Professional Documents
Culture Documents
DOI 10.1007/s11136-017-1525-5
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Vol.:(0123456789)
1820 Qual Life Res (2017) 26:1819–1829
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Qual Life Res (2017) 26:1819–1829 1821
the moderate correlation between the VAS-A and the STAI, Interventions
we considered that it is acceptable because we assumed
that they measured different aspects of the anxiety. In addi- A caution note—“Do not disturb during the period of
tion, the correlation between the VAS-A and the STAI music intervention”—was posted outside the room of all
was higher than the correlation between the VAS-A and a participants whether he/she was in either group. Neither
depression measure, Patient Health Questionnaire (r = 0.30; routine care nor visitors were permitted during the inter-
Fisher’s r-to-Z = 3.32; p < 0.01) [24]. Also, the responsive- vention period (or the resting period in the Control group).
ness of the VAS-A has been supported: The VAS-A can A research nurse—who was unfamiliar to the patients in
detect changes in anxiety via a significant pre- to during- either group—also silently sat at the bedside to care for the
stressor in VAS-A scores (F [1, 48] = 25.13, p < 0.001) patients’ physical needs when necessary. In addition, light
[24]. Therefore, we concluded that using VAS-A as one of and temperature were set up in the same conditions for all
our primary measures was acceptable. groups.
The C-STAI includes state and trait anxiety; only state
anxiety was used in this study. The state anxiety consists of Music intervention
20 items; each item was rated on a 4-point Likert scale with
a lower score representing a lower level of anxiety. The A 30-min session for each participant to listen to music was
state anxiety of C-STAI had adequate reliability (α = 0.90), provided in the Music group between 4:00 and 4:30 PM.
test–retest reliability (r = 0.74), and concurrent validity [28, Patients were not given other treatments for their illnesses
29]. Moreover, α values of the C-STAI were satisfactory in during the music intervention session. The following music
our study (α = 0.83 for the baseline measure, 0.78 for the programs were provided for participants to select one for
post-test measure). intervention according to their preference [11, 14]: West-
ern classical music (e.g., Erik Satie’s Trios Gymnope‑
Secondary endpoint: blood pressure, heart rate, dies, Mozart’s Piano Concerto no. 26), Chinese classical
and breathing rate music (e.g., bamboo flute, rain, and tears), music of natu-
ral sounds (e.g., Sylvan Spa [31]; Relax Your Mood [32]),
We used an HP/Philips/Agilent M1205A system, which and religious music, including Buddhist [33] and Christian
was calibrated twice per year, to automatically monitor [34].
and record blood pressure, heart rate, and breathing rate. In The characteristics of the music included a slow beat
addition to the commonly used systolic and diastolic blood (60–80 beats per minute) corresponding to a normal heart
pressures (SBP and DBP), we used mean arterial pressure rate, which helped the patients relax [35]. We used an
(MAP) to demonstrate overall blood pressure. MP3 player placed at the patient’s bedside and delivered
the music through headphones. During the intervention,
Justification for sample size all participants lay on a bed with the lights low and room
temperature set at 26 °C, and were free to ask the research
G*Power 3.1.5 [30] was used to estimate the sample size nurse to help them adjust the volume.
with the effect size of Cohen’s d at 0.8 on a two-tailed inde-
pendent t test. In addition, the following default setups were Aromatherapy
used for sample estimation: a type I error of 0.05, an alloca-
tion ratio of 1 for the two groups, and a power of 0.95. We The day before receiving aromatherapy, a research nurse
used an effect size at 0.8 because Han et al. [12] reported placed one drop of lavender essential oil on the medial
a large effect size (their Cohen’s d was ca. 1.67) and Lee forearm of participants assigned to the Aromatherapy
et al. [14] reported a small effect size (their Cohen’s d group, and observed the reaction of the participants’ skin
was ca. 0.04) between their music intervention and con- for the following 20 min. The nurse declined participa-
trol groups. Using the effect size at 0.8, which is between tion of those who had uncomfortable feelings (e.g., red or
the two, seemed appropriate. Also, Wu et al. [20] reported itchy). Finally, all participants in the Aromatherapy group
an effect size similar to 0.8 (their Cohen’s d was ca. 0.73) did not have uncomfortable feelings. Although five par-
between aromatherapy and control groups. The estimated ticipants declined to participate, they declined because of
sample size for each group was 42 with a total of 126. We family issues instead of uncomfortable feelings. On the day
assumed that 20% of the patients would decline to par- of receiving aromatherapy, a research nurse who had com-
ticipate or drop-out; therefore, we invited 160 patients to pleted the training of aromatherapy massage let the partici-
participate, and finally had 132 retained in our study. The pant recline in a lateral position. Then she placed the car-
number of retained participants suggested our sample size rier oil on the participant’s four limbs and entire back of the
was acceptable. participant, followed by applying 2% lavender essential oil
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1822 Qual Life Res (2017) 26:1819–1829
(20 cc; dōTERRA), and massaged the participant’s back of allocation concealment was accounted for when we used
the participant using the technique of stroking for 5 min. the RANDBETWEEN function. We did not generate all
Afterward, the research nurse positioned the participant in the random numbers in advance, but only when an eligi-
a supine position for 5 min. The participant was then laid ble participant was enrolled. Hence, we did not know in
on a bed in any preferred position for the rest of 20 min advance which treatment the next person would get. After-
with the lights low and the room temperature set at 26 °C. ward, the head nurses explained the study purpose to eligi-
ble ICU patients and asked for a signed informed consent
Control group from those willing to participate. Originally, 56 patients
were invited into the Music group and 52 into the Aroma-
Participants in the control group had a 30-min rest between therapy and Control groups each. However, 15 patients in
4:00 and 4:30 PM, the same time that the intervention the Music group declined to participate or dropped out; 5
groups were listening to their music intervention or receiv- in the Aromatherapy group declined to participate; 8 in the
ing their aromatherapy. Control group dropped out. Therefore, 132 patients pro-
vided signed informed consent (Fig. 1).
Procedures The measures for primary endpoint were collected at
4:00 PM (before intervention) for baseline measures and
ICU head nurses first identified the eligible patients at 4:30 PM (after intervention) for post-test measures.
(n = 160), and then, one research nurse randomized the Blood pressure, heart rate, and breathing rate were moni-
eligible patients into three groups with the allocation ratio tored from 4:00 to 5:00 PM, and we measured the values
as 1. Excel was used to generate the random number for every 10 min (e.g., 4:00, 4:10, 4:20). The baseline data
assigning eligible patients into the experimental or control and post-test data were collected just before and after the
group. Specifically, we used the RANDBETWEEN func- intervention, respectively. In addition, two trained research
tion with numbers between one and three. A random num- nurses—blinded to the research purposes based on stand-
ber of one was assigned to the Control group, of two to the ardized procedures—took blood samples, measured the
Music group, and of three to the Aromatherapy group. The C-STAI, VAS-A, and recorded the blood pressure, heart
Randomization
Pretest measure
VAS-A, C-STAI, HR, RR, SBP, DBP, MAP
Posttest measure
VAS-A, C-STAI, HR, RR, SBP, DBP, MAP
Fig. 1 Flow diagram of the study. VAS-A visual analogue scale-anxiety, C-STAI State-Trait Anxiety Inventory-Chinese version, HR heart rate,
RR respiratory rate, SBP systolic blood pressure, DBP diastolic blood pressure, MAP mean arterial pressure
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Qual Life Res (2017) 26:1819–1829 1823
rate, and breathing rate of all participants. The study lasted Results
from August 2013 through December 2014.
Participant characteristics
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1824 Qual Life Res (2017) 26:1819–1829
p = 0.03), lower SBP (mean difference = −4.98, p < 0.001), ICU patients. Our study seems to be the first to compare
and lower MAP (mean difference = −2.13, p = 0.001). the effects between music intervention and aromatherapy in
an ICU population. Generally speaking, if we focused on
GEE results the immediate post-treatment effects, our results showed
that both music intervention and aromatherapy had effects
GEEs corroborated data presented in Fig. 2, suggesting that on reducing anxiety but on different levels—the effect of
the Aromatherapy group had a longer duration of effect music intervention seemed to be stronger than that of
than the Music group. For the Music group, all significant aromatherapy.
and positive interactions were found before the end of the The effects of our music intervention agree with pre-
intervention: 20 and 30 min for heart rate [B (SE) = 2.95 vious findings [12, 36] that self-reported C-STAI scores
(0.63) and 2.85 (0.79), p < 0.001), SBP [B (SE) = 2.98 decreased, and with those studies in which blood pressure
(0.91) and 2.45 (0.99), p = 0.001 and 0.013]; 20 min for and heart rate were decreased [4, 14]. In contrast, Cooke
MAP [B (SE) = 1.26 (0.50), p = 0.012]. In contrast, the Aro- et al. [1] did not find the effectiveness of music intervention
matherapy group had significant and positive interactions at using the Faces Anxiety Scale; however, it has been pro-
10–20 min after the end of the intervention. Specifically, posed that the shorter treatment session (15 min vs. 30 min)
significant interactions were found at 40 and 50 min after may explain this result [6]. In addition to the immediate
baseline measure for heart rate [B (SE) = 4.13 (0.54) and effects after music intervention, our results found that the
1.79 (0.53), p = 0.001], SBP [B (SE) = 4.34 (0.76) and 2.94 effects can last for at least 30 min, though we had only
(0.78), p < 0.001], and MAP [B (SE) = 2.37 (0.55) and 2.22 physiological parameters to support the effects.
(0.52), p < 0.001] (Table 3). Our results also portrayed the effects of aromatherapy
on reducing anxiety for ICU patients though the effects
seemed less promising than that of the music interven-
Discussion tion. Nevertheless, our findings agree with the effects of
aromatherapy found in ICU patients [21, 37]. Karaman
Because little is known about the follow-up effects of et al. [21] showed the effects using Beck Anxiety Inven-
music and aromatherapy interventions on reducing anxi- tory, and Cho et al. [37] and we demonstrated the imme-
ety for ICU patients, we wanted to investigate whether the diate effects of anxiety reduction in VAS-A score and
reducing effects could last for a certain period of time. We showed the effects in heart rate. Our results of the effect
also intended to explore the effects of aromatherapy on shown by VAS-A is consistent with the results of Braden
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Baseline measurea
VAS-A (mm) 57.20 (9.22) 56.38 (9.19) 57.95 (8.24) −0.76 (−4.53, 3.01; −1.57 (−5.22, 2.07; 0.81 (−3.10, 4.72;
0.69) 0.39) 0.68)
C-STAI (Likert 2.78 (0.23) 2.79 (0.21) 2.79 (0.19) −0.01 (−0.10, 0.08; −0.002 (−0.09, 0.08; −0.01 (−0.10, 0.08;
scale) 0.79) 0.96) 0.84)
Heart rate (beats/ 80.22 (8.40) 77.47 (5.92) 79.34 (7.65) 0.88 (−2.58, 4.34; −1.87 (−4.71, 0.97; 2.75 (−0.30, 5.80;
minute) 0.62) 0.19) 0.08)
Breathing rate 15.44 (2.06) 15.64 (2.11) 15.34 (2.80) 0.10 (−0.97, 1.16; 0.30 (−0.73, 1.33; −0.20 (−1.09, 0.69;
(times/minute) 0.86) 0.57) 0.66)
SBP (mmHg) 125.76 (14.56) 124.00 (13.07) 123.75 (15.42) 2.01 (−4.48, 8.49; 0.25 (−5.69, 6.19; 1.76 (−4.10, 7.61;
0.54) 0.93) 0.55)
DBP (mmHg) 62.66 (6.77) 64.53 (7.74) 63.70 (8.17) −1.05 (−4.30, 2.20; 0.83 (−2.49, 4.14; −1.87 (−4.98, 1.23;
0.52) 0.62) 0.23)
MAP 83.69 (8.32) 84.35 (9.01) 83.72 (9.66) −0.03 (−3.93, 3.87; 0.64 (−3.25, 4.52; −0.66 (−4.36, 3.03;
0.99) 0.75) 0.72)
Post-test measureb
VAS-A (mm) 49.56 (8.09) 52.81 (8.34) 55.94 (9.27) −6.38 (−9.05, −3.71; −3.13 (−5.80, −3.25 (−5.90, −0.59;
<0.001) −0.46; 0.015) 0.011)
C-STAI (Likert 2.62 (0.23) 2.67 (0.19) 2.71 (0.18) −0.10 (−0.17, −0.03; −0.05 (−0.11, 0.02; −0.05 (−0.12, 0.01;
scale) 0.001) 0.27) 0.17)
Heart rate (beats/ 75.53 (9.98) 77.01 (6.24) 79.71 (8.15) −4.18 (−5.98, −2.39; −2.70 (−4.51, −1.48 (−3.28, 0.32;
minute) <0.001) −0.90; 0.001) 0.15)
Breathing rate 15.39 (2.48) 15.48 (2.37) 15.98 (2.99) −0.59 (−1.30, 0.12; −0.50 (−1.21, 0.21; −0.09 (−0.79, 0.62;
(times/minute) 0.14) 0.26) 1.00)
SBP (mmHg) 122.06 (14.49) 125.21 (12.84) 126.16 (14.19) −4.10 (−5.81, −2.39; −0.94 (−2.65, 0.76; −3.15 (−4.85, −1.46;
<0.001) 0.54) <0.001)
DBP (mmHg) 63.77 (7.20) 63.07 (7.36) 63.45 (8.22) 0.32 (−1.07, 1.72; −0.38 (−1.77, 1.01; 0.71 (0.68, 2.09; 0.66)
1.00) 1.00)
MAP (mmHg) 83.20 (8.57) 83.78 (8.55) 84.35 (9.13) −1.15 (−2.22, −0.85; −0.57 (−1.64, 0.49; −0.58 (−1.64, 0.48;
0.03) 0.58) 0.56)
VAS-A visual analogue scale-anxiety, C-STAI State-Trait Anxiety Inventory-Chinese version, SBP systolic blood pressure, DBP diastolic blood
pressure, MAP mean arterial pressure
a
Analysis of variance (ANOVA) was used to analyze each baseline measure, and a total of 7 ANOVAs were performed
b
Analysis of covariance (ANCOVA) adjusted for age, sex, and baseline measures was used to analyze each post-test measure, and a total of 7
ANCOVAs were performed. The post-test measure was measured at after receiving 30 min of interventions
c
With Bonferroni adjustment
et al. [15], who also used the VAS-A to measure anxiety of lavender essential oil and found that ICU patients
and lavender essential oil for aromatherapy. The lack of reduced their anxiety using the Beck Anxiety Inventory.
significant difference in C-STAI anxiety scores between An interesting finding is that music intervention had
aromatherapy and control patients contradicts the find- stronger effect than the aromatherapy at the post-test
ings of Ni et al. [18]. A possible explanation may lie in measure; however, as we followed the effects of reducing
the difference between essential oils used with our aro- anxiety, the heart rate and blood pressure of the Aroma-
matherapy participants receiving lavender essential oil, therapy group kept decreasing, while those of the Music
while Ni et al. [18] used bergamot essential oil. That is, group were maintained. Finally, the Aromatherapy group
different types of essential oils may have different treat- had lower heart rate and blood pressure compared with
ment effects; however, future studies are needed to fur- the Music group at the end of the data collection (i.e.,
ther probe this issue. Another possible explanation for the 60 min after the beginning of the interventions). We
non-significant effects shown in our C-STAI score is the speculate that perhaps the effects of aromatherapy were
intervention duration: Karadag et al. [21] applied 15 days delayed because the Aromatherapy group needed more
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Fig. 2 Trends of heart rate, breathing rate, and blood pressure every 10 min. Intervention (i.e., music intervention and aromatherapy) was began
after pre-test and ended at 30-min
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Qual Life Res (2017) 26:1819–1829 1827
time than the Music group to absorb the effects. That Limitations
is, the music can be directly input into an individual’s
mind; the essential oil needs time to be absorbed into the There are some limitations in the study. First, our rand-
skin. However, we did not have additional evidence to omized controlled trial design was not robust because we
support our speculation, and future studies are encour- did not use a placebo as a control for aromatherapy. How-
aged to investigate the potential mechanisms. ever, we justified that using placebo is somewhat difficult.
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The frequently used placebo for aromatherapy is water therefore suggest that clinical nurses should learn the tech-
[18, 22]; however, patients can easily detect whether they nique and apply it when necessary.
received aromatherapy or placebo due to the smell. There-
fore, it seems hard for us to eliminate the placebo effects
of aromatherapy. Second, the choices for music interven- Conclusion
tion and aromatherapy were restricted (only four types of
music for the Music group, and only lavender essential Among mechanically ventilated ICU patients, both a music
oil for the Aromatherapy group). Therefore, patients may intervention and aromatherapy can reduce anxiety and the
not have chosen their most preferable music or oil, and the effects can last for up to 30 min after cessation of treat-
effect of music intervention and that of aromatherapy might ment. Clinicians in critical care may apply both treatments
have been diminished. Third, all participants were recruited as an alternative to drugs.
from the same hospital, and the generalizability of our
results might be restricted because the participants might Acknowledgements We thank the directors, head nurses, and
share similar demographic characteristics. Fourth, partici- research nurses in the ICU of Chung Shan Medical University Hos-
pants in the Control group may have had increased anxiety pital for their assistance, and Ms. Bei-Yu Chiang and Chang-Si Wang
for advice on selecting music. Without their help, we could not have
because they wore a noise-canceling headphone; however, finished this study.
we tried to diminish the effects using statistical methods
(i.e., ANCOVA that accounts for possible confounders). Compliance with ethical standards
Fifth, although the follow-up effects of music interven-
tion and aromatherapy were supported by physiological Conflict of interest The authors declare that they have no conflict
parameters, we did not know whether the subjective meas- of interest.
ures have similar effects because both VAS-A and C-STAI Ethical approval All procedures performed in studies involving
were conducted before and immediately after treatment. human participants were in accordance with the ethical standards of
Sixth, we randomly assigned the eligible patients into dif- the institutional and/or national research committee and with the 1964
ferent groups before seeking their consent to participate. Helsinki declaration and its later amendments or comparable ethical
standards.
This approach could lead to an unbalanced sample size
between groups, and result in insufficient statistical power.
Informed consent Informed consent was obtained from all individ-
Fortunately, our sample sizes were nearly equal among the ual participants included in the study.
three groups; thus, the limitation did not seriously influence
our results. Finally, although we provided the information
of psychometric properties for both the VAS-A and the
C-STAI based on previous studies, it should be cautioned References
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