back in the hospital for the last time, Theyll figure out why my BP is high,

Listening and following just what they say, Dealing with my medical cares.

Back to my life, I know Ill be happy, Visiting my grandchildren as oft as I can,

Having more energy with my BP controlled, Thats what my lifes gonna be.