The Effect of CaregiverFacilitated Pain Management Interventions in Hospitalized Patients On Patient Caregiver Provider and Health System Outcomes A Systematic Review

1034 Journal of Pain and Symptom Management Vol. 60 No.
5 November 2020
Review Article
The Effect of Caregiver-Facilitated Pain Management

Interventions in Hospitalized Patients on Patient, Caregiver,
Provider, and Health System Outcomes: A Systematic
Review
Israt Yasmeen, MBT, Karla D. Krewulak, PhD, Cherri Zhang, MHSc, Henry T. Stelfox, MD, PhD, and
Kirsten M. Fiest, PhD
Department of Critical Care Medicine (I.Y., K.D.K., C.Z., H.T.S., K.M.F.), Alberta Health Services & Cumming School of Medicine,
University of Calgary, Calgary, Alberta; Department of Community Health Sciences & O’Brien Institute for Public Health (H.T.S., K.M.F.),
University of Calgary, Calgary, Alberta; and Department of Psychiatry & Hotchkiss Brain Institute (K.M.F.), Cumming School of Medicine,
University of Calgary, Calgary, Alberta, Canada
Abstract
Context. Alternative pain management interventions involving caregivers may be valuable adjuncts to conventional pain
management interventions.
Objectives. Use systematic review methodology to examine caregiver-facilitated pain management interventions in a
hospital setting and whether they improve patient, caregiver, provider, or health system outcomes.
Methods. We searched MEDLINE, EMBASE, PsycINFO, CINAHL, and Scopus databases from inception to April 2020.
Original research on caregiver-facilitated pain management interventions in hospitalized settings (i.e., any age) were included
and categorized into three caregiver engagement strategies: inform (e.g., pain education), activate (e.g., prompt caregiver
action), and collaborate (encourage caregiver’s interaction with providers).
Results. Of 61 included studies, most investigated premature (n ¼ 27 of 61; 44.3%) and full-term neonates (n ¼ 19 of 61;
31.1%). Interventions were classified as activate (n ¼ 46 of 61; 75.4%), inform-activate-collaborate (n ¼ 6 of 61; 9.8%), inform-
activate (n ¼ 5 of 61; 8.2%), activate-collaborate (n ¼ 3 of 61; 4.9%), or inform (n ¼ 1 of 61; 1.6%) caregiver engagement
strategies. Interventions that included an activate engagement strategy improved pain outcomes in adults (18e64 years) (e.g.,
self-reported pain, n ¼ 4 of 5; 80%) and neonates (e.g., crying, n ¼ 32 of 41; 73.0%) but not children or older adults (65 years
and older). Caregiver outcomes (e.g., pain knowledge) were improved by inform-activate engagement strategies (n ¼ 3 of 3).
Interventions did not improve provider (e.g., satisfaction) or health system (e.g., hospital length of stay) outcomes. Most
studies were of low (n ¼ 36 of 61; 59.0%) risk of bias.
Conclusion. Caregiver-facilitated pain management interventions using an activate engagement strategy may be effective in
reducing pain of hospitalized neonates. Caregiver-facilitated pain management interventions improved pain outcomes in
most adult studies; however, the number of studies of adults is small warranting caution pending further studies. J Pain
Symptom Manage 2020;60:1034e1046. Ó 2020 The Authors. Published by Elsevier Inc. on behalf of American Academy of Hospice and
Palliative Medicine. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Key Words
Neonate, pain, hospital, caregivers, family, systematic review
Address correspondence to: Kirsten M. Fiest, PhD, Department Accepted for publication: June 23, 2020.
of Critical Care Medicine, Ground Floor, McCaig Tower,
3134 Hospital Drive Northwest, Calgary, Alberta, Canada
T2N 5A1. E-mail: kmfiest@ucalgary.ca
Ó 2020 The Authors. Published by Elsevier Inc. on behalf of 0885-3924/$ - see front matter
American Academy of Hospice and Palliative Medicine. This is an https://doi.org/10.1016/j.jpainsymman.2020.06.030
open access article under the CC BY-NC-ND license (http://
creativecommons.org/licenses/by-nc-nd/4.0/).
Downloaded for RAVIKIRAN SURYANARAYANAMURTHY (ravikiran.s@sakraworldhospital.com) at ClinicalKey Global Guest Users from
ClinicalKey.com by Elsevier on December 11, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights
reserved.
Vol. 60 No. 5 November 2020 Caregiver-Mediated Pain Management in Hospitalized Patients 1035
Background (OVID), PsycINFO (ProQUEST), CINAHL (EBSCO),

Pain, defined as an unpleasant sensory and and Scopus (Elsevier) were searched from inception
emotional experience associated with actual or poten- to April 14, 2020. The search criteria included subject
tial tissue damage,1 affects 30%e77% of hospitalized headings, keywords, and Boolean logic for caregivers;
adults2e7 and is also common in hospitalized pediatric intervention; pain; and hospital (Appendix I). A care-
patients (i.e., neonates, children).8e12 Inadequate giver was defined as a family member, relative, friend,
pain management is associated with increased postop- or paid helper external to the hospital health care
erative complications, extended duration of recovery, team who regularly looks after the patient (excluding
longer hospital stays, unnecessary readmissions, nega- volunteers and health or social workers). There were
tive long-term effects on development for neonates, no limitations placed on the age of included patients
and increased health care costs.13e16 Despite the or year/language of publication.
high prevalence of pain and its associated negative
outcomes, pain management in patients of all ages is Study Selection
suboptimal in hospitals.5,8,9,12,17e19 Inadequate pain Two human reviewers (I. Y., C. Z., or K. D. K.)
management in pediatric and adult patients may be screened all titles and abstracts. The DistillerAI soft-
due to physicians’ negative perceptions about anal- ware toolkit (a component of DistillerSR; Evidence
gesic therapy, patient/caregiver fear of developing Partners, Ottawa, Canada) was a second reviewer for
addiction to analgesics, and a lack of patient/caregiver title and abstract screening. The DistillerAI toolkit
awareness of analgesic side effects.20,21 used a naive Bayes classifier, a Support Vector Machine
The American Pain Society guidelines recommend classifier, or both to train on a subset of human
involving patients and caregivers in pain management, screened references. It then scored references in
such as providing them information about available terms of their likelihood for inclusion. Screening deci-
pain control options and encouraging collaborative sions were made by applying a threshold for inclusion
and realistic goal setting with their physicians.22 The to the calculated scores for each reference. References
guidelines also recommend documenting pain educa- included by any reviewer (human or DistillerAI) pro-
tion for patients and caregivers as a method to ceeded to the full-text screening stage. Two human re-
monitor quality indicators for pain management.22 viewers (C. Z., I. Y., or K. D. K.), not DistillerAI,
Involving caregivers in pain management of pediatric screened references at the full-text stage. References
and adult patients is feasible because caregivers know included by both reviewers were included in the final
the patient best and may identify individualistic pa- sample. Any disagreements between the two reviewers
tient pain behaviors, such as muscle tension, facial ex- were resolved by discussion or by a third reviewer (K.
pressions (e.g., reddening of the face), and body M. F.). Refer to Appendix II for a detailed description
movements (e.g., restlessness).23,24 Adult intensive of DistillerAI.
care unit (ICU) patients’ self-reported pain was closer
in agreement with caregivers’ ratings compared with Data Extraction and Quality Analysis
ratings by nurses and physicians.25 Including care- Data were abstracted independently by one author
givers in pain management may reduce pain by (I. Y.) and verified by a second author (C. Z.). Study
increasing patient adherence to pain treatment,26 characteristics (e.g., study design, setting), participant
which may then improve caregiver and provider well- demographics, and descriptions of the intervention
being,27 and benefit the health system by reducing and control groups were recorded. Included non-
hospital stay.28 The goal of this systematic review was English articles (n ¼ 5; three Persian, one Spanish,
to evaluate whether caregiver-facilitated pain manage- and one Turkish) were translated using Google Trans-
ment interventions in hospitalized patients of all ages late (http://translate.google.com), which is an accu-
were effective in improving patient, caregiver, pro- rate tool for translating non-English articles in
vider, or health system outcomes. systematic reviews.30
Risk of bias (ROB) was assessed as high, low, or un-
clear by two independent reviewers (I. Y. and C. Z. or
K. D. K.) using the Cochrane Collaboration’s ROB
Methods tool.31 The strength of evidence was assessed using
Data Sources and Searches the Grading of Recommendations Assessment Devel-
This systematic review was conducted following the opment and Evaluation working group approach,32
Preferred Reporting Items for Systematic Reviews which initially ranks randomized controlled trials
and Meta-Analyses criteria29 (Fig. 1). The protocol (RCTs) high and observational studies low, with
was published a priori on PROSPERO (ID: studies downgraded or upgraded based on methodo-
CRD42018087248). MEDLINE (OVID), EMBASE logical quality and quality of evidence. We gave an
reserved.
1036 Yasmeen et al. Vol. 60 No. 5 November 2020
overall rank (high, moderate, or low) based on the encourage caregivers to engage with providers or
Grading of Recommendations Assessment Develop- other caregivers33 (Appendix III). Patients were classi-
ment and Evaluation working group criteria.32 fied as premature neonates if their gestational age was
less than 37 weeks34 and full-term neonates (37þ
weeks gestational age through 28 completed days of
Data Synthesis and Analysis
life).35 Neonates were divided into premature and
Data were grouped and summarized using STATA
full-term neonates because of differences in their
(StataCorp, College Station, TX). Meta-analysis was
physiology.36 Children were patients younger than
not conducted because of the heterogeneity of re-
18 years, adult patients were those between 18 and
ported interventions, participant populations, and
64 years, and older adults were those identified as
outcomes. A standardized effect size of the included
such or if the mean age of participants was greater
interventions was not calculated because of inconsis-
than or equal to 65 years (or based on the authors’
tent reporting or missing information (e.g., no SD)
definition). Outcomes were classified as patient (e.g.,
and heterogeneity of studies (e.g., different pain
pain, crying, change in heart rate), caregiver (e.g.,
scales). Interventions were characterized by three
anxiety, depression, stress), provider (e.g., satisfaction,
caregiver engagement strategies based on a
anxiety), or health system (e.g., length of hospital stay,
caregiver-facilitated knowledge translation framework
use of the health care system).
developed for patients of all ages:33 inform interven-
tions that educate caregivers on patients’ disease con-
dition, treatment, or management; activate Role of the Funding Source
interventions that prompt caregivers to participate in The funding source had no role in study design,
patient care; and collaborate interventions that analysis, or writing of this manuscript.
Identification
Records identified through Additional records identified

database searching through other sources
(n = 18,203) (n = 43)
Records after duplicates removed

(n = 13,902)
Screening
Records screened Records excluded

(n = 13,902) (n = 13,658)
Full-text articles assessed Full-text articles excluded (n = 183)

for eligibility
Eligibility
(n = 244) Intervention not related to pain

management (n = 29)
Intervention not mediated by a
caregiver (n = 50)
Studies included in Not in hospitalized patients
qualitative synthesis (n = 38)
(n = 61) Not an interventional study
(n = 25)
Not original research (n = 13)
Included
Ineligible study design (e.g.,

abstract, protocol, dissertation)
(n = 18)
Does not include a comparison
group (n = 8)
Does not include patient,
caregiver, provider, or health
system outcomes (n = 2)
Fig. 1. Preferred Reporting Items for Systematic Reviews and Meta-Analysis flowchart to identify reviewed and included
articles.
reserved.
Results breastfeeding (n ¼ 7 of 46; 15.2%)46,51,58,60,82,84,95

Study Characteristics and facilitated tucking, where parents position the
After screening 13,902 titles and abstracts, 61 preterm neonate in a flexed position (n ¼ 3 of 46;
studies were included (Fig. 1).37e97 Studies were pub- 6.5%).38e40 Few (n ¼ 2 of 7; 28.6%)41,75 interventions
lished between 1979 and 2020, with a total of 17,014 that targeted children used the activate engagement
patients (range 10e8058) and 8842 caregivers (range strategy, such as parental presence during painful in-
10e3413) (Table 1). Most studies reported on the terventions41 and parent-delivered acupressure mas-
number of caregivers (60 of 61; 99.4%), except for sage.75 Activate interventions were also common in
one study that reported on 8058 patients but did not adults (n ¼ 3 of 6; 50.0%),43,59,67 with most (n ¼ 2)
specify the number of caregivers.43 supporting mothers during labor (e.g., aroma-
therapy,43 verbal praise/physical touch67).
The next most common caregiver engagement strat-
Participant Characteristics egy was the multicomponent inform-activate-collaborate
Most studies reported on premature neonates (n ¼ 27 of (n ¼ 6 of 61; 9.8%).42,52,53,61,83,90 An example of an
61; 44.3%)37e40,45,47,49,50,52e54,56,63e66,70,72e74,76e80,91,92 or intervention that used the inform-activate-collaborate
full-term neonates (n ¼ 19 of 61; engagement strategy was the Comforting Your Infant in
31.1%),46,48,51,55,57,58,60,68,69,71,81,82,84e87,89,95,96 whose gesta- Intensive Care booklet on pain and comforting infants
tional age ranged from 28 to 40 weeks (Table 1). The re- in the neonatal ICU, which educated parents about
maining studies (n ¼ 15 of 61; 24.6%) reported on pain (inform), instructed them on pain management
patients with a mean age between 9.1 months and 73.3 years techniques (activate), and included nurse visits to sup-
(inclusive). Most studies reported on parents as the care- port parents (collaborate)52 (Appendix IV). Inform-acti-
giver (n ¼ 53 of 61; vate-collaborate interventions were also common in
86.9%)37e41,45e58,60e66,68e87,89e92,95e97 with most report- children (n ¼ 3 of 7; 42.9%),61,83,90 which educated
ing on mothers only (n ¼ 36 of 53; 67.9%). Forty-four (inform) and trained (activate) parents about pain
studies (n ¼ 44 of 61; 72.1%) reported caregiver sex. The management postsurgery and included collaboration
proportion of female caregivers in these studies ranged be- (collaborate) with the health care team or parent men-
tween 50% and 100%, with 86.4% (n ¼ 38 of 44) of studies tors. The remaining interventions used inform-activate
reporting only female caregivers. (n ¼ 5 of 61; 8.2%),62,88,93,96,97 activate-collaborate
(n ¼ 3 of 61; 4.9%),73,76,94 and inform (n ¼ 1 of 61;
Interventions 1.6%)44 engagement strategies across all age groups.
Studies reported a total of 21 unique caregiver-
facilitated pain management interventions, with most Outcomes
targeting neonates (Appendix IV). Studies compared Studies reported patient (n ¼ 56 of 61; 91.8%), care-
the pain management intervention to standard of giver (n ¼ 16 of 61; 26.2%), provider (n ¼ 3 of 61;
care or other pain management interventions 4.9%), and health system (n ¼ 4 of 61; 6.6%) out-
(Appendix IV). Most of the studies (n ¼ 28 of 61; comes (Table 3). Patient pain (n ¼ 54 of 56; 96.4%)
45.9%) had caregiver-facilitated pain management in- was the most common patient outcome reported, of
terventions delivered during routine blood sampling which most studies (n ¼ 42 of 54; 77.8%) used pain
(e.g., heel stick, heel lance). The next most common scales to measure pain, such as the Premature Infant
pain procedure targeted was vaccination or injections Pain Profile scale (n ¼ 19 of 42; 45.2%), the Neonatal
(n ¼ 12 of 61; 19.7%). Infant Pain Scale (n ¼ 10 of 42; 23.8%), and the
Most caregiver-facilitated pain management Neonatal Facial Coding System (n ¼ 4 of 42; 9.5%)
interventions used the activate caregiver engagement (Appendix V). Several studies (n ¼ 8 of 54; 14.8%) re-
strategy (n ¼ 46 of 61; 75.4%) (Table 2).37e41, ported physiological pain parameters, such as crying
43,45e51,54e60,63e72,74,75,77e82,84e87,89,91,92,95
The most (n ¼ 8 of 54; 14.8%), change in heart rate (n ¼ 6 of
common intervention that used the activate engage- 54; 11.1%), and change in oxygen saturation levels
ment strategy was kangaroo care (KC) (n ¼ 35 of 46; (n ¼ 2 of 54; 3.7%) instead of pain scales. Common
76.1%),37,45,47e51,54e58,63e66,68e72,74,76e82,85,86,89,91,92,95 caregiver outcomes (n ¼ 16) were knowledge about
wherein a parent provides skin-to-skin contact to an in- pain management (n ¼ 5 of 16; 31.2%), anxiety
fant by placing the diaper-clad infant on the parent’s (n ¼ 4 of 16; 25.0%), satisfaction with the patient’s
bare chest. Mothers were frequently the providers of pain management (n ¼ 4 of 16; 25.0%), depression
KC (n ¼ 31 of 35; 88.6%), referred to as (n ¼ 3 of 16; 18.8%), and stress (n ¼ 3 of 16;
kangaroo mother care,37,45,47e51,54,56,57,63e65,68e71,74, 18.8%) (Table 3). Provider outcomes (n ¼ 3) included
76,78e82,85,86,89,91,92,95
whereas few studies (n ¼ 4 of satisfaction (n ¼ 2 of 3; 66.7%), anxiety (n ¼ 1 of 3;
35; 11.4%) had either parent deliver KC.55,66,72,77 33.3%), and rate of desired/nondesired behaviors
Other common activate interventions included for effective pain management (n ¼ 1 of 3; 33.3%).
reserved.
1038
Table 1
Study Characteristics of Included Studies
Total Number Patient Male Caregiver Female Total Number
Patient Populationa Author (Yr) Location Study Design Setting of Patients Mean Ageb Patients (%) Populationc Caregivers (%) of Caregiversd
Premature Akcan et al. (2009)37 Asia Comparative and randomized controlled Single center 50 31.6 weeks 54.0 Parents (100%) 100 50
neonates study
Premature Axelin et al. (2006)38 Europe Randomized and crossover trial Single center 20 NR 40.0 Parents (100%) NR 20
neonates
Preterm Axelin et al. (2009)39 Europe Prospective randomized controlled crossover Single center 20 28.0 weeks 60.0 Parents (100%) NR 20
neonates design
Premature Axelin et al. (2010)40 Europe Prospective randomized placebo-controlled Single center 18 28.1 weeks 61.1 Parents (100%) NR 18
neonates crossover trial
Premature Campbell-Yeo et al. (2019)45 North America Single-blind RCT Single center 242 32.0 weeks 56.2 Parents (100%) 100 242
neonates
Premature Castral et al. (2008)47 South America Randomized design Single center 59 251.2 days 50.8 Parents (100%) 100 59
neonates (postmenstrual
age)
Preterm Chidambaram et al. (2014)49 Asia Crossover trial Single center 100 32.4 weeks 45.0 Parents (100%) 100 100
neonates
Premature Dezhdar et al. (2016)50 Asia Parallel-group controlled trial Single center 82 33.4 weeks 57.3 Parents (100%) 100 82
neonates
Premature Franck et al. (2011)52 Europe RCT Multicenter 169 30.5 weeks 46.2 Parents (100%) 96.4 169
neonates
Premature Franck et al. (2012)53 Europe RCT Multicenter 169 30.5 weeks 46.2 Parents (100%) 96.4 169
neonates
Healthy Freire et al. (2008)54 South America Randomized design Single center 95 NR NR Parents (100%) 100 95
preterm
neonates
56
Premature Gao et al. (2015) Asia RCT Single center 75 NR 49.3 Parents (100%) 100 75
neonates
Premature Johnston et al. (2003)63 North America Crossover design Multicenter 74 33.7 weeks 55.4 Parents (100%) 100 74
neonates
Premature Johnston et al. (2008)64 North America Single-blind crossover design Multicenter 61 30.5 weeks NR Parents (100%) 100 61
neonates
Yasmeen et al.
Premature Johnston et al. (2009)65 North America Single-blind crossover design Multicenter 90 33.4 weeks NR Parents (100%) 100 90
reserved.
neonates
Premature Johnston et al. (2011)66 North America Randomized crossover design Multicenter 62 NR NR Parents (100%) 50 124
neonates
Premature Kostandy et al. (2008)70 North America Prospective crossover design Single center 10 NR 50.0 Parents (100%) 100 10
neonates
Premature Kristoffersen et al. (2019)72 Europe Randomized crossover study Single center 35 NR 60.0 Parents (100%) NR 35
neonates
Critically ill Livingston et al. (2009)73 North America RCT Single center 12 35.5 weeks 41.7 Parents (91.7%) 100 12
premature Other family
neonates caregivers
(8.3%)
Premature Ludington-Hoe et al. (2005)74 North America Randomized and crossover trial Single center 23 31.4 weeks 56.5 Parents (100%) 100 23
neonates
Premature Miles et al. (2006)76 Europe Pragmatic and controlled trial Multicenter 78 28.0 weeks 61.5 Parents (100%) 100 78
neonates
Premature Mitchell et al. (2013)77 North America RCT Single center 38 28.8 weeks 50.0 Parents (100%) NR 38
neonates
Premature Mosayebi et al. (2014)78 Asia Single-blind crossover randomized clinical Multicenter 64 33.0 weeks 57.8 Parents (100%) 100 64
neonates trial
VLBW premature Nanavati et al. (2013)79 Asia Randomized study Single center 50 32.5 weeks NR Parents (100%) 100 50
neonates
Low birth weight Nimbalkar et al. (2013)80 Asia Randomized controlled double masked Single center 50 34.0 weeks 40.0 Parents (100%) 100 50
(<2500 g) crossover trial
premature
neonates
Premature Shukla et al. (2018)91 Asia RCT Single center 200 34.0 weeks 48.0 Parents (100%) 100 200
Vol. 60 No. 5 November 2020

neonates
Premature neonates Shukla et al. (2018)92 Asia RCT Single center 100 32.8 weeks 52.0 Parents (100%) 100 50
Full-term neonates Carbajal et al. (2003)46 Europe RCT Single center 179 39.8 weeks 52.0 Parents (100%) 100 179
Full-term neonates Chermont et al. (2009)48 South America Prospective, randomized, partially blinded, Single center 640 39.0 weeks 50.0 Parents (100%) 100 640
and clinical trial
Full-term neonates Fallah et al. (2017)51 Asia Randomized single-blind clinical, and parallel Single center 120 NR 58.3 Parents (100%) 100 120
group trial
Full-term neonates Gabriel et al. (2008)55 Europe Controlled clinical trial Single center 54 35.3 weeks NR Parents (100%) NR 54
Full-term neonates Gray et al. (2000)57 North America Prospective RCT Single center 30 NR 36.7 Parents (100%) 100 30
Full-term neonates Gray et al. (2002)58 North America Prospective RCT Single center 30 39.9 weeks 43.3 Parents (100%) 100 30
Full-term neonates Hashemi et al. (2016)60 Asia Randomized double-blind study Single center 131 38.7 weeks 55.7 Parents (100%) 100 131
Full-term neonates Kashaninia et al. (2008)68 Asia Randomized study Single center 100 39.2 weeks 44.0 Parents (100%) 100 100
Full-term neonates Khodam et al. (2002)69 Asia Randomized study Single center 30 NR NR Parents (100%) 100 30
Full-term infants Kostandy et al. (2013)70 North America Two-group RCT Single center 36 26.4 hours 50.0 Parents (100%) 100 36
Full-term neonates Noghabi et al. (2011)81 Asia Randomized study Single center 100 39.2 weeks 44.0 Parents (100%) 100 100
Full-term neonates Okan et al. (2010)82 Asia Prospective, randomized, and controlled Single center 107 39.5 weeks 47.7 Parents (100%) 100 107
study
Full-term neonates Phillips et al. (2005)84 North America Prospective, randomized, and controlled trial Single center 96 36.8 hours 39.6 Parents (100%) 100 96

Full-term neonates Saeidi et al. (2007)85 Asia Randomized case-control clinical trial Single center 60 NR NR Parents (100%) 100 60
Full-term neonates Saeidi et al. (2011)86 Asia Semiexperimental double blind, double Single center 60 NR 46.7 Parents (100%) 100 60
group, and clinical trial
Full-term neonates Savaşer (2000)87 Asia Experimental Single center 70 39.8 weeks 44.3 Parents (100%) 100 70
Full-term neonates Seo et al. (2016)89 Asia Prospective study Single center 56 38.4 weeks 51.8 Parents (100%) 100 56
Full-term neonates Soltani et al. (2018)95 Asia Double-blinded and randomized clinical trial Single center 161 NR 57.8 Parents (100%) 100 161
Full-term neonates Taddio et al. (2018)96 North America Longitudinal, three-group parallel, RCT Single center 3413 9.1 months NR Parents (100%) 100 3413
Children in the PED Bauchner et al. (1996)41 North America RCT Single center 435 NR 41.8 Parents (95.6%) NR 428
Other (4.4%)
Children who Huth et al. (2003)61 North America Randomized and repeated measures Single center 51 9.0 yrs 49.1 Parents (100%) NR 51
had cardiac
surgery
Children Jenkins et al. (2019)62 North America Prepost study Single center 112 6.2 yrs 58.0 Parents (100%) NR 112
undergoing
surgery
Children Mehling et al. (2012)75 North America Randomized and nonblinded pilot study Single center 23 12.1 yrs 56.5 Parents (100%) NR 23
with HCT
Children with Pattangtanang et al. (2018)83 Asia Two-group prepost study Single center 40 13.5 months 52.5 Mothers (75.0%) 92.5 40
cleft lip and Grandmothers
palate undergoing (17.5%)
palatoplasty Fathers (7.5%)
Children with Sharek et al. (2006)90 North America Cohort study Single center 27 4.9 yrs 48.1 Parents (100%) NR 27
postoperative
liver transplant
Children Zhu et al. (2018)97 Asia Prepost test RCT Single center 152 9.6 yrs 64.5 Parents (100%) 86.8 152
undergoing
inpatient elective
Caregiver-Mediated Pain Management in Hospitalized Patients

surgery
Mothers Burns et al. (2000)43 Europe Evaluative study Single center 8058 NR 0 Midwives (100%) NR NR
who gave birth
Mothers giving birth Khresheh (2010)67 Asia Nonrandomized comparison study Single center 226 25.7 yrs 0 Family 100 107
caregivers (100%)
Adults with Hudgens (1979)59 North America Prepost study Multicenter 24 46.0 yrs 25.0 Significant NR 24
chronic pain others (100%)
Adults Rahmani et al. (2020)93 Asia Non-RCT Single center 46 37.9 yrs 82.6 Significant NR 46
undergoing others (% NR)
orthopedic Siblings (% NR)
surgery Adult
children (% NR)
reserved.
Parents (% NR)
Adults with cancer Samancioglu & Bakir (2019)94 Asia Two-group prepost study Single center 60 47.6 yrs 53.3 Family 75.0 60
caregivers (100%)
Adults with Stephenson et al. (2007)88 North America Prepost study Multicenter 86 58.2 yrs 48.8 Informal NR 86
metastatic cancer caregivers (100%)
Older adults Berthelsen & Kristensson (2017)42 Europe Two-group quasi-experimental, pretest, Single center 29 73.3 yrs 41.4 Significant NR 29
with total hip repeated post-test others (100%)
replacement
surgery because
of arthritis
Older adult Cagle et al. (2015)44 North America Cluster, randomized, and controlled trial Multicenter 126 72.3 yrs 49.2 Significant 77.8 126
palliative patients others (40.5%)
(mostly cancer) Adult
children (34.1%)
Other family
caregivers (16.7%)
Parents (4.8%)
Other (4.0%)
NR ¼ not reported in the study; RCT ¼ randomized controlled trial; VLBW ¼ very low birth weight; PED ¼ pediatric emergency department; HCT ¼ hematopoietic cell transplant.
a
Studies are sorted by patient population.
b
Age in gestational weeks, hours, days, months, or years (yrs).
c
Family caregivers: studies identified family members were involved but did not specify the relationship; informal caregivers: studies referred to caregivers as being a close carer who regularly looks after the patient.
d
Caregivers were involved in all interventions, but the number of caregivers was not reported in every study.
1039
1040
Table 2
Type and Effectiveness of Interventions Based on Type of Caregiver Engagement
Type of Caregiver Engagement
(n ¼ Number of Studies) Patient Outcomes (All)a Patient Outcomes (Pain) Caregiver Outcomes Provider Outcomes Health System Outcomes
Inform (n ¼ 1) 44
1b,44 1b,44 1b,44 d d
Activate (n ¼ 46)37e41,43,45e51,54e 35 b,37,39,40,46e51,54,56e58,60,63,64,66e
32 b,37,39,46e51,54,56e58,60,63,66e
1b,41
60,63e72,74,75,77e82,84e87,89,91,92,95 71,74,78-82,84e87,89,91,95 68,70,71,74,78e82,84e87,89,91,95
3c,38,d,59,d,75 1c,41
3c,37,59,d,75
10c,41,43,d,45,55,59,d,65,72,75,77,92 11c,41,43,d,45,55,64,65,69,72,75,77,92
Inform-activate (n ¼ 5)62,88,93,96,97 4b,62,88,93,96 4b,62,88,93,96 3b,62,96,97 1b,62 d
1c,97 1c,97
Activate-collaborate (n ¼ 3) 73,76,94
1b,94 1b,94 1 b,94
1c,76 1c,76 2c,73,d,76 1c,73,d 1c,73

Inform-activate-collaborate 1b,90 1b,90 1b,83 d d
(n ¼ 6)42,52,53,61,83,90 2c,42,61 2c,42,61 4c,42,52,53,61
Numbers refer to the number of studies reporting each outcome.
a
Includes studies that reported patient pain.
b
Statistically significant positive effect of intervention.
c
No statistically significant or inconsistent effect of intervention.
d
Outcomes were not analyzed to test for statistical significance.
Yasmeen et al.
reserved.
Table 3
Type and Effectiveness of Interventions Based on Patient Population
Caregiver Provider Health System
Study Population (n ¼ Number of Studies) Patient Outcomes (All)a Patient Outcomes (Pain) Outcomes Outcomes Outcomes
All 42b,37,39,40,44,46e51,54,56e58,60,62e64,66e71, 39b,37,39,44,46e51,54,56e58,60,62,63,66e68, 7b,41,44,62,83,94,96,97 1b,62
74,78e82,84e91,93e99 70,71,74,78e82,84e91,93e96
9c,38,d,42,52,53,59,d,61, 2c,41,73,d 4c,37,59,d,73,d,75
73,d,75,76
14c,41e43,d,45,55,59,d,61,65,72,75e77,92,97 15c,4143,d,45,55,61,64,65,72,7577,92,97
Patient population (age)
Premature neonates (n ¼ 27)37e40,45,47,49, 17b,37,39,40,47,49,50,54,56,63,64,66,70,74,78e80,91 15b,37,39,47,49,50,54,56,63,66,70,74,78e80,91
50,52e54,56,
6c,45,65,72,76,77,92 7c,45,64,65,72,76,77,92 5c,38,d,52,53,73,d,76 1c,73,d 2c,37,73,d
63e66,70,72e74,76e80,91,92
Full-term neonates 18b,46,48,51,57,58,60,68,71,81,82,84e87,89,95,96 17b,46,48,51,57,58,60,68,71,81,82,84e87,89,95,96 1b,96 d

(n ¼ 19)46,48,51,55,57,58,60,68,69,71,81,82,84e87,89,95,96 1c,55 2c,55,69
Children (n ¼ 7)41,61,62,75,83,90,97

2a,62,90 2b,62,90 4b,41,62,83,97
1b,62
4c,41,61,75,97 4c,41,61,75,97 2c,61,75 1c,41 1c,75
Adults (n ¼ 6)43,59,67,88,93,94 4b,67,88,93,94 4b,67,88,93,94 1b,94 d
2c,43,d,59,d 1c,43,d 1c,59,d 1c,59,d
Older adults (n ¼ 2)42,44 1b,44 1b,44 1b,44 d d
1c,42 1c,42 1c,42
a
b
c
No statistically significant effect of intervention.
d
Health system outcomes (n ¼ 4) included length of Acceptability and Feasibility

hospital stay (n ¼ 3 of 4; 75.0%) and use of the health Included caregiver-facilitated pain management in-
care system (e.g., interaction with hospital staff and terventions appeared to be acceptable and feasible
community physicians) at patient discharge (n ¼ 1 with no caregivers expressing any complaints. When
of 4; 25.0%) reported (n ¼ 6 of 61; 9.8%), caregivers were
Most caregiver-facilitated pain management inter- satisfied38,41,42,61,73,97 with the interventions and re-
ventions improved patient outcomes (n ¼ 42 of 56; sponded positively to them. For example, parents
75.0%). Most interventions that improved patient out- who received a booklet on pain and comforting neo-
comes used an inform-activate (n ¼ 4 of 5; 80.0%) or nates in the neonatal ICU reported that they were
activate engagement strategy (n ¼ 35 of 45; 77.8%) more satisfied with information they received on
(Table 2). Other interventions that used inform pain than parents who did not receive the booklet
(n ¼ 1 of 1; 100%), inform-activate (n ¼ 4 of 5; (P < 0.001).52
80.0%), activate (n ¼ 32 of 43; 74.4%), and activate-
collaborate (n ¼ 1 of 2; 50.0%) engagement strategies ROB and Strength of Evidence
improved patient pain (Table 2). Only one inform-acti- Most studies were of low (n ¼ 36 of 61; 59.0%) or
vate-collaborate (n ¼ 1 of 3; 33.3%) intervention high (n ¼ 14 of 61; 23.0%) ROB (Appendix VI).
improved patient pain. Inform-activate interventions The domain for blinding of participants and
(n ¼ 3 of 3) reported improved caregiver outcomes, personnel was rated as high ROB for most studies
including increased rate of desired pain management because the nature of caregiver-facilitated pain man-
behaviors62 and improved knowledge about pain in- agement interventions does not allow patients and
terventions96,97 (Table 2). Overall, most caregiver caregivers to be blinded. The ROB for blinding of
engagement strategies (n ¼ 9 of 16; 56.3%) did not outcome assessors was mostly low (n ¼ 25 of 61;
improve caregiver outcomes. Only one intervention 41.0%) or high (n ¼ 23 of 61; 37.7%). Review results
(inform-activate) improved provider outcome (n ¼ 1 were similar when restricted to studies with an overall
of 3; 33.3%) in the form of increased rate of desired low ROB, with caregiver-facilitated pain management
behaviors and reduced rate of nondesired pain man- interventions improving patient pain but not affecting
agement behaviors.62 No engagement strategy caregiver or health system outcomes (provider out-
improved health system outcomes reported (Table 3). comes were not reported by these studies)
(Appendix VII). The level of evidence for RCTs was
downgraded because of overall unclear ROB and
Patient Population Subgroups imprecision because of small sample sizes (Appendix
The most common patient age group in the studies VIII).
were premature neonates (n ¼ 27 of 61; 44.3%), fol-
lowed by full-term neonates (n ¼ 19 of 61; 31.1%),
children (n ¼ 7 of 61; 11.5%), adults (n ¼ 6 of 61; Discussion
9.8%), and older adults (n ¼ 2 of 61; 3.3%)
The current systematic review identified 61 studies
(Table 3). The interventions improved patient pain
including 17,014 patients that reported caregiver-
in premature neonates (n ¼ 15 of 22; 68.2% studies
facilitated pain management interventions in hospital-
that reported patient pain in this age group), full-
ized patients, most of which included neonates. Most
term neonates (n ¼ 17 of 19; 89.5% studies that re-
studies reported on caregiver-facilitated pain manage-
ported patient pain in this age group), and adults
ment interventions that used the activate engagement
(n ¼ 4 of 5; 80.0% studies that reported patient pain
strategy (i.e., activate, inform-activate, activate-collaborate,
in this age group). Caregiver outcomes were improved
inform-activate-collaborate). Most caregiver-facilitated
in caregivers of children (n ¼ 4 of 6; 66.7%). There
pain management interventions that used an activate
were no overall differences in provider and health sys-
engagement strategy (activate, inform-activate, and
tem outcomes based on patient age.
inform-activate-collaborate) improved patient pain in ne-
onates (preterm and full-term). The few studies of
adults (18e64 years) also showed that single and
Adverse Events multicomponent activate (inform-activate and activate-
Studies infrequently reported adverse events collaborate) interventions improved pain. Results were
(n ¼ 10 of 61). When adverse events were reported, inconclusive for caregiver-facilitated interventions
studies only stated that no serious adverse events had that targeted children and older adults (65 years and
occurred. The reported caregiver-facilitated pain man- older) because of the small number of studies. One
agement interventions were not associated with re- study that reported on caregiver-facilitated pain man-
ported harms. agement intervention using the inform strategy
reserved.
improved patient (pain) and caregiver (pain knowl- the most effective intervention. An advantage of acti-
edge) outcomes. Inform-activate interventions reported vate interventions, such as KC or supporting new
improved caregiver outcomes. One inform-activate mothers during labor, is that they are simple interven-
intervention improved provider outcome, and no in- tions that caregivers can learn and apply easily. Trans-
terventions were reported to improve health system ferring pain management interventions from nurses
outcomes, although only a few studies reported on to caregivers can alleviate the burden on nurses and
these. potentially improve patient pain. In contrast, an acti-
The observation that caregiver-facilitated pain man- vate intervention such as delivering acupressure mas-
agement interventions that use an activate engage- sage may take more time to learn. However, after the
ment strategy improved pain in neonates and adults initial training stage, alleviation of patient pain can
(18e64 years) is similar to a recent systematic review be shared between the health care team and care-
that reported complex caregiver-facilitated interven- givers. Further investigation is needed to test the effec-
tions that used the activate strategy (inform-activate tiveness of the other (i.e., inform, collaborate)
and inform-activate-collaborate) were associated with engagement strategies, although other studies have
improved patient and caregiver outcomes.33 Although theoretically suggested the potential of inform inter-
most caregiver-facilitated interventions reported in ventions in managing pain.98,103,104
the literature used the inform strategy, most reported Our systematic review of the literature identified few
caregiver-facilitated pain interventions included in studies that reported on caregiver-facilitated pain
the present study used an activate strategy. This is management interventions for children, adults, and
because the existing literature has been focused on older adults. There are studies that report on pain
procedural pain and caregiver-facilitated pain inter- management interventions in these groups in a hospi-
ventions among neonates. Most literature on tal setting, but interventions were delivered by pro-
caregiver-facilitated pain interventions in children viders or researchers, not caregivers, and were thus
has been focused on caregiver-facilitated pain inter- not eligible for inclusion in this systematic review.
ventions that address chronic or postoperative pain Pain management interventions administered by pro-
in community settings,98,99 interventions delivered by viders or researchers included distraction methods
the study or health care team or self-administered by for postoperative pain (e.g., storytelling)105 and music
children, or interventions that targeted caregivers therapy during a procedure106 in children, and thera-
(e.g., pain management attitude, anxiety coping pies such as relaxation107,108 and massage109e111 in
style).100 Although there is limited investigation of adults. These interventions were shown to reduce
caregiver-facilitated pain management interventions pain and symptoms of anxiety in hospitalized children
in older adults, suggestions have been made on how and adults, but further research is needed to evaluate
caregivers can be involved (activate): distraction, remi- if these interventions are effective when facilitated by
niscence therapy, relaxation techniques, physical in- caregivers.
terventions (e.g., massage), and environmental This review has many strengths, including use of
modifications (e.g., aromatherapy).101 The potential rigorous systematic review methodology and a prereg-
for caregiver-facilitated inform interventions in hospi- istered protocol. The search strategy was developed
talized children and older adults required further with experts in caregiver-facilitated interventions (H.
study. T. S. and K. M. F.) and included five large online data-
The included studies in this systematic review sug- bases, with no restrictions on language, followed by
gest that caregiver-facilitated pain management inter- full-text handsearching of reference lists. We focused
ventions did not impact provider or health system on caregiver-facilitated pain management in hospital-
outcomes. Health care staff did not get more anxious ized patients, excluding community-based interven-
when parents were present during painful proced- tions (which excluded many studies on caregiver-
ures41 and were satisfied with massage as a pain man- facilitated pain management in patients with chronic
agement intervention.73 Results suggest that these pain). Our systematic review also has limitations.
interventions did not create organizational barriers Although we used rigorous systematic review method-
despite not being part of standard of care, which is a ology, it is possible that studies may have been missed.
common perceived barrier of nonpharmacological Another limitation is the use of the novel natural lan-
pain management strategies.102 Because of the small guage processing tool, DistillerAI, which has yet to be
number of studies that reported on provider and validated. However, all titles and abstracts were
health system outcomes, further investigation is screened by at least one reviewer, and two reviewers
required. screened all full-text articles (not DistillerAI). All
This systematic review suggests that engagement of studies had a high ROB in the domain for blinding
caregivers in pain management using the activate strat- of participants and personnel, which is a natural
egy reduces pain in hospitalized neonates, with KC as consequence of caregiver-facilitated pain
reserved.
management interventions. However, outcome asses- of the report; or decision to submit the article for
sors were mostly blinded, which is important when as- publication.
sessing effectiveness of interventions. Ethical approval and consent to participate: Not
The included studies were rated as of low quality applicable.
because of study design (i.e., not RCT), the absence Consent for publication: Not applicable.
of effect size calculations, and small sample sizes. Availability of data and materials: All data generated
Although some studies included sample size calcula- or analyzed during this study are included in this pub-
tions, many did not report the effect size of the inter- lished article (and its supplementary information
vention or reported inadequate information for us to files).
determine effect sizes. Future studies could enhance The authors declare no conflicts of interest.
the quality of evidence by using an RCT design,
increasing sample sizes, and reporting CIs and effect
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Vol. 60 No. 5 November 2020 Caregiver-Mediated Pain Management in Hospitalized Patients 1046.e1
Appendix I.
Search Strategy
MEDLINE
1. exp caregivers/
2. caregiv*.mp.
3. (care adj2 giver*).mp.
4. carer*.mp.
5. exp family/
6. famil*.mp.
7. exp parents/
8. parent*.mp.
9. exp spouses/
10. spous*.mp.
11. adult child*.mp.
12. exp Adult Children/
13. (father* or mother*).mp.
14. friend*.mp.
15. (husband* or wife or wives).mp.
16. partner*.mp.
17. ("next of kin" or relative*).mp.
18. support person.mp.
19. (relative* adj3 care).mp.
20. "loved one*".mp.
21. "significant other*".mp.
22. "informal carer*".mp.
23. or/1-22
24. extended famil*.mp.
25. exp Nuclear family/
26. nuclear famil*.mp.
27. exp volunteers/
28. (voluntary or volunteer*).mp.
29. (family adj2 centered adj2 care).mp.
30. (family adj2 centered adj2 care).mp.
31. exp family therapy/
32. family therapy.mp.
33. or/24-32
34. 23 or 33
35. ((voluntary or volunteer*) adj3 care).mp.
36. (patient adj3 care).mp.
37. (partner* adj3 care).mp.
38. (family adj3 centered).mp.
39. (family adj3 centered).mp.
40. (caregiver adj3 mediated).mp.
41. care*.mp.
42. (sharing or share*).mp.
43. or/35-42
44. intervention*.mp.
45. exp randomized controlled trials as topic/
46. exp Randomized Controlled Trial/
47. exp Double-Blind Method/
reserved.
1046.e2 Yasmeen et al. Vol. 60 No. 5 November 2020
48. ("double blind" or double-blind).mp.

49. exp Single-Blind Method/
50. ("single blind" or single-blind).mp.
51. exp Random Allocation/
52. random allocation.mp.
53. exp Control Groups/
54. control group*.mp.
55. (randomi?ed control* adj2 trial).mp.
56. randomi?ed.mp.
57. RCT*.mp.
58. (before adj1 after).mp.
59. (pre adj1 post).mp.
60. or/44-59
61. exp PAIN/
62. pain*.mp.
63. exp Pain Management/
64. (pain adj3 manag*).mp.
65. exp PAIN MEASUREMENT/
66. (pain adj3 measur*).mp.
67. (pain adj3 parameter*).mp.
68. (pain adj3 evaluat*).mp.
69. (pain adj3 assess*).mp.
70. (pain adj3 tool*).mp.
71. (experience adj3 pain).mp.
72. exp ANALGESIA/
73. analges*.mp.
74. or/61-73
75. exp Critical Care/
76. critical care.mp.
77. critical* ill*.mp.
78. exp Intensive Care Units/
79. intensive care.mp.
80. ICU.mp.
81. exp HOSPITALS/
82. hospital*.mp.
83. clinical care.mp.
84. or/75-83
85. 34 and 43 and 60 and 74 and 84
Appendix II.
Study Selection Using DistillerSR
We uploaded all search results from our original search (September 6, 2018) from the database into Distill-
erSR. After we removed duplicates, two reviewers (C. Z. and I. Y.) independently screened and agreed on
19% (n ¼ 2314) of titles and abstracts according to the following inclusion criteria: 1) original research (i.e.,
not a review); 2) interventional study design; 3) intervention mediated by the caregiver and directed to a patient;
4) intervention related to pain management or measurement; 5) comparator groups; and 6) patient, caregiver,
provider, or health system outcomes. We screened 19% of citations because this set had the number of included
($10) and excluded ($40) references recommended by DistillerSR guidelines.31 Next, this set of included and
excluded citations was used to train the DistillerAI software toolkit, a toolkit used in other systematic reviews.32,33
reserved.
The software uses traditional machine learning methods, such as a Naive Bayes classifier and a Support Vector
Machine classifier, to classify citations as included or excluded. The software randomly split these citations
into a training set that trained DistillerAI (n ¼ 1852 of 2314; 80%) and a test set that compared inclusion and
exclusion decisions made by DistillerAI with human-screened decisions (n ¼ 462 of 2314; 20%). DistillerAI
scored these citations on a scale of 0e1 in terms of their likelihood for inclusion (1 is strong include and 0 is
strong exclude). Each time we trained DistillerAI, we reviewed the human-screened decisions, artificial intelli-
gence (AI) decisions, and scores for these citations. Then, we tested the accuracy of AI as a reviewer by selecting
an inclusion threshold (between 0 and 1) and having AI screen a set of unreviewed citations. After reviewing the
scores given to citations and whether they were correctly being included according to our inclusion criteria, we
selected a threshold score of 0.60 for inclusion to be used by AI when screening the remaining citations. As the
following step, the remaining titles and abstracts (n ¼ 9841) were screened by at least one reviewer (C. Z. or I. Y.)
and in duplicate by DistillerAI as a second screener for 81% (n ¼ 9806 of 12,155) of the citations. DistillerAI
agreed on 98.5% (n ¼ 4823) of citations that were screened in duplicate with I. Y. (n ¼ 4898) and 99.1%
(n ¼ 4866) of citations that were screened in duplicate with C. Z. (n ¼ 4908). There were no limitations on lan-
guage (abstracts in English were commonly available) or time of publication. Next, studies selected by a reviewer
or DistillerAI were included in full-text review. DistillerAI was only involved in the title and abstract screening
stage, whereas full-text articles were independently screened by the same two reviewers (C. Z. and I. Y.). We iden-
tified additional studies by searching the bibliography of included studies. The search was updated on April 14,
2020, and 1751 titles and abstracts were screened independently and in duplicate by three reviewers (I. Y., C. Z.,
and K. D. K.).
reserved.
1046.e4 Yasmeen et al. Vol. 60 No. 5 November 2020
Appendix III
Classification of Caregiver Engagement in Caregiver-Mediated Interventions
Engagement Engagement Support
Inform Condition and treatment education

Interventions that educate caregivers on disease condition Information provision on patient’s condition, prognosis,
and/or treatment and management and how to manage patient condition
Lifestyle advice
Information provision on how caregivers can help with
lifestyle behaviors such as diet and adapting the home
environment
Activities of daily living
Information provision on how caregivers can support
patients in activities of daily living, including dressing,
eating, walking, and transportation
Activate Physiological monitoring
Interventions that prompt caregivers to play an active role Caregivers are prompted to monitor and record patients’
in patient care physiological parameters such as blood sugar
Action plans for condition
Caregivers receive and are trained to deliver treatment
plans specific to the patient’s condition, such as
following an exercise plan created by the physical
therapist or developing a routine for play with infants
Practical management activities
Caregivers actively assist patients with managing their
condition, such as helping patient with limb positioning
Lifestyle monitoring
Caregivers monitor and record lifestyle behaviors, like
daily weight and regular exercise
Provision of equipment
Caregivers are provided equipment to help manage
patient’s condition, such as a Fitbig Zip to motivate
patients to exercise more regularly
Psychological strategies
Caregivers are trained on goal setting and problem solving
Collaborate Available resources
Interventions encourage caregivers to collaborate and Provision of contact details outside the study team that can
engage with providers or other caregivers and provides offer additional services and assistance, such as referrals
them resources for further support to health care professionals
Communication with providers
Caregivers are trained or mentored on how to
communicate with health care professionals
Safety netting
Provision of additional support and guidance from study
team members, including a 24-hour hotline, the
therapist being available postintervention, and
telephone consultations postintervention
Social support
Provision of support, mentoring, or socializing by the
study team or other organizations. Support can be from
health care organizations or other caregivers. This
includes group sessions with other participants or the
opportunity for patients to discuss their psychosocial
problems
Adapted from Fiest et al. (2018).33
reserved.
Appendix IV
Description of Interventions and Reported Outcomes
Author (Yr) Intervention Caregiver Engagement and Support Outcomes
Akcan et al. (2009)37 Control: Infants received standard care. Vein Activate Patient
or heel blood sample was taken while they Practical management activities Pain score was lower in the
were lying down quietly in the incubator intervention group throughout all
or crib time points during the blood
Intervention: Infants received KMC for a 45-
minute interrupted period every day for sampling (first, second, and third
five days. The infant only wore a diaper minutes) and right after blood
and cap, and the mother wore a gown with sampling (first and second minutes
the chest area open. The infant was placed after)
between the mother’s breasts, and the Health system
infant’s head was upright. A blanket No difference in length of hospital
covered the infant’s back to reduce heat stay between control, 16.1 (13.4)
loss. As part of routine care, a heel or vein
blood sample was taken from the infant on days, and intervention groups, 21.4
the fifth day of the intervention, after the (13.4) days
infant had already received 30 minutes of

KMC. The position was maintained for
10 minutes after blood sample was taken
Axelin et al. (2006)38 Control: Using crossover design, the order of Activate Caregiver (qualitative)
intervention was based on randomization. Practical management activities About 95% (19 of 20) parents
In the control group, the nurse was preferred active participation in
allowed to talk to the infant and pat the pain management during
infant during endotracheal/pharyngeal
suctioning. Procedures were videotaped to suctioning compared with passive
analyze pain in infants observation. About four of 20 felt
reserved.
Intervention: Using crossover design, the that the intervention helped them
order of intervention was based on to cope better with their own stress.
randomization. Infants in the intervention About six of 20 felt that infants
group received FTP during endotracheal were less in pain during facilitated
suctioning and afterward until the infant tucking
had relaxed. One parent per infant was
trained to deliver this intervention.
Procedures were videotaped to analyze
pain in infants
Axelin et al. (2009)39 Infants underwent four 25-minute nursing Activate Patient
care episodes, which were standardized. Practical management activities Only in the FTP group both PIPP and
The order of interventions for the first NIPS scores were lower compared
three nursing care periods was with control group during
randomized. Opioid was always given in
the last nursing care episode to prevent pharyngeal suctioning and heel
carryover effects. stick. The oral glucose group
Control: For the placebo group, infants reported lower PIPP pain scores
received 0.2 mL of sterile water on the tip compared with control group
of their tongue two minutes before and during both painful procedures,
immediately before the painful procedure but there was no difference in NIPS
(heel stick and pharyngeal suctioning) pain scores. There was no
Facilitated tucking: Parents were taught the difference in PIPP or NIPS pain
technique of FTP. They positioned and
held the infant in a side-lying position so scores during the two painful
the infant was flexed and in a fetal-type procedures between the opioid and
position before, during, and after painful control groups
procedures (heel stick and pharyngeal
suctioning) until the infant calmed down
Opioid: Opioid was always given in the last
1046.e5
nursing care episode to prevent carryover
(Continued)
Appendix IV
1046.e6
Continued
effects. In the opioid group, infants were

administered oxycodone hydrochloride
(0.05 mg/kg) 10 minutes before the
nursing care episode. Heel lance occurred
15 minutes later, and endotracheal
suctioning occurred 25 minutes later
Oral glucose: Infants received 0.2 mL of
glucose (24%) on the tip of their tongue
two minutes before and immediately
before the painful procedure (heel stick
and pharyngeal suctioning)
Axelin et al. (2010)40 The 13-hour study period was between 1:00 Activate Patient
PM and 2:10 AM. Starting at 2:00 PM, infants Practical management activities The opioid group had lower amount
had four standardized nursing care of REM sleep compared with
periods, each lasting 25 minutes, at three-
hour intervals. There was a resting period control group and the
of two hours and 35 minutes between nonpharmacological pain
caregiving periods. Nursing care included management groups. The opioid
measurement of blood pressure and group also had increased amount
temperature, heel stick, diaper change, of NREM sleep compared with the
sensor replacement, pharyngeal other groups
suctioning, positioning, and starting There was no difference in median
feeding through nasogastric tube sleep latency (time between end of
Yasmeen et al.
Control: Two minutes before and nursing care and first stage of
reserved.
immediately before heel stick and

pharyngeal suctioning, infants were given sleep) between all groups
sterile water (0.2 mL) on the tip of their
tongue through a syringe, which was a
form of placebo
Facilitated tucking: Parents were taught how
to perform facilitated tucking. They held
the infant in a side-lying, flexed, and fetal
position before heel stick and pharyngeal
suctioning and continued after the
procedure until the infant was calm
Opioid: 10 minutes before the last nursing
care period, infants were given oxycodone
hydrochloride (0.05 mg/kg)
intravenously. About 15 minutes later, heel
lance was conducted, and pharyngeal
suctioning occurred 25 minutes after
opioid dose
Oral glucose: Two minutes before and
immediately before heel stick and

pharyngeal suctioning, infants were given
24% glucose (0.2 mL) on the tip of their
tongue through a syringe
Bauchner et al. (1996)41 Control: No parental presence. Parents were Activate Patient
told the health care team did not like it Practical management activities No difference in pain rating by
when parents are present during parents or by clinicians between all
procedures (venipuncture, intravenous
cannulation, or uretheral catheterization) three groups. No difference in
Parent presence: Parental presence only. crying between all three groups
Parents were told that the health care Caregiver
team liked parents to be present during Parents in the intervention group
procedures (venipuncture, intravenous (mean score 40.7) and parental
cannulation, or uretheral catheterization) presence group (mean score 41.4)
Intervention: Parental presence and were less anxious than parents in
teaching of parents on how to calm the control group (mean score
patient down. Parents were told that the 45.2). No difference in levels of
health care team liked parents to be
present during procedures (venipuncture, satisfaction with care between all

intravenous cannulation, or uretheral three groups

catheterization) and that they will be Provider
taught techniques to calm the patient There was no difference in anxiety
down. Parents were asked to sit at the head scores between all three groups
of the bed and to talk, touch, and (intervention: 34.0; parental
maintain eye contact with the child presence: 33.6; control: 32.5).
Parental presence or parents being
involved in the intervention did
not make clinicians more anxious
Berthelsen & Kristensson (2017)42 Control: Usual care consisting of Inform Patient
information provision on daily goals on Condition and treatment education At three months, no difference in
pain management, mobilization, and Activate pain or depression between control
nutrition and discharge preparation Psychological strategies and intervention groups. Pain
Intervention: Case management where case
Collaborate decreased within groups

managers provided additional support
and guidance regarding rehabilitation, Communication with providers Caregiver
exercise, pain management, and nutrition. Safety netting At three months, no difference in
Case managers met with spouses starting difficulty in caring, satisfaction, or
from before patients were admitted until anxiety between groups
two-week postdischarge. Before patient
was admitted, spouse’s needs were
assessed, and an individual plan was
developed based on goal setting and
reserved.
actions together with the patient and

spouse. Spouses were encouraged to
attend meetings with providers (surgeons
and physiotherapists) based on needs that
were identified. Case managers had an
additional discharge meeting with the
spouse regarding problems to expect
postdischarge. A few days later, the case
manager called the spouse to follow-up on
the problems identified in the individual
plans and inform spouses how they can
support the patient with rehabilitation,
pain management, and nutrition. Finally,
the case manager met with the spouse to
discuss the same topics as the phone call
two-week postdischarge at the outpatient
clinic when the patient was getting sutures
removed
Burns et al. (2000)43 Control: No oils used during labor Activate Patient (qualitative)
Intervention: Aromatherapy was Practical management activities Aromatherapy was most commonly
administered by a group of midwives, with used during labor (60%). Some
the aromatherapist providing supervision.
The protocol was restricted to 10 oils women used it for pain relief
chosen by the aromatherapist. Most during labor (n ¼ 537). Select
common methods of administration were essential oils administered through
through a taper/drop on pillow, massage, aromatherapy were rated by
or foot bath. Other methods were drop in mothers to be helpful in relieving
bath, drop on brow/palm, and perineal pain during labor. Common
lavage. Most participants used
1046.e7
essential oils were lavender (64%)
aromatherapy during labor and frankincense (12%). Both
(Continued)
Appendix IV
1046.e8
Continued
lavender (54%) and frankincense

(64%) were rated to be helpful.
The other reason for using
aromatherapy during labor was to
relieve anxiety (n ¼ 4853), and
common essential oils were
lavender (52%), frankincense
(33%), and rose oil (5%). Order of
helpful rating was rose oil (71%),
lavender (50%), and frankincense
(44%), respectively
Cagle et al. (2015)44 Control: Usual care Inform Patient
Intervention: Families were screened by Condition and treatment education At two weeks, patients in the
hospice nurses on whether they tested intervention group were perceived
positive for any of the eight common to be in less pain by caregivers
concerns/barriers regarding pain that the
EMPOWER brochure outlines. If they (mean score 4.2 [SE 0.4] vs. 5.7
were screened to be positive, the [0.4]) in the past week. No
caregiver/patient received the brochure, difference in pain perception at
and the hospice nurse discussed the the moment the survey was
content, particularly the barrier in administered
question. All families received the Caregiver
Yasmeen et al.
brochure even if they did not test positive At two weeks, the intervention group
reserved.
for any of the concerns, but not everyone showed increased knowledge
received discussion from the trained
hospice nurse related to pain and pain
management (mean score 2.76 [SE
0.05] vs. 2.54 [SE 0.04]). This trend
was maintained at three months
At two weeks, caregivers in the
intervention group reported
decreased pain barriers. There was
no difference in caregivers’
perceived control over the patient’s
pain and other symptoms
Campbell-Yeo et al. (2019)45 Control: Infants were placed in a supine Activate Patient
position in an incubator or a cot. Two Practical management activities There were no statistically significant
minutes before heel lance, they were differences in percentage of infants
provided 24% oral sucrose solution to the reported as having mild, moderate,
tip of the tongue in the same doses and
timing as the KMC group or severe pain scores between
KMC: Mothers provided KMC to diaper-clad groups at all time points (30, 60,

infants on their bare chest for at least 90, and 120 seconds)
15 minutes. Two minutes before heel
lance, infants received one-fourth of the
recommended amount (0.4e1.0 mL based
on body weight) of sterile water on their
tongue, then received the remaining dose
in small volumes during the procedure
KMC þ sucrose: The procedure is the same
as the KC group, except infants received
24% oral sucrose solution instead of sterile
water
Carbajal et al. (2003)46

Control: Infants were laid on a table in a Activate Patient
supine position. Two minutes before Practical management activities Pain scores were lower during
venipuncture, they were given sterile water venipuncture in breastfeeding
(1 mL) group compared with control
Held by mother: Infants were held in their
mother’s arms without being breastfed group and when infants were only
starting two minutes before venipuncture held in mother’s arms, but no

Breastfeeding: Infants were breastfed difference in scores between
starting two minutes before venipuncture breastfeeding and glucose groups.
and continued during the procedure There was no difference in scores
Oral glucose: Infants were laid on a table in a between infants who were held by
supine position. Two minutes before their mothers and the control
venipuncture, they were given 30% group, but scores were lower in the
glucose (1 mL) and then a pacifier
glucose group compared with
control group
Castral et al. (2008)47 Control: Infants lay in the crib or incubator Activate Patient
in a lateral decubitus position, where their Practical management activities Pain scores were lower at the time of
heads were raised by a cloth diaper. They heel prick, 2.47 (SE 0.486), and
remained in this position during and after heel squeezing, 2.37 (SE 0.530) in
heel prick
the intervention group compared

Intervention: After a two-minute baseline
phase, infants received KMC from the with control group (heel prick:
mother for 15 minutes. Mothers wore 3.61; heel squeeze: 4.24). Crying
front-opening gowns and held the infant duration was lower in the
directly to their chest at a 60 angle. intervention group (2.5 minutes)
Infants only wore a diaper, and its back was compared with control group
covered by a blanket. Mothers remained (4.8 minutes)
seated with the infant before and after
heel prick (two minutes) but stood with
reserved.
the infant during heel prick

Chermont et al. (2009)48 Control: Infants were placed on their back in Activate Patient
the crib beside their mother. They Practical management activities During the injection, the combined
received sterile water (1 mL) on the intervention group was most
anterior portion of the tongue two effective in reducing pain. NIPS
minutes before intramuscular injection of
hepatitis B vaccine. They remained in this and NFCS pain scores were lower in
position for two minutes after the the combined group compared
procedure with control group, KMC alone,
KMC: Infants started KMC two minutes and dextrose alone. There was no
before intramuscular injection of hepatitis difference in pain between KMC
B vaccine. They also received sterile water alone and control, and dextrose
(1 mL) at this time on the anterior portion alone and control, according to
of the tongue. KMC was maintained for NIPS and NFCS scores. PIPP scores
two minutes after vaccination
Oral dextrose: Infants were placed on their indicated that scores were lower in
back in the crib beside their mother. They a group with KMC, both alone or
received 25% dextrose (1 mL) on the combined with dextrose
anterior portion of the tongue two Two minutes after the injection, all
minutes before intramuscular injection of three pain intervention groups had
hepatitis B vaccine. They remained in this reduced pain scores (NIPS and
position for two minutes after the NFCS) than the control group,
procedure with the combined group being the
Combined KMC and dextrose: Infants
started KMC two minutes before most effective. The order of
intramuscular injection of hepatitis B effectiveness from most to least is as
vaccine. They also received 25% dextrose follows: combined, KMC alone, and
solution (1 mL) at this time on the dextrose alone
anterior portion of the tongue. KMC was
1046.e9
maintained for two minutes after
vaccination
(Continued)
Appendix IV
1046.e10
Continued
49
Chidambaram et al. (2014) Control: Pain was measured 15 minutes Activate Patient
before heel prick and then 15 and Practical management activities Mean PIPP score difference between
30 minutes after the procedure baseline and 30 minutes after heel
Intervention: KMC was carried out for prick was lower in intervention
15 minutes, and then, heel prick was
conducted. Similar to control, pain was group, 0.1 (1.24), compared with
measured 15 minutes prior heel prick, control, 0.8 (2.08). There were
then 15 and 30 minutes after procedure no differences in mean heart rate
and oxygen saturation levels
Dezhdar et al. (2016)50 Control: Routine care Activate Patient
KMC: The neonate, with a clean diaper and Practical management activities KMC and swaddling were effective in
socks, was placed in contact with the reducing pain score during the
mother’s chest with the head at a 60 procedure, but there was no
angle. A thin blanket covered the
neonate’s back, and the mother was asked difference in pain scores between
to wrap her hands around the neonate’s the two interventions. Heart rate
back to prevent the neonate’s body was lower in the KMC and
temperature from reducing. After swaddling groups compared with
10 minutes, blood sampling was done control group, with no difference
from the neonate’s hand. The neonate’s between the two groups. Oxygen
face was videorecorded during blood saturation levels were higher in the
sampling and two minutes afterward. After
blood sampling, the neonate remained in KMC and swaddling groups
compared with control group
Yasmeen et al.
KMC for two more minutes
reserved.
Swaddling: The neonate with a clean diaper

was swaddled by a thin sheet by the
researcher for 10 minutes, and then a
hand was removed from the swaddle for
blood sampling. The neonate’s face was
videorecorded for two minutes during this
time. The neonate’s hand was returned in
the swaddle and kept there for two
minutes
Fallah et al. (2017)51 KMC: Infants received KMC for 10 minutes Activate Patient
before BCG vaccination, during, and Practical management activities During the procedure, pain score in
continued for one minute after the the breastfeeding group was lower
procedure. Infants were only wearing a than KMC and swaddling. This
diaper and were in skin-to-skin contact
with the mother under her gown, between trend was maintained two minutes
her bare breasts after vaccination. Duration of
Swaddling: Infants were swaddled for crying during vaccination was also
10 minutes before BCG vaccination, lower in the breastfeeding group
during, and continued for one minute than KMC and swaddling groups
after the procedure. Their hip and knees

were wrapped in the blanket with mild
tightness, and their hands and feet were
free
Breastfeeding: Infants started breastfeeding
two minutes before BCG vaccination,
during, and continued to for one minute
after the procedure
Franck et al. (2011)52 Control: As part of usual care, parents in Inform Caregiver
both groups received booklet containing Condition and treatment education At one week, there was no difference
generic information about NICU care, Activate in stress between control and
titled Parent Information Guide. Parents Practical management activities intervention groups. At three
were visited by the research nurse twice so
parents can share about their NICU Collaborate months, there was no difference in
experience, which was an attention Communication with providers role attainment or confidence and
placebo competency in caregiving scores
Intervention: In addition to the generic between groups
booklet, parents received a booklet
containing evidence-based information

about pain and comforting infants in the

NICU, titled Comforting Your Infant in
Intensive Care. The booklet contains
information on five topics: 1) how acute
pain happens and how it can affect
infants; 2) how pain is assessed and
managed in NICU; 3) role of parents in
providing comfort; 4) comforting
techniques with specific instructions; and
5) advice on parent communication with
NICU staff to optimize infant comfort. A
research nurse visited parents twice and
demonstrated comfort techniques.
Parents were encouraged to ask for the
nurse if they needed further instruction

Franck et al. (2012)53 (same study as Control: As part of usual care, parents in Inform Caregiver (qualitative)
previous publication but reporting both groups received booklet containing Condition and treatment education Parents in both groups viewed their
different outcomes) generic information about NICU care, Activate involvement in infant pain care
titled Parent Information Guide. Parents Practical management activities being vital and wanted to be fully
were visited by the research nurse twice so
parents can share about their NICU Collaborate involved
experience, which was an attention Communication with providers There were differences in what the
placebo parents wanted to know about
Intervention: In addition to the generic infant pain. Control parents were
reserved.
booklet, parents received a booklet interested in knowing how infants

containing evidence-based information felt pain and if it was different from
about pain and comforting infants in the adults, which medical procedures
NICU, titled Comforting Your Infant in caused pain, recognition of pain,
Intensive Care. The booklet contains
information on five topics: 1) how acute available options for pain
pain happens and how it can affect prevention, and how they can be
infants; 2) how pain is assessed and involved in comforting their
managed in NICU; 3) role of parents in infants. Intervention parents
providing comfort; 4) comforting wanted to know about the long-
techniques with specific instructions; and term effects of infant pain (such as
5) advice on parent communication with being more sensitive or tolerant to
NICU staff to optimize infant comfort. A
research nurse visited parents twice and pain) and how they can treat pain
demonstrated comfort techniques. at home postdischarge
Parents were encouraged to ask for the Both groups gave suggestions for
nurse if they needed further instruction improving infant paint
management. Both groups
recommended improving when
information is given to parents and
opportunities for involvement for
parents, but those in the
intervention group gave more
specific suggestions. Another
suggestion given by both groups
was increased sensitivity of nurses
in pain management and
1046.e11
consistency in pain management
techniques between staff
(Continued)
Appendix IV
1046.e12
Continued
54
Freire et al. (2008) Control: Infants in the incubator were Activate Patient
placed in a prone position and elevated at Practical management activities Pain scores and heart rate variation
30 e45 10 minutes before heel lance were lower in the KMC group
KMC: Infants started KMC 10 minutes before compared with control and oral
heel lance. They received skin-to-skin
contact with the mother’s chest, which was glucose groups 30 seconds after
covered with a sheet to maintain blinding heel lance. Transcutaneous oxygen
of recorders saturation levels were lower in the
Oral glucose: Similar to the control group, KMC group compared with the
infants in the incubator were placed in a control group 30 seconds after heel
prone position at 30 e45 elevation. They lance
received oral glucose (1 mL) at the
anterior portion of their tongue two
minutes before heel lance
Gabriel et al. (2008)55 Control: Infants received sucrose only Activate Patient
during the endocrine metabolic test. Practical management activities More infants in the intervention
Infant was prepared by warming the heel group were assessed to have mild
with hot water contained in a glove. Infant pain (score 0e3) than control, but
was placed in a cradle or incubator in a
supine position. Sucrose (20%, 0.5e2 mL) this was not statistically significant
was administered one minute before test
with a pacifier or teat
Intervention: Infants received KC with
Yasmeen et al.
sucrose during the endocrine metabolic
reserved.
test. Infant was prepared by warming the

heel with hot water contained in a glove.
Infant was in KC position for a minimum
of 30 minutes before test. The infant was
in prone position, wearing a diaper and
cap, and placed on the parent’s anterior
thoracic. Sucrose (20%, 0.5e2 mL) was
administered one minute before test with
a pacifier or teat. Infant remained in KC
position after test
Gao et al. (2015)56 Control: Infants were placed in the Activate Patient
incubator wearing a diaper and in a prone Practical management activities Across the three repeated heel sticks,
position with the head angled at a 30 e crying duration, facial grimacing,
40 incline. They remained in this and heart rate were lower in the
position for 30 minutes before heel stick,
blood collection, and then underwent a intervention group from the blood
recovery phase (two minutes collection phase to recovery phase
postprocedure). Mothers were not present compared with control group. Less
Intervention: An NICU nurse transferred the infants cried (12%) in the
infant from the incubator to the mother intervention group compared with

who was in her bed next to the incubator. control group (60%). Less infants
The mother was wearing a front-opening grimaced in the intervention group
gown, and the infant was wearing a diaper. (14%) compared with control
After establishing skin-to-skin contact
between the mother and infant, the infant group (69%)
was covered with a blanket. They remained
in this position for 30 minutes before heel
stick, blood collection, and then during
the recovery phase (two minutes
postprocedure). After this, the mother
could continue KMC, or the nurse
transferred the infant back to the
incubator
Gray et al. (2000)57 Control: Infants were wrapped in a blanket Activate Patient
and laid down on their side in their Practical management activities
bassinet before heel stick Duration of grimacing and crying
Intervention: Mothers reclined at 45 and
during heel prick was less in the

provided KMC to infants who were only
intervention group compared with

wearing a diaper. They maintained this
position for 10e15 minutes before heel control group. KMC reduced
prick grimacing by 65%, and crying by
82%, compared with control group
Gray et al. (2002)58 Control: Standard of caredblood was Activate Patient
collected while the baby was swaddled in a Practical management activities Infants in the intervention group
blanket in their bassinet and placed on its cried for 4% of the heel lance
side. A heel warmer was given to the infant procedure, with mean duration of
for a two-minute baseline period, after
which it was removed. After heel lance 8.77 seconds. This was lower than
procedure, there was a two-minute control group, where infants cried
recovery phase for 43% of the time with mean
Intervention: Blood was collected while the duration of 80.31 seconds. Mean
infant was breastfeeding. The infant, increase in heart rate was lower in
wearing a diaper, was given to the mother the intervention group (6 bpm)

who was reclined and held the infant compared with control group (29
during breastfeeding for full-body and
skin-to-skin contact. A lactation consultant bpm)
provided assistance with positioning and
assessment of suckling. Once the infant
had a good latch, the mother and infant
were covered with two blankets so only one
side of the infant’s face was visible for
filming. A heel warmer was given to the
reserved.
infant for a two-minute baseline period,

after which it was removed. After heel
lance procedure, there was a two-minute
recovery phase
Hashemi et al. (2016)60 Control: Standard of care with no Activate Patient
intervention Practical management activities Mean pain score in the first
Breastfeeding: Infants were breastfed within 15 seconds after vaccination was
45 minutes before BCG vaccination and lower in the breastfeeding,
not swaddled
Swaddling: Infants were swaddled a few swaddling, and combined groups
minutes before BCG vaccination and than control
remained so a few minutes after the Heart rate change at the moment of
procedure. More than 45 minutes had injection was lower in the
passed since they were breastfed breastfeeding, swaddling, and
Combined (breastfeeding and swaddling): combined groups compared with
Infants were breastfed within 45 minutes control group. There were no
before BCG vaccination. They were also
swaddled a few minutes before vaccination between-group differences in
and remained so for a few minutes after blood oxygen saturation levels at
the procedure the moment of injection
There were no between-group
differences in heart rate change
and blood oxygen saturation two
minutes after vaccination
Hudgens (1979)59 Intervention: In the family oriented Activate At two-year follow-up, 75% (n ¼ 18 of 24) of
treatment program, caregivers were taught families retained gains of the program
operant conditioning techniques that Practical management activities (e.g., satisfactory family relationships,
1046.e13
rewarded nonpain-oriented behavior of exercise and activity, no prescription pain
the patient. The program ran during the
(Continued)
Appendix IV
1046.e14
Continued
patient’s inpatient stay that lasted seven to medications, and normal use of the health
nine weeks and then continued during an care system
outpatient period of one to five weeks. Patient (qualitative)
Caregivers came to the hospital two to
three times a week and met with the social
worker to train on ignoring pain-related About 83% of patients (n ¼ 20 of 24)
behavior in patients and reinforce health- returned to some type of useful
related behavior. Afterward, the patient work. By the end of the program,
and caregiver were interviewed on how to pain medications given to patients
maintain well behaviors and the transition were reduced to zero. Despite this,
to the home environment. The hospital all patients showed activity level
staff worked with the patient to ignore that was normal for their age/sex at
pain behaviors and reinforce well time of discharge, and their
behaviors. Pain medications were given to exercise tolerance had also
the patient until slowly, over time, none
were given. Outcomes were measured increased
before and after the intervention Caregiver (qualitative)
Family relationship improved, with
75% (n ¼ 18 of 24) of families
reporting an increase in recreation
and leisure time spent with family
Health system (qualitative)
About 83% (n ¼ 20 of 24) of patients
Yasmeen et al.
and families were using the health
reserved.
care system appropriately

Huth et al. (2003)61 Control: Standard of care regarding Inform Patient
postoperative care Condition and treatment education There were no between-group
Intervention: Parents were given an age- Activate differences in pain scores rated by
appropriate booklet (Where does it hurt? Physiological monitoring the child or parent. Pain ratings by
Pain assessment and management for parents)
on pain assessment and management of Collaborate the parent decreased within
preschool, school-age, and adolescent Communication with providers control and intervention groups
children. The booklet was given before the Caregiver
child’s surgery, and a study team member There were no differences in parents’
provided a teaching session on the day of attitude about pain medication
or day after surgery. Information was between control and intervention
provided on the definition of pain, child’s groups. Within the intervention
reaction to pain, assessment of child’s group, parents’ attitude scores
pain, management of pain with
medication, and nonpharmacological increased compared with baseline
methods of pain management. Parents
used a Parent Diary to record information,
including parent and child pain ratings,

nonpharmacological strategies to alleviate
pain, frequency and level of comfort in
communicating with health care team
about child’s pain, satisfaction with pain.
They were asked to complete the diary two
times a day for the first three days after
child’s surgery or until discharge,
whichever came first. A study team
member visited the parent and child once
daily to ensure diaries were being
completed and to answer any questions.
On day of discharge, parents were asked to
evaluate the booklet
Jenkins et al. (2019)62

Control: Parents did not receive the NP-TIPS Inform Patient
intervention
Intervention (NP-TIPS): A multidisciplinary Condition and treatment education Children in the intervention group
team (clinical and research nurses, Activate had less pain than children in the
pediatric psychologists, and pediatric
Practical management activities control group (P ¼ 0.001)

anesthesiologists) designed the NP-TIPS.
A literature search identified target parent Caregiver

behaviors that were less likely to distress Parents in the intervention group
children (e.g., distraction, coping advice) increased their rate of desired
and nondesired behaviors that were more behaviors by 124% (P ¼ 0.033;
likley to distress children (e.g., empathy, Cohen’s d ¼ 0.61)
reassurance, apology). The research team Parents in the intervention group
taught target behaviors to nurses through decreased their rate of nondesired
a group training seminar, followed by
individual coaching and feedback. In the behaviors by 26%, but it was not
hospital waiting room, parents accessed a statistically significant (P ¼ 0.494;
web module with education text, video, Cohen’s d ¼ 0.19)
and printer-friendly information page Provider
about desired and nondesired behaviors. Nurses statistically significantly
In the PACU, nurses trained parents by increased their rate of desired
instructing them to engage in distraction behaviors by 231% (z ¼ 3.233;

and coping advice and avoid apology, P ¼ 0.001; Somer’s D ¼ 1) and
empathy, and reassurance with the decreased their rate of nondesired
children. Nurses provided rationales
behind these behaviors and examples of behaviors by 62% (z ¼ 2.888;
target behaviors P ¼ 0.004; Somer’s D ¼ 0.88; 95%
CI [1.74, 0.03])
Johnston et al. (2003)63 Based on the crossover design, each infant Activate Patient
underwent heel lance procedure twice, Practical management activities Pain scores were lower in the
once in KMC and another in standard of intervention group at the following
reserved.
care while lying in the isolette. There was a time points after heel lance
minimum of 24 hours and maximum of
seven days between the two heel lance procedure: 30 seconds (mean
procedures. The order of the condition difference 1.5 points; P ¼ 0.04),
was randomly assigned by a computer- 60 seconds (mean difference 2.2
generated program points; P ¼ 0.002), and 90 seconds
Control: The infant was lying in the isolette (mean difference 1.8 points;
in a prone position and swaddled with a P ¼ 0.02). Scores were not different
blanket for 30 minutes until heel lance between groups 120 seconds after
Intervention: The mother provided KMC by heel lance: mean difference 0.6
holding the infant in a diaper upright at
an angle of 60 between the mother’s points, P ¼ 0.37
breasts. The infant’s back was covered with There was no difference in change in
a blanket, and the mother’s clothes were heart rate and oxygen saturation
wrapped around the infant. The mother levels between groups
wrapped her hands around the infant’s
back and was asked not to talk to the
infant or touch the infant’s face so coders
remained blinded. KMC was maintained
for 30 minutes before heel lance started
Johnston et al. (2008)64 Infants served as their own controls in this Activate Patient
crossover study Practical management activities Between control and intervention
Control: The infant was placed in the groups, pain score was significantly
incubator in a prone position and was lower in intervention group
swaddled with a blanket. The baby was
kept in this position for 15 minutes. The (P < 0.001) at 90 seconds. Scores
heel lancing procedure began. All this was were insignificant at all other time
videotaped but not audiotaped points (30, 60, and 120 seconds)
1046.e15
Intervention: The neonate, wearing a diaper,
was held by the mother between her
(Continued)
Appendix IV
1046.e16
Continued
breasts for maximum skin contact, at an Infants returned to baseline heart

approximate angle of 60 . A blanket and rate quicker (123 seconds) than
then the mother’s clothes were placed on those in control (193 seconds)
the infant’s back. The mother was asked to
clasp her hands behind the infant and to
not touch the infant’s head or face. The
baby was held in this position for
15 minutes. The heel lancing procedure
began. All this was videotaped but not
audiotaped
Johnston et al. (2009)65 KMC: Infants received KMC during heel Activate Patient
lance while only wearing a diaper and Practical management activities There were no differences in mean
placed in an upright position at 60 pain scores and time for heart rate
between the mother’s breasts. A blanket to return to baseline between
covered the infant, which was then
covered by the mother’s clothes and then groups at all time points
tucked under each side of the mother.
KMC started 30 minutes before heel lance
and continued during the procedure
EKMC: Infants received KMC while the
mother sat on a rocking chair, sang or
talked to the baby (baby talk), and she
offered her finger or pacifier to the baby
Yasmeen et al.
to suck. EKMC started 30 minutes before
reserved.
heel lance and continued during the

procedure
Johnston et al. (2011)66 Intervention: Both parents (mother and Activate Patient
father) for each infant participated in the Practical management activities Between mother KC and father KC,
study, with each infant acting as its own pain scores were lower in mother
control. Eligible infants had to undergo at KC at 30 seconds, mean difference
least two blood samplings. Each parent
provided KC in separate blood sampling 1.435 (95% CI 0.232e2.632), and
occasions, and the order was randomly at 60 seconds, mean difference
determined by the secure computer Web 1.548 (95% CI 0.069e3.027)
site. The assigned parent provided KC for
at least 15 minutes before heel lance, and
then the position was maintained during
and after heel lance for at least 15 minutes
Kashaninia et al. (2008)68 Control: Infants were in a quiet room and Activate Patient
left for 10 minutes so they could relax. Practical management activities Pain scores were lower in the
Intramuscular injection of vitamin K was intervention group immediately
administered afterward after intramuscular injection of
Intervention: Infants received KMC while
wearing a diaper only, and the mothers vitamin K compared with control

inclined at 46 angle. Mothers wore a group (6% [n ¼ 3] of infants in the
front-opening gown, and the infant was intervention group were in severe
covered with blankets. Mothers were asked pain compared with 60% [n ¼ 30]
not to talk or caress the infant during in the control group). Cry duration
KMC. They were left along for 10 minutes after injection was lower in the
to relax, and then the infants were intervention group (14.55 [19.88]
administered intramuscular injection of
vitamin K seconds, compared with control
group, 24.61 [16.39] seconds)
Khodam et al. (2002)69 Control: Infants were swaddled in the crib Activate Patient
before, during, and for three minutes after Practical management activities The duration of crying in the
intramuscular injection intervention group three minutes
Intervention: Infants received KMC by being after the injection was lower
in direct skin-to-skin contact with their ([25.5 seconds]) compared with
mothers. Mothers were asked to not do the control group (38.2 seconds)
anything extra such as speak and pat the There were no differences in change
infant. Infants remained in this position
for two minutes before the intramuscular in heart rate and oxygen saturation
injection, during, and for three minutes levels between intervention and
after the procedure control groups during or after the
injection
Khresheh (2010)67 Control: Standard of caredno female Activate Patient
companion/relative during labor Practical management activities In the intervention group, less
Intervention: Women who arrived to the mothers used pain relief during
hospital with a female companion were labor (45%) compared with the
assigned to the intervention group. The
female companion was allowed to stay with control group (98%). More
the mother in labor during the first stage mothers in the intervention group
of labor and instructed to support the rated their birth experience to be
mother by being affectionate, keeping her good (84%) compared with the
calm, and stimulating and encouraging control group (32%)
her
Kostandy et al. (2008)70 Control: Infants were placed in an incubator Activate Patient

while wearing a diaper. They were placed Practical management activities When KMC was offered on the first
in a prone position between rolled day, crying duration was shorter in
blankets on a mattress that was at a 30 e
40 incline. This position was maintained the intervention group during the
for 30 minutes before heel lance, during, recovery phase (20 minutes
and continued for 20 minutes during the postintervention), 5.83 seconds
recovery period. The second heel stick (7.63), compared with the control
occurred within 24 hours of the first group, 25.50 seconds (41.93)
Intervention: Infants received KMC for When KMC was provided on the
reserved.
30 minutes before heel lance, during, and second day, crying duration during
continued for 20 minutes during a the procedure in the intervention
recovery phase. KMC was provided while group, 55 seconds (55.53), was less
the infant was wearing a diaper and placed
in an upright position between the than the control group,
mother’s bare breasts. A blanket covered 96.17 seconds (92.42)
the infant’s back. The mother reclined in
a lounge chair during the process. The
second heel stick occurred within 24 hours
of the first
Kostandy et al. (2013)70 Control: After randomization, infants were Activate Patient
placed in their bassinet in the supine Practical management activities There was no difference between
position. They were taken to the nursery control and intervention groups in
with the investigator staying by their side. heart rate during the one-minute
They were given 10e15 minutes to relax
before being administered hepatitis B hepatitis B vaccine administered or
vaccine in the five-minute recovery phase.
Intervention: After randomization, infants There was no difference in crying
and their mothers were given 10e time between intervention
15 minutes to relax. Infants were placed in (23 seconds) and control
a prone position on their mother’s chest (32 seconds) groups during the
and received KMC while the mother procedure, but infants stopped
stayed on her bed. After the resting phase, crying sooner in the intervention
infants were administered hepatitis B
vaccine. During the procedure, mothers group compared with control
were allowed to speak to the infant, pat group. Fewer infants were in the
their back, or kiss the infant’s forehead to crying fussing state during the
calm them down procedure in the intervention
1046.e17
group (77%) compared with
(Continued)
Appendix IV
1046.e18
Continued
control group (95%). Infants in the

intervention group cried for a
shorter time (16 seconds) than
control group (72 seconds) during
the five-minute recovery phase
Kristoffersen et al. (2019)72 Control: Infants were randomized to either Activate Patient
groups as the first of two consecutive eye Practical management activities There was no statistically significant
examinations (screening for retinopathy difference in mean pain scores
of prematurity). The eye examination during the eye examination
occurred with the infant placed in a
supine position in an open incubator and between the intervention (mean
swaddled tightly in a blanket. Parents score ¼ 10.2) and control (mean
supported the infant’s arms and feet. score ¼ 10.3) groups (mean
According to standard care, infants were difference ¼ 0.1; 95% CI
given topical anesthesia (oxibuprokain [1.568, 1.396])
minims 4 mg/mL) on the eye and 24% Thirty seconds after the examination,
oral sucrose (0.2 mL) on the tongue with a there was no statistically significant
syringe two minutes before the difference in mean pain scores
examination, after which they were given
the option of a pacifier. During the between the intervention (mean
examination, the ophthalmologist score ¼ 7.0) and control (mean
inserted a speculum with methocel 2% score ¼ 6.8) groups (mean
contact lens coupling fluid to ensure the difference ¼ 0.2; 95% CI [1.09,
Yasmeen et al.
infant’s eyelids remained open. The 1.49])
reserved.
duration of the procedure ranged from 30

to 60 seconds
Intervention: Infants were randomized to
either groups as the first of two
consecutive eye examinations (screening
for retinopathy of prematurity). Thirty
minutes before the eye examination, a
parent provided KC to the diaper-clad
infant by placing the infant in a prone
position on the parent’s bare chest while
sitting in a recliner with a 30% incline. At
the time of examination, the infant was
turned to a supine position with the
parent cradling the infant while
supporting the arms and feet. According
to standard care, infants were given topical
anesthesia (oxibuprokain minims 4 mg/
mL) on the eye and 24% oral sucrose
(0.2 mL) on the tongue with a syringe two

minutes before the examination, after
which they were given the option of a
pacifier. During the examination, the
ophthalmologist inserted a speculum with
methocel 2% contact lens coupling fluid
to ensure the infant’s eyelids remained
open. The duration of the procedure
ranged from 30 to 60 seconds
Livingston et al. (2009)73 Control: Standard of care Activate Outcomes other than length of stay were not
Intervention: Infants received seven Practical management activities compared between groups because of
consecutive days of massage. Caregivers Collaborate small sample size
attended an hour-long massage class
taught by a nurse who is an infant massage Safety netting Caregiver (qualitative)
instructor. Then caregivers were asked to
attend minimum of three bedside massage Caregivers in both groups reported
instruction classes that were taught by a decreased depression symptoms at
CIMI. The CIMI demonstrated on a doll,
seven days compared with baseline.

then the infant in front of the caregiver. In
next sessions, caregivers were encouraged Caregivers in the intervention

to deliver massage. If they did not feel group were satisfied in their
comfortable or were not prepared to, the relationship with the infant and the
CIMI delivered intervention to ensure impact of the intervention. They
infants received seven consecutive days of were also satisfied with their
massage. Caregivers were carefully infants’ medical treatment and how
monitored by CIMI on their competency. the medical staff treated them
If by the end of the study period caregivers
did not meet all items on the caregiver Provider (qualitative)
competency checklist, they were offered CIMIs who participated in the
an additional bedside massage session program expressed high levels of
satisfaction with the massage
program, and nurses who
participated expressed moderate to
high levels of satisfaction regarding

the massage program
Health system
No difference in length of stay
between control (35.4 days; SD
39.1) and intervention (56.8 days;
SD 32.2) groups
Ludington-Hoe et al. (2005)74 Control: Infant was placed in the warmer Activate Patient
while wearing only a diaper for three
reserved.
hours during the interfeeding interval. Practical management activities Length of crying was less in the
The infant was in a prone position and intervention group during and five
lying between two blankets that were
rolled up to form a boundary on each side. minutes after heel stick compared
A blanket covered the infant. Heel stick with control group. Mean rise in
was performed while the infant was lying heart rate from baseline to heel
in the warmer. The position started stick was lower in the intervention
15 minutes before heel stick, during heel group compared with control
stick, and continued for five minutes after group
the procedure
Intervention: Infant received three hours of
KMC during the interfeeding interval,
after which the infant underwent heel
stick procedure while KMC was
maintained. During KMC, the infant was
wearing a diaper and placed in a prone
position between the mother’s breasts. A
blanket covered the back of the infant,
which was covered by the mother’s blouse.
The position started 15 minutes before
heel stick, during heel stick, and
continued for five minutes after the
procedure
Mehling et al. (2012)75 Control: Usual caredpharmaceutical Activate Patient
management of pain and nausea but no Practical management activities There were no between-group
massage or acupressure. Before discharge, differences in days of pain (during
both the parent and child were offered a intervention), pain score (one
single 20-minute massage in addition to a
1046.e19
$25 gift card for completing week), fatigue (one week),
questionnaires
(Continued)
1046.e20
Appendix IV
Continued
Intervention: While the child was in the postintervention depression and

hospital, two professional massage anxiety
practitioners gave 20e30 minutes of Caregiver
combined Swedish and acupressure
massage three times a week in the patient’s At patient discharge, there were no
room. The massages were between-group differences in
semistandardized and based on a manual. parents’ self-efficacy, post-traumatic
Parents were trained by the practitioners stress symptoms, and depression
on using acupressure by demonstrating on Health system
both the child and parent. An instruction
sheet was used for training, which Length of hospital stay was not
contained pictures and acupressure point different between groups
locations. Parents were encouraged to
provide additional acupressure on
children
Miles et al. (2006)76 Control: Standard nursing care Activate Patient
Intervention: Mothers provided KMC once Practical management activities There were no differences in pain
daily for 20 minutes during four weeks in Collaborate and distress at four-month and 12-
the NICU. Mothers sat on a chair at a 60
angle and wore a front-opening gown. Safety netting month vaccination periods
Infants wore only a nappy and woolen hat Caregiver
and were held by the mother in an upright There were no differences in stress
position between the mother’s breasts. A (discharge), maternal soothing
Yasmeen et al.
blanket covered the infant. The research (four-month), depression and
reserved.
coordinator made monthly follow-up anxiety (discharge, four-month, 12-

phone calls for support month), and attachment between
parent and child (12-month)
Mitchell et al. (2013)77 Control: Infants remained in the incubator Activate Patient
during the study period (five consecutive Practical management activities There were no differences in pain or
days from day of life 5e9). Parents were stress between groups
allowed to hold their infant for 15 minutes
daily if they wanted. Pain was assessed
during routine suctioning
Intervention: Infants received KC from the
mother or father daily for a minimum of
two hours during five consecutive days
(day of life 5e9). Pain was assessed during
routine suctioning
Mosayebi et al. (2014)78 In this crossover study, infants acted as their Activate Patient
own control. Washout period was between Practical management activities Pain scores were lower in the
one to four days intervention group during and two
Control: Infants were placed in the
incubator in a prone position. They were minutes after heel lance

swaddled with a blanket for 15 minutes
before heel lance procedure
Intervention: Infants received KMC while
wearing a diaper. They were held upright
at an angle of 60 between the mother’s
breasts and under her gown. A blanket
covered the infant’s back. They were in
this position for 15 minutes before heel
lance procedure started, and this position
was maintained during and two minutes
after the procedure
Nanavati et al. (2013)79

Control: Pain was assessed during adhesive Activate Patient
tape removal. No analgesic methods were Practical management activities Mean pain score in EBM and KMC
administered groups were lower compared with
KMC: Infants were in KMC for 15 minutes that in control group, but there
before the painful procedure (removal of
adhesive tape) were no differences between the

EBM: Infants received EBM through a swab two interventions. Change in heart
that was soaked in EBM and kept in the rate and oxygen saturation levels
infant’s mouth for two minutes before were not different across all groups
adhesive tape removal and remained in
the infant’s mouth during the procedure
Nimbalkar et al. (2013)80 In this crossover design, infants underwent Activate Patient
heel prick, once with KMC and once Practical management activities Mean pain score, pulse rate change,
under control conditions. Washout period and change in oxygen saturation
was a minimum of 24 hours and maximum levels were lower in the
of seven days
Control: Infants were lying in the cot in a intervention group compared with
prone position and swaddled in a blanket. control group
They remained in this position for
15 minutes before heel prick
Intervention: Infants received KMC for

15 minutes before heel prick, during, and
then for 15 minutes after the procedure.
The diaper-clad infant was held by the
mother between her breasts in a prone
position at an angle of 60 . A blanket
covered the back of the infant, which was
then wrapped over by the mother’s
clothes. The mother clasped her hands
around the infant’s back
reserved.
Noghabi et al. (2011)81 Control: Infants were wrapped with a blanket Activate Patient
and placed on the bed when they were Practical management activities Pain score was lower in the
injected intervention group compared with
Intervention: Infants received KMC while control group immediately after
only wearing a diaper when they were
injected. Mothers were positioned at a 45 infants received the injection. More
angle. They were instructed not to talk or infants cried in control group
caress the infant compared with the intervention
group
Okan et al. (2010)82 Control: Infants were placed in a supine Activate Patient
position on an examination table in a Practical management activities Pain scores, total cry duration, heart
silent nursery. They were wrapped in a rate, and oxygen saturation levels
blanket
KMC: Infants received KMC while wearing a were lower during the five minutes
nappy and with the mother reclining at a after heel prick in the KMC and
45 angle. The mother wore a front- combined groups compared with
opening gown, and infant was placed on control group. There were no
her chest with a blanket covering its back. differences between KMC and
KMC started 15 minutes before heel lance, combined groups
and mothers were allowed to touch and
nurse the infant
Combined (KMC and breastfeeding):
Infants received KMC and were breastfed
while wearing a nappy and with the
mother reclining at a 45 angle. The
mother wore a front-opening gown, and
the infant was placed on her chest with a
blanket covering its back. KMC started
1046.e21
15 minutes before heel lance, and
mothers were allowed to touch and nurse
the infant
(Continued)
Appendix IV
1046.e22
Continued
83
Pattangtanang et al. (2018) Control: Caregivers of children with cleft lip Inform Caregiver
and palate undergoing palatoplasty Condition and treatment education Caregivers in the intervention group
received conventional care without the Activate reported reduced mean state
preparation program. On the day of Practical management activities anxiety scores at post-test (34.10;
discharge, they were taught and
demonstrated postoperative methods to Physiological monitoring SD ¼ 4.48) compared with the
take care of their children Collaborate control group (48.55; SD ¼ 2.89).
Intervention: Caregivers participated in a Safety netting There were no statistically
preparation program where the significant differences in mean
researcher taught and demonstrated pretest scores between the two
methods for taking care of their children groups
with cleft lip and palate undergoing Caregivers in the intervention group
palatoplasty. Phase I: Through flip reported increased understanding
pictures, lectures, and demonstration,
they were educated and trained on fever of taking care of their children
management, proper posture, enhancing postsurgery at post-test (84.85;
comfort, and eating during the SD ¼ 2.11) compared with the
postoperative period. The duration of this control group (79.85; SD ¼ 1.79).
phase was 45 minutes. This was followed There were no statistically
by three follow-up assessments on the significant differences in mean
phone on caregivers’ knowledge and pretest scores between the two
preparation for surgery and reminding
them to keep records of their child’s pain. groups
Caregivers in the intervention group
Yasmeen et al.
Phase II: In the surgery phase, caregivers
reported increased understanding
reserved.
were monitored on caring for children

and record keeping from day of surgery of pain assessment and
(Day 0) to postoperative day (Day 1). management for their children at
Phase III: On the discharge day (Day 2), post-test (83.55; SD ¼ 1.82)
the researcher collected the pain compared with the control group
assessment forms and reviewed methods (69.60; SD ¼ 2.30). There was no
for taking care of the children with the statistically significant difference in
opportunity for caregivers to ask questions
mean pretest scores between the
two groups
Phillips et al. (2005)84 Breastfeeding: Mothers, while lying in their Activate Patient
postpartum bed and holding the infant, Practical management activities Infants who were breastfed had less
were given the option of breastfeeding change in mean heart rate
during heel-stick procedure
Pacifier mom (PacMom): Mothers, while compared with PacMom from
lying in their postpartum bed and holding before to after procedure
the infant, were given the option of Fewer infants cried in the
offering an unsweetened pacifier to the breastfeeding group (69%)
infant during heel stick procedure compared with PacOth (100%),
Pacifier other (PacOth): Research assistants but there was no difference

held infants in the bedside chair. They between breastfeeding and
were given the option of offering infants a PacMom groups and between the
pacifier during heel stick procedure two pacifier groups. Infants who
cried did so for longer duration in
the PacOth group (66%)
compared with the breastfeeding
(33%) and PacMom (45%) groups
Oxygen saturation levels did not
change across all groups
Rahmani et al. (2020)93

Control: Patients received routine care Inform Patient
Intervention: In the first session (the day
before surgery), the researcher educated Condition and treatment education Mean pain scores during the first
patients and the accompanying family Activate three days after surgery were lower
member on the content of an educational
Practical management activities in the intervention group

booklet, which included explanations of
the physiology of postsurgical pain, compared with the control group.

pharmacological treatments and their Day 1: interventiond5.22
complications, and nonpharmacological (SD ¼ 1.48), controld6.5
treatments (e.g., encouraging the patient (SD ¼ 1.30); Day 2:
to express fear and concern, and interventiond2.92 (SD ¼ 1.20),
relaxation methods like breathing controld4.81 (SD ¼ 1.32); and Day
techniques, distraction through television, 3: interventiond1.76 (SD ¼ .67),
reading books, talking, and music). The
second session occurred after surgery after controld3.39 (SD ¼ 1.53)
the patient was alert. It included reviewing
and encouraging the patient and family to
use nonpharmacological pain relief,
training them on how to use pain
measurement tools before requesting
sedatives, and correcting unrealistic

expectations of postsurgical pain
Saeidi et al. (2007)85 Control: Infants were wrapped in a blanket Activate Patient
and placed next to the mother’s bed when Practical management activities Pain scores and crying duration were
vaccinated lower during and three minutes
Intervention: Infants received KMC for
30 minutes before, during, and after after the intramuscular injection in
vaccination the intervention group compared
with control group
There were no differences in change
reserved.
in heart rate or oxygen saturation

levels between groups during after
the injection
Saeidi et al. (2011)86 Control: Infants were wrapped in a blanket Activate Patient
and placed near the mother’s bed when Practical management activities More patients in the control group
vaccinated scored 7 (on scale that ranges from
Intervention: The mother held the baby 0 to 7) compared with the
under her gown and between her breasts
so there was maximum skin-to-skin intervention group. Three minutes
contact. They remained in this position after the intervention, more
for two minutes, the baby was then patients in the intervention group
vaccinated, and then again they retained had a pain score of 0 (93.3%)
this position for three minutes. The baby’s compared with control group
face was videorecorded during this process (70%). There was no difference in
change in oxygen saturation levels
between groups during or after the
intervention
Samancioglu & Bakir (2019)94 Control: Caregivers provided a 60-minute Activate Patient
reading session to their patients Practical management activities In the intervention group, patient
Intervention: A certified reflexologist nurse Collaborate pain was reduced on the 15th day
taught caregivers how to apply foot Safety netting of receiving reflexology sessions
reflexology in a 60-minute teaching
session. Caregivers then applied 60-minute from the first day by 1.66 points
foot reflexology to their patients once a (SD ¼ 2.84). In the control group,
day for 15 days. Caregivers were given the patient pain had increased on the
opportunity to ask questions to the 15th day of the intervention
researcher compared from the first day by 0.70
1046.e23
points (SD ¼ 1.08)
(Continued)
Appendix IV
1046.e24
Continued
In the intervention group, anxiety

had reduced by 1.33 points
(SD ¼ 2.70) on the 15th day of the
intervention from the first day. In
the control group, anxiety scores
were not statistically different
between Day 1 and Day 15 of the
intervention
In the intervention group, fatigue
the control group, fatigue had
reduced by 1.13 points (SD ¼ 2.76)
on the 15th day of the intervention
from the first day
Caregiver
In the intervention group, burden
Yasmeen et al.
the control group, the burden
reserved.
score on the 15th day of the

intervention was not statistically
different from the first day (mean
difference ¼ 2.06; SD ¼ 7.86)
Savaşer (2000)87 Control: Infants were given a pacifier and Activate Patient
remained on the bed during heel stick Practical management activities Mean scores two minutes after heel
Intervention: Mothers held infants in their stick were lower in the intervention
arms on their lap and calmed them down group, 3.1 (2.1), compared with
by shaking or caressing during heel stick
control group, 4.1 (1.8)
Seo et al. (2016)89 Control: Standard of care Activate Patient
Intervention: Infants received KMC for Practical management activities Pain score was lower in the KMC
10 minutes before blood sampling, during group during and two minutes
sampling, and then three minutes after after heel stick compared with
sampling
control group. Duration of crying
and mean heart rate were lower in
the KMC group compared with
control group. There was no

difference in oxygen saturation
levels
Sharek et al. (2006)90 Control: Standard of care Inform Patient
Intervention: The pain management Condition and treatment education Mean parental pain scores and pain
intervention had three components: 1) Activate scores from chart review per shift
preoperative parent education, 2) package Practical management activities during the first six postoperative
on postoperative nonpharmacological
pain management interventions, and 3) Collaborate days were lower in the intervention
standard pharmacological pain regimen. Social support group
1) Parents were given a 10-minute
presentation about pain issues, which
covered aspects on expectations around
pain control, physiological reasons why
pain is not managed more aggressively
with medication immediately in the
postoperative period, and stating
procedures that are likely to occur in the
first six postoperative days. During this

period, each family was assigned a trained

parent mentor, who met weekly with the
family. Participants received education
materials (e.g., handouts, pamphlets,
index cards) on pain control. Families
were also introduced to the child life
specialist who went over options for pain
management, particularly
nonpharmacological therapies. 2)
Components of the package included
regular consultation by the physical and
occupational therapy services, the child
life service and child psychiatry service if
needed, and the pain service, which
developed a patient-specific plan of

nonpharmacological interventions (e.g.,
hypnosis, positioning, swaddling,
acupuncture). 3) Pain medicine was
administered immediately in the
postoperative period, which was increased
if needed
Shukla et al. (2018)91 All participants received 2 mL of mother’s Activate Patient
EBM with a cup and spoon, which served Practical management activities Pain scores were lower in the KMC
as baseline pain control measure two and combined groups compared
reserved.
minutes before heel prick

Control: The neonate’s face was with control group, with KMC
videorecorded but not audiorecorded being the most effective method
KMC: Intervention started 10 minutes before for reducing pain. Scores were not
heel prick. KMC continued after heel different between music therapy
prick according to institutional protocol. and control groups
The neonate’s face was videorecorded but
not audiorecorded
Music therapy: Intervention started
10 minutes before heel prick.
Instrumental-Indian classical flute music
was played from mobile devices 2 feet
from the patient and at a sound level
between 35 and 45 dBA. Music therapy
continued for at least five minutes after
heel prick
Combined (KMC and music therapy):
Instrumental-Indian classical flute music
was played from mobile devices 2 feet
from the patient and at a sound level
between 35 and 45 dBA. Music therapy
continued for at least five minutes after
heel prick. KMC: KMC continued after
heel prick according to institutional
protocol. The neonate’s face was
videorecorded but not audiorecorded
Shukla et al. (2018)92 Control: Infants were given 24% sucrose Activate Patient
(0.2 mL) two minutes before the heel stick
1046.e25
Practical management activities
procedure The mean pain score was not
KMC: Mothers provided skin-to-skin care at statistically different between the
least 10 minutes before the heel stick control (8.1; SD ¼ 2.82) and KMC
(Continued)
Appendix IV
1046.e26
Continued
groups (7.74; SD ¼ 2.43); 95% CI

procedure, then continued during and

after the procedure according to the unit (1.40, 0.68)
protocol
Soltani et al. (2018)95 Breastfeeding: Infants received intervention Activate Patient
15 minutes before heel prick Practical management activities Pain scores were lower in the
KMC: Infants received KMC for 15 minutes breastfeeding group compared
before heel prick with all other groups. The order of
KMC þ ointment: The anesthetic agent
EMLA cream was applied to infants, and most effective pain management
they were receiving KMC for 15 minutes was as follows: breast milk feeding,
before heel prick 2 mL of oral 25T dextrose, KMC,
Oral 25% dextrose: Infants were given 2 mL and KMC with EMLA cream. There
of oral 25% dextrose 15 minutes before were no differences in heart rate or
heel prick oxygen saturation levels between
groups
Stephenson et al. (2007)88 Control: In addition to usual care, patients Inform Patient
received special attention by their partners Condition and treatment education After adjusting for preintervention
for 30 minutes. This was in the form of Activate pain, pain scores were lower in the
partners reading something that was
selected by the patients. After completion Practical management activities intervention group compared with
of data collection, reflexology treatment control group
was offered to these patients
Intervention: The intervention was a 30-
Yasmeen et al.
minute reflexology session, which is based
reserved.
on the idea that reflexing certain areas of

the feet and hands that relate to specific
glands and organs will relieve pain. The
first and last five minutes (total
10 minutes) were spent on relaxing
techniques when the outer edges of the
patient’s ankles were reflexed. About
15 minutes was spent on reflexing areas of
the feet that corresponded to organs or
parts of the body with patient self-reported
pain. About five minutes was spent on
reflexing the entire area of the feet so the
whole body was covered. The technique
was taught to partners by the primary
author, a trained and certified
reflexologist. Partners had the
opportunity to practice the technique on
the primary author or the patient, and
feedback was given by the primary author.

Partners could also have the technique
demonstrated on them by the primary
author. Partners were informed about
signs and symptoms of deep vein
thrombosis, in which case foot reflexology
was to be avoided
Taddio et al. (2018)96 Control: Mothers received a general Inform Patient
immunization pamphlet and general Condition and treatment education Mean scores of mother-reported
immunization video produced by the Activate infant pain during vaccinations in
Public Health Agency of Canada. After Practical management activities the pain pamphlet group (5.7;
discharge and one week before the
anticipated two-, four-, and six-month SD ¼ 2.2) and the combined pain
infant vaccinations, they received pamphlet and pain video group
automated reminders (5.6; SD ¼ 2.2) were lower than
Pain pamphlet: Mothers received a pain mean score of mothers in the
pamphlet containing specific information control group (6.0; SD ¼ 2.1)
about pain mitigation. They also received
a general immunization pamphlet and Caregiver

general immunization video produced by Mothers in the two pain education

the Public Health Agency of Canada, like groups had more positive
the control group. After discharge and perceptions about the importance
one week before the anticipated two-, four- of managing vaccination pain than
, and six-month infant vaccinations, they mothers in the control group
received automated reminders Mothers in the two pain education
Pain pamphlet þ pain video: Mothers groups reported higher scores on
received a pain pamphlet and pain video,
both containing specific information on the knowledge test than mothers in
pain mitigation. They were given 10e the control group
15 minutes to review provided materials Mothers in the two pain education
after randomization. Then the research groups had higher rates of targeted
assistant turned on the television in the pain management interventions
room to a parent-accessible channel to (e.g., breastfeeding, sucrose, or
access the video. They also received a topical anesthetics) during

general immunization pamphlet and vaccinations than the control
general immunization video produced by
the Public Health Agency of Canada, like group
the control group. After discharge and
one week before the anticipated two-, four-
, six-month infant vaccinations, they
received automated reminders
Zhu et al. (2018)97 Control: Parents will receive routine care, Inform Patient
which consists of general information on Condition and treatment education There were no differences in the
reserved.
pain management for their child Activate highest pain score in 24 hours after
Intervention 1: Parents received a pain Practical management activities the surgery or between 24 hours
management education intervention
consisting of a booklet and video with one Physiological monitoring and two weeks after the surgery,
hour of face-to-face teaching. These were between the three groups
provided three to seven days before their Caregiver
child’s surgery by the research assistant. Between the control and Intervention
The booklet included information on pain 1 groups, parents in Intervention 1
and postoperative pain, pain assessment, group showed greater knowledge
pharmacological methods for pain relief, on pain management
and nonpharmacological pain relief
methods. The 10-minute video was based There were no statistically significant
on the booklet and demonstrated differences in parents’ general
different pain medication types available attitudes toward pain management
postoperatively, and how to use different among the three groups
nonpharmacological pain relief methods. Between the three groups, there were
The research assistant went over the no statistically significant
booklet and video with the parents and differences in the use of pain relief
demonstrated each pain relief methods. strategies for their child’s
Within two weeks after the surgery, parents postoperative pain between
recorded information on their child’s
postoperative pain and the details of the 24 hours and two weeks after
pain management strategies parents used surgery
when their child complained of More parents in the two intervention
postoperative pain groups used nonpharmacological
Intervention 2: Parents received a pain methods than parents in the
management education intervention control group
consisting of a booklet and video without
1046.e27
Parents in Intervention 1 group used
the one hour of face-to-face teaching. nonpharmacological methods for
These were provided three to seven days
(Continued)
Appendix IV
1046.e28
Continued
before their child’s surgery. The booklet their child’s pain management
included information on pain and more frequently than parents in
postoperative pain, pain assessment, the control group. There were no
pharmacological methods for pain relief, statistically significant differences
and nonpharmacological pain relief
methods. The 10-minute video was based in the frequency of
on the booklet and demonstrated nonpharmacological methods used
different pain medication types available by parents between the two
postoperatively and how to use different intervention groups
nonpharmacological pain relief methods. There were no statistically significant
The research assistant reminded parents differences in parents’ satisfaction
to read the booklet, watch the video, and with pain management between
practice pain relief methods with their the three groups
child before the surgery. Within two weeks
after the surgery, parents recorded
information on their child’s postoperative
pain and the details of the pain
management strategies parents used when
their child complained of postoperative
pain
KMC ¼ kangaroo mother care; FTP ¼ facilitated tucking by parents; PIPP ¼ Premature Infant Pain Profile; NIPS ¼ Neonatal Infant Pain Scale; REM ¼ rapid eye movement; NREM ¼ nonrapid eye movement;
EMPOWER ¼ Effective Management of Pain: Overcoming Worries to Enable Relief; KC ¼ kangaroo care; NFCS ¼ Neonatal Facial Coding System; BCG ¼ Bacillus Calmette-Guerin; NICU ¼ neonatal intensive care
unit; NP-TIPS ¼ Nurse and Parent Training in Postoperative Stress; PACU ¼ postanesthesia care unit; EKMC ¼ enhanced kangaroo mother care; CIMI ¼ certified infant massage instructor; EBM ¼ expressed breast
Yasmeen et al.
milk.
reserved.

Appendix V
Frequency of Tools Used to Measure Pain and Whether Pain Was Reported to be Significant
Toola Author (Yr) Statistically Significant Improvement in Pain?
PIPP Akcan et al. (2009)37 Yes
Axelin et al. (2009)39 Yes
Campbell-Yeo et al. (2019)45 No
Chermont et al. (2009)48 Yes
Chidambaram et al. (2014)49 Yes
Dezhdar et al. (2016)50 Yes
Freire et al. (2008)54 Yes
Johnston et al. (2003)63 Yes
Johnston et al. (2008)64 No
Johnston et al. (2009)65 No
Johnston et al. (2011)66 Yes
Kristoffersen et al. (2019)72 No
Mitchell et al. (2013)77 No
Mosayebi et al. (2014)78 Yes
Nanavati et al. (2013)79 Yes
Nimbalkar et al. (2013)80 Yes
Seo et al. (2016)89 Yes
Shukla et al. (2018)91 Yes
Shukla et al. (2018)92 No
NIPS Axelin et al. (2009)39 Yes
Fallah et al. (2017)51 Yes
Gabriel et al. (2008)55 No
Kashaninia et al. (2008)68 Yes
Noghabi et al. (2011)81 Yes
Saeidi et al. (2007)85 Yes
Saeidi et al. (2011)86 Yes
Savaşer (2000)87 Yes
Soltani et al. (2018)95 Yes
NFCS Castral et al. (2008)47 Yes
Hashemi et al. (2016)60 Yes
Okan et al. (2010)82 Yes
Chart reviewdFLACC scale, Wong Baker Faces Jenkins et al. (2019)62 Yes
scale, Numerical Pain Rating Scale Sharek et al. (2006)90 Yes
VAS Rahmani et al. (2020)93 Yes
Samancioglu & Bakir (2019)94 Yes
Three-point observational scale Bauchner et al. (1996)41 No
BPI (short form) Stephenson et al. (2007)88 Yes
DAN scale Carbajal et al. (2003)46 Yes
Family Pain Questionnaire Cagle et al. (2015)44 Yes
HOOSdpain dimension Berthelsen & Kristensson (2017)42 No
Modified Behavioral Pain Scale Miles et al. (2006)76 No
Oucher Huth et al. (2003)61 No
Peds Quality of Life Scale Cancer ModuledPain Mehling et al. (2012)75 No
subscale
PIPP ¼ Premature Infant Pain Profile; NIPS ¼ Neonatal Infant Pain Scale; NFCS ¼ Neonatal Facial Coding System; FLACC ¼ Face, Legs, Activity, Cry, Consolability
scale; VAS ¼ Visual Analogue Scale; BPI ¼ Brief Pain Inventory; DAN ¼ Douleur Aigue Nouveau-ne; HOOS ¼ Hip Disability and Osteoarthritis Score.
a
Studies sorted by frequency of pain tools used, and then in alphabetical order.
reserved.
1046.e30
Appendix VI
ROB of Included Studies
ROB4: Blinding of
ROB1: Random ROB2: ROB3: Blinding Outcome Assessors ROB5: Incomplete

Sequence Allocation of Participants/ (Patient-Reported Outcome Assessment ROB6: Other ROB7: Selective Overall
Author (Yr) Generation Concealment Personnel Outcomes) (Short Term) Source Bias Reporting ROB
Akcan et al. (2009)37 Low Low High Low Low Low Unclear Low
Axelin et al. (2006)38 Unclear Unclear High Low Low Low Unclear Low
Axelin et al. (2009)39 Low Low High Low Low Low Unclear Low
Axelin et al. (2010)40 Unclear Unclear High Low Low Low Unclear Low
Bauchner et al. (1996)41 Unclear Unclear High High Low Low Unclear High
Berthelsen & Kristensson (2017)42 High High High High Low Low Unclear High
Burns et al. (2000)43 High High High High Low Low Unclear High
Cagle et al. (2015)44 Unclear Unclear High Low Low Low High Low
Campbell-Yeo et al. (2019)45 Low Low High Low Low Low Low Low
Carbajal et al. (2003)46 Low Low High Unclear Low Low Low Low
Castral et al. (2008)47 Low Low High Low Unclear Low Unclear Low
Chermont et al. (2009)48 Low Low High High Low Low Unclear Low
Chidambaram et al. (2014)49 Unclear Unclear High Unclear Low Low Unclear Unclear
Dezhdar et al. (2016)50 Low Low High Low Low Low Unclear Low
Fallah et al. (2017)51 Low Low High High Low Low Unclear Low
Franck et al. (2011)52 Low Unclear High High Low Low Unclear Low
Franck et al. (2012)53 Unclear Unclear High High Unclear Low Unclear Unclear
Freire et al. (2008)54 Unclear Low High Low Low Low Unclear Low
Gabriel et al. (2008)55 Unclear Unclear High Unclear Low Unclear Unclear Unclear
Gao et al. (2015)56 Low Unclear High Unclear Low Low Unclear Low
Gray et al. (2000)57
Yasmeen et al.
Unclear Unclear High High Low Low Unclear High
Gray et al. (2002)58
reserved.
Unclear Low High Low Low Low Unclear Low

Hashemi et al. (2016)60 Unclear Low High Low Low Low Unclear Low
Hudgens (1979)59 Unclear High High High Low Unclear Unclear High
Huth et al. (2003)61 Low Low High High Low Low High Low
Jenkins et al. (2019)62 High High High High Unclear Low Unclear High
Johnston et al. (2003)63 Low Unclear High Low Low Low Unclear Low
Johnston et al. (2008)64 Low Unclear High Low Low Low Unclear Low
Johnston et al. (2009)65 Low Unclear High High Low Low Unclear Low
Johnston et al. (2011)66 Low Low High Low Low Low Unclear Low
Kashaninia et al. (2008)68 Low Unclear High High Low Low Unclear Low
Khodam et al. (2002)69 Unclear Unclear High Low Unclear Unclear Unclear Unclear
Khresheh (2010)67 High High High High Low Low Unclear High
Kostandy et al. (2008)70 Low High High Unclear High Unclear Unclear High
Kostandy et al. (2013)71 Unclear Unclear High High Low Low Unclear High
Kristoffersen et al. (2019)72 Low Unclear Low Low Low Low Low Low
Livingston et al. (2009)73 Low Unclear High High Unclear Low Unclear High
Ludington-Hoe et al. (2005)74 Low Low High High Low Unclear Unclear Low
Mehling et al. (2012)75 Low Low High High Low Low Unclear Low
Miles et al. (2006)76 Unclear Unclear High Unclear Unclear Unclear Unclear Unclear
Mitchell et al. (2013)77 Low Unclear High High Low Low Unclear Low

Mosayebi et al. (2014)78 Low Low High Low Low Low Unclear Low
Nanavati et al. (2013)79 Low Low High High Low Low Unclear Low
Nimbalkar et al. (2013)80 Low Low High Low Low Low Unclear Low
Noghabi et al. (2011)81 Unclear Unclear High Low Low Unclear Unclear Unclear
Okan et al. (2010)82 Low Low High High Low Low Unclear Low
Pattangtanang et al. (2018)83 Unclear Unclear High Unclear Low Low Low High
Phillips et al. (2005)84 Low Low High High Low Low High Low
Rahmani et al. (2020)93 High High Unclear Unclear Unclear High Low High
Saeidi et al. (2007)85 Unclear Unclear High Low Unclear Unclear Unclear Unclear
Saeidi et al. (2011)86 Unclear Unclear High Low Unclear Unclear Unclear Unclear
Samancioglu & Bakir (2019)94 Low Unclear High High Low Low Low Low
Savaşer (2000)87 Unclear Unclear High Unclear Unclear Unclear Unclear Unclear
Seo et al. (2016)89

Unclear Unclear High Unclear Unclear Low Unclear Unclear
Sharek et al. (2006)90 High High High Unclear Low Low Unclear High
Shukla et al. (2018)91 Low Low High Low Low Low Unclear Low
Shukla et al. (2018)92 Low Low Low Low Unclear Low Low Low
Soltani et al. (2018)95
Unclear Low High Low Low Low Unclear Low

Taddio et al. (2018)96 Low Low Low Low Low High Low Low
Stephenson et al. (2007)88 Unclear Unclear High Unclear Low Low Unclear Unclear
Zhu et al. (2018)97 Low Low Low Unclear Unclear High Low High
ROB ¼ risk of bias.

reserved.
1046.e31
1046.e32
Appendix VII
Outcomes Stratified According to ROB
Caregiver Health System
ROB Patient Outcomes (All)a Patient Outcomes (Pain) Outcomes Provider Outcomes Outcomes
Low (n ¼ 36)37e40,44e48,50e52,54,56, 27b,37,39,40,44,46e48,50,51,54,56,58, 25b,37,39,44,46e 3b,44,94,96 d

58,60,61,63e66,68,72,74,75,77e80, 60,63,64,66,68,74,78e80,82,84,91,94e96 48,50,51,54,56,58,60,63,66,68,74,78e
2c,37,75
82,84,91,92,94e96 80,82,84,91,94e96 c,38,d,52,61,75
4
7c,45,61,65,72,75,77,92 8c,45,61,64,65,72,75,77,92
Unclear (n ¼ 11)49,53,55,69,76,81, 8b,49,69,81,85e89 7b,49,81,85e89 2c,53,76 d d
85e89
2c,55,76 3c,55,69,76
High (n ¼ 14) 41e43,57,59,62,67,70,
7b,57,62,67,70,71,90,93 7b,57,62,67,70,71,90,93 4b,41,62,83,97
1b,62
5c,41e43,d,59,97 4c,41e43,d,97 3c,42,59,d,73,d 2c,41,73,d 2c,59,d,73,d

71,73,83,90,93,97

a
b
c
No statistically significant effect of intervention.
d
Yasmeen et al.
reserved.

Appendix VIII
Summary of Findings for Outcomes Based on Intervention Type
Caregiver-Mediated Intervention
Tool Control Intervention (Author, Yr) (Author, Yr) Quality of Evidence (GRADE)
Caregiver-mediated pain interventions using the inform engagement strategy in hospitalized patients compared with control intervention
Patient or population: hospitalized patients
Intervention: inform caregiver-mediated interventions on pain (n ¼ 1)
Comparison: control, i.e., usual care, other intervention, no intervention
Outcome: Pain (patient)
Structured questionnaire (using 0e At two weeks, caregivers perceived At two weeks, caregivers perceived Low
10 scale) patients in the intervention group to patients in the intervention group to
be in more pain (mean score 5.7 [SE be in less pain (mean score 4.2 [SE
0.4]). No difference in pain perception 0.4]). No difference in pain perception
at the moment the survey was at the moment the survey was
44
administered (Cagle et al., 2015 ) administered (Cagle et al., 201544)
Outcome: Barriers (caregiver)
EMPOWER Pain Barriers Measure At two weeks, caregivers in the At two weeks, caregivers in the Low
intervention group reported decreased intervention group reported decreased

pain barriers (P ¼ 0.008) (Cagle et al., pain barriers (P ¼ 0.008) (Cagle et al.,
44
2015 ) 201544)
Outcome: Knowledge (caregiver)
FPQ Knowledge Subscale At two weeks, the intervention group At two weeks, the intervention group Low
showed increased knowledge related to showed increased knowledge related to
pain and pain management compared pain and pain management (mean
with control (mean score 2.54 [SE score 2.76 [SE 0.05]). This trend was
0.04]). This trend was maintained at maintained at three months (Cagle
three months (Cagle et al., 201544) et al., 201544)
reserved.
Caregiver-mediated pain interventions using the activate engagement strategy in hospitalized patients compared with control intervention
Intervention: activate caregiver-mediated interventions on pain (n ¼ 46)
Comparison: control, i.e., usual care, other intervention, no intervention
PIPP Pain score was higher in the control Pain score was lower in the intervention Low
group throughout all time points group throughout all time points
during the blood sampling (first during the blood sampling (first
minute ¼ 15.0, second minute ¼ 15.5, minute ¼ 7.0, second minute ¼ 4.0,
and third minute ¼ 15.0) and right and third minute ¼ 4.0) and right after
after blood sampling (first blood sampling (first minute ¼ 4.0 and
minute ¼ 12.5 and second minute ¼ 7) second minute ¼ 4.0) (Akcan et al.,
37
(Akcan et al., 2009 ) 200937)
Opioid: During pharyngeal suctioning Opioid: During pharyngeal suctioning
and heel stick, scores were not and heel stick, scores were not
different between groups different between groups
Oral glucose: During pharyngeal Oral glucose: During pharyngeal
suctioning, scores were higher in the suctioning, scores were lower in the
control group, 12.40 (SD 2.06), oral glucose group, 11.05 (SD 2.31),
compared with oral glucose. During compared with control group. During
heel stick, scores were higher in the heel stick, scores were lower in the
control group, 7.05 (SD 2.16) glucose group, 4.85 (SD 1.73)
Facilitated tucking: During pharyngeal Facilitated tucking: During pharyngeal
suctioning, scores were higher in the suctioning, scores were lower in the
control group, 12.40 (SD 2.06). During facilitated tucking group, 11.25 (SD
heel stick, scores were higher in the 2.47). During heel stick, scores were
control group, 7.05 (SD 2.16) (Axelin lower in the facilitated tucking group,
39
et al., 2009 ) 5.20 (1.70) (Axelin et al., 200939)
1046.e33
No statistically significant difference in No statistically significant difference in
percentage of infants reported as percentage of infants reported as
having mild, moderate, or severe pain having mild, moderate, or severe pain
(Continued)
Appendix VIII
1046.e34
Continued
scores between groups at all time scores between groups at all time
points (before and after heel lance) points (before and after heel lance)
(Campbell-Yeo et al., 201945) (Campbell-Yeo et al., 201945)
During the injection, scores were higher During the injection, scores were lower in
in the control group compared with the KMC alone and KMC combined
KMC alone and KMC combined with with dextrose groups compared with
dextrose (Chermont et al., 200948) control group (Chermont et al.,
200948)
Mean scores at 15 and 30 minutes were Mean scores at 15 and 30 minutes after
5.76 (SD 2.5) and 5.24 (SD 2.33) in the heel prick were 4.3 (SD 3.02) and 3.84
control group, which were higher than (SD 1.34), which were lower than the
the intervention group (Chidambaram control group (Chidambaram et al.,
et al., 201449) 201449)
Scores were higher in the control group Scores were lower in the KMC and
compared with KMC and swaddling swaddling groups compared with
groups (Dezhdar et al., 201650) control group but not different
between the two pain intervention
groups (Dezhdar et al., 201650)
Scores were higher in the control group Scores were lower in the KMC group
compared with the intervention group compared with control and oral
30 seconds after heel lance (Freire glucose groups 30 seconds after heel
et al., 200854) lance (Freire et al., 200854)
Yasmeen et al.
Scores were higher in the control group Scores were lower in the intervention
reserved.
compared with intervention group at group compared with control group at

the following time points after heel the following time points after heel
lance procedure: 30 seconds (mean lance procedure: 30 seconds (mean
difference 1.5 points; P ¼ 0.04), difference 1.5 points; P ¼ 0.04),
60 seconds (mean difference 2.2 60 seconds (mean difference 2.2
points; P ¼ 0.002), and 90 seconds points; P ¼ 0.002), and 90 seconds
(mean difference 1.8 points; P ¼ 0.02) (mean difference 1.8 points; P ¼ 0.02)
(Johnston et al., 200363) (Johnston et al., 200363)
Between control and intervention Between control and intervention
groups, the score was higher in the groups, the score was lower in
control group compared with intervention group (P < 0.001) at
intervention group (P < 0.001) at 90 seconds. Scores were insignificant at
90 seconds. Scores were insignificant at all other time points (30, 60, and
all other time points (30, 60, and 120 seconds) (Johnston et al., 200864)
120 seconds) (Johnston et al., 200864)
No difference in mean scores between No difference in mean scores between
KMC and EKMC groups at all time KMC and EKMC groups at all time
points (Johnston et al., 200965) points (Johnston et al., 200965)
Between mother KC and father KC, Between mother KC and father KC,
scores were lower in mother KC at scores were lower in mother KC at

30 seconds, mean difference 1.435 30 seconds, mean difference 1.435
(95% CI 0.232e2.632), and at (95% CI 0.232e2.632), and at
60 seconds, mean difference 1.548 60 seconds, mean difference 1.548
(95% CI 0.069e3.027) (Johnston et al., (95% CI 0.069e3.027) (Johnston et al.,
201166) 201166)
There was no statistically significant There was no statistically significant
difference in mean pain scores during difference in mean pain scores during
the eye examination between the the eye examination between the
intervention (mean score ¼ 10.2) and intervention (mean score ¼ 10.2) and
control (mean score ¼ 10.3) groups control (mean score ¼ 10.3) groups
(mean difference ¼ 0.1; 95% CI (mean difference ¼ 0.1; 95% CI
[1.568, 1.396]). Thirty seconds after [1.568, 1.396]). Thirty seconds after
the examination, there was no the examination, there was no
statistically significant difference in statistically significant difference in
mean pain scores between the mean pain scores between the
intervention (mean score ¼ 7.0) and intervention (mean score ¼ 7.0) and
control (mean score ¼ 6.8) groups control (mean score ¼ 6.8) groups
(mean difference ¼ 0.2; 95% CI (mean difference ¼ 0.2; 95% CI

[1.09, 1.49]) (Kristoffersen et al., [1.09, 1.49]) (Kristoffersen et al.,
201972) 201972)
Mean score after suctioning was 7.89 (SE Mean score after suctioning was 7.64 (SE
0.21) in the control group, which was 0.40) in the intervention group, which
not different from the intervention was not different from the control
group (P ¼ 0.59) (Mitchell et al., group (P ¼ 0.59) (Mitchell et al.,
201377) 201377)
Mean score was 9.12 (SD 3.02) in the Mean score was 5.81 (SD 2.69) in the
control group during heel lance and intervention group during heel lance
4.48 (SD 1.24) two minutes after heel and 3.71 (SD 1.10) two minutes after
lance. These scores were higher than heel lance. These scores were lower
the intervention group (Mosayebi than the control group (Mosayebi
et al., 201478) et al., 201478)
Mean score was 12.13 (SD 2.59) in the Mean score was 6.2 (SD 2.1) in the EBM

control group, which was higher than group and 5.92 (SD 1.89) in the KMC
EBM and KMC groups (Nanavati et al., group. Scores were lower than control
201379) group, 12.13 (SD 2.59), but not
different between the two pain
interventions (Nanavati et al., 201379)
Mean score was 10.23 (SD 4.59) in the Mean score was 5.38 (SD 3.25) in the
control group, which was higher than intervention group, which was lower
the intervention group (Nimbalkar than the control group (Nimbalkar
et al., 201380) et al., 201380)
reserved.
During blood sampling, score was 6.3 During blood sampling, score was 4.1
(SD 3.47), which was higher than the (SD 2.28), which was lower than the
intervention group. Scores were also control group. Scores were also lower
higher at one and two minutes after at one and two minutes after heel stick
heel stick (Seo et al., 201689) (Seo et al., 201689)
Mean score was 11.49 (SD 3.37) in the Mean scores were 7.67 (SD 3.93) in the
control group, which was higher than KMC with EBM group and 8.50 (SD
the KMC with EBM and combined 3.23) in the combined group. Scores
(KMC þ music therapy) groups. Scores for both groups were lower than the
were not different between control and control group, but there was no
music therapy groups (Shukla et al., difference between music therapy and
201891) control groups (Shukla et al., 201891)
The mean pain score was not statistically The mean pain score was not statistically
different between the control (8.1; different between the control (8.1;
SD ¼ 2.82) and intervention (7.74; SD ¼ 2.82) and intervention groups
SD ¼ 2.43; 95% CI [1.40, 0.68]) (7.74; SD ¼ 2.43; 95% CI [1.40,
groups (Shukla et al., 201892) 0.68]) (Shukla et al., 201892)
NIPS Opioid: During pharyngeal suctioning, Opioid: During pharyngeal suctioning,
there was no difference in scores there was no difference in scores
between groups. Score was higher in between groups. Score was lower in the
the control group than the opioid opioid group than the control group
group during heel stick during heel stick
Oral glucose: There were no between- Oral glucose: There were no between-
group differences during pharyngeal group differences during pharyngeal
suctioning and heel stick suctioning and heel stick
Facilitated tucking: Scores were higher in Facilitated tucking: Scores were lower in
the control group during pharyngeal the facilitated tucking group during
suctioning and heel stick (Axelin et al., pharyngeal suctioning and heel stick
1046.e35
200939) (Axelin et al., 200939)
(Continued)
Appendix VIII
1046.e36
Continued
in the control group compared with the combined group compared with
the combined KMC and dextrose control, KMC alone, and dextrose
groups. There was no difference alone groups. There was no difference
between KMC alone and control as between KMC alone and control
well as dextrose alone and control groups as well as dextrose alone and
groups. Two minutes after the control groups. Two minutes after the
injection, scores were higher in the injection, scores were lower in the
control group compared with all three three pain intervention groups
pain interventions (Chermont et al., compared with control group
200948) (Chermont et al., 200948)
During vaccination, the score was 3.48 During vaccination, the score was 1.81
(SD 0.96) in the swaddling group, (SD 1.16) in the breastfeeding group,
which was higher than the which was lower than the KMC (2.92
breastfeeding group. The score was [SD 1.34]) and swaddling (3.48 [SD
1.07 (SD 0.56) in the swaddling group 0.96]) groups (P ¼ 0.001). Two
two minutes after vaccination, and this minutes after vaccination, the score
was also higher than the breastfeeding was 0.31 (SD 0.1) in the breastfeeding
group (Fallah et al., 201751) group, which was lower than the KMC,
0.73 (0.36), and swaddling, 1.07 (SD
0.56) groups (P ¼ 0.04) (Fallah et al.,
201751)
During the endocrine metabolic test, During the endocrine metabolic test,
Yasmeen et al.
mean score was 2.81 (SD 2.11), which mean score was 2.51 (SD 1.42), which
reserved.
was not different from the intervention was not different from the control
group (Gabriel et al., 200855) group (Gabriel et al., 200855)
About 60% (n ¼ 30) of infants in the About 6% (n ¼ 3) of infants in the
control group were in severe pain intervention group were in severe pain
immediately after intramuscular immediately after intramuscular
injection, which was more than in the injection, which was lower than the
intervention group (P ¼ 0.001) control group (P ¼ 0.001) (Kashaninia
(Kashaninia et al., 200868) et al., 200868)
Scores were higher in the control group Scores were lower in the intervention
compared with the intervention group group compared with control group
immediately after infants received immediately after infants received
intramuscular injection (Noghabi intramuscular injection (Noghabi
et al., 201181) et al., 201181)
During the intramuscular injection, During the intramuscular injection, 70%
96.6% of infants had a score of 7 in the of infants in the intervention group
control group. Three minutes after the had a score of 7. Three minutes after
injection, 70.0% of infants had a score the injection, 93.3% of infants had a
of 0 in the control group. Scores score of 0. Scores indicated that infants
indicated that infants were in less pain in the intervention group were in less
in the intervention group (Saeidi et al., pain than the control group (Saeidi

200785) et al., 200785)
About 96.6% of infants in the control About 70% of infants in the intervention
group scored 7 during vaccination, group scored 7, which was lower than
which was higher than the intervention the control group. Three minutes after
group. Three minutes after the the procedure, 3.3% of infants scored
procedure, 16.6% of infants scored 7 7 and 3.3% scored 6, which was less
and 10.6% scored 6 in the control than the control group (Saeidi et al.,
group, which was more than the 201186)
intervention group (Saeidi et al.,
201186)
Mean score two minutes after heel stick Mean score two minutes after heel stick
was 4.1 (SD 1.8) in the control group, was 3.1 (SD 2.1) in the intervention
which was higher than the intervention group, which was lower than the
group (Savaşer, 200087) control group (Savaşer, 200087)
No control, comparison between three Mean scores for breastfeeding,
pain interventions (Soltani et al., KMC þ ointment, KMC, and oral 25%
201895) dextrose groups were 5.52 (SD 2.22),
7.37 (SD 1.95), 6.84 (SD 1.96), and

6.45 (SD 1.88), respectively. The

breastfeeding group had the lowest
score and lowest frequency of severe
pain (Soltani et al., 201895)
NFCS Score was 3.61 during heel prick and 4.24 Score was 2.47 (SE 0.486) during heel
during heel squeeze in the control prick and 2.37 (SE 0.530) during heel
group, which was higher than the squeeze in the intervention group,
intervention group (Castral et al., which was lower than the control
200847) group (Castral et al., 200847)
in the control group compared with the combined group compared with
the combined KMC and dextrose control, KMC alone, and dextrose
groups. There was no difference alone groups. There was no difference
between KMC alone and control as between KMC alone and control
well as dextrose alone and control groups as well as dextrose alone and

groups. Two minutes after the control groups. Two minutes after the
injection, scores were higher in the injection, scores were lower in the
control group compared with all three three pain intervention groups
pain interventions (Chermont et al., compared with control group
200948) (Chermont et al., 200948)
Mean score in the first 15 seconds after Mean score in the first 15 seconds after
vaccination was higher in the control vaccination was lower in the
group compared with the breastfeeding (P ¼ 0.01), swaddling
breastfeeding (P ¼ 0.01), swaddling (P ¼ 0.001), and combined
reserved.
(P ¼ 0.001), and combined (P ¼ 0.002) groups compared with

(P ¼ 0.002) groups (Hashemi et al., control group (Hashemi et al., 201660)
201660)
Scores were higher during five minutes Scores were lower during five minutes
after heel prick in the control group after heel prick in KMC group
compared with the intervention group compared with control group (Okan
(Okan et al., 201082) et al., 201082)
PedsQL Cancer Module There was no difference in scores There was no difference in scores
between control and intervention between control and intervention
groups (Mehling et al., 201275) groups (Mehling et al., 201275)
Observational scale No difference in pain rating by parents No difference in pain rating by parents
or by clinicians between control, or by clinicians between control,
parental presence, and parental parental presence, and parental
intervention groups (Bauchner et al., intervention groups (Bauchner et al.,
199641) 199641)
DAN scale Scores were higher during venipuncture Scores were lower during venipuncture
in control group compared with in the glucose and breastfeeding
glucose and breastfeeding groups. No groups compared with control group.
difference in scores between infants No difference in scores between
who were held by their mothers and infants who were held by their mothers
control groups (Carbajal et al., 200346) and control as well as breastfeeding
and glucose groups (Carbajal et al.,
200346)
Outcome: Pain behavior (patient)
Observation of grimacing About 69% of infants grimaced during About 14% of infants grimaced during Low
heel stick in the control group, which heel stick in the intervention group,
was more than the intervention group which was lower than the control
(Gao et al., 201556) group (Gao et al., 201556)
1046.e37
Duration of grimacing during heel prick Duration of grimacing during heel prick
(Continued)
Appendix VIII
1046.e38
Continued
was higher in the control group was less in the intervention group
compared with the intervention group compared with control group. KMC
(P < 0.0001) (Gray et al., 200057) reduced grimacing by 65%
(P < 0.0001) (Gray et al., 200057)
Outcome: Pain relief (patient)
Observational About 93% of mothers (n ¼ 7521) did Of the mothers in labor who used Low
not use aromatherapy during labor aromatherapy, 7% (n ¼ 537) used it for
(Burns et al., 200043) pain relief. About 50% of mothers who
used aromatherapy rated it to be
helpful (Burns et al., 200043)
About 98% of mothers used pain relief About 45% of mothers used pain relief
during labor, which was higher than during labor, which was lower than the
the intervention group (Khresheh, intervention group (Khresheh, 201067)
201067)
Outcome: Crying (patient)
Observational No difference in crying control, parental No difference in crying control, parental Low
presence, and parental intervention presence, and parental intervention
groups (Bauchner et al., 199641) groups (Bauchner et al., 199641)
Crying duration was 4.8 minutes, which Crying duration was 2.5 minutes in the
was higher than the intervention intervention group, which was lower
group (Castral et al., 200847) than the control group (Castral et al.,
200847)
Yasmeen et al.
Crying duration was 63.25 (SD 16.98) Crying duration was 26.61 (11.7) seconds
reserved.
seconds in the swaddling group, which in the breastfeeding group, which was
was higher than the breastfeeding lower than the KMC group, 45.12
group (Fallah et al., 2017)51 (23.41) seconds, and swaddling, 63.25
(16.98), groups (P ¼ 0.001) (Fallah
et al., 2017)51
About 60% of infants in the control About 12% of infants in the intervention
group cried during heel stick, which group cried during heel stick in the
was higher than the intervention intervention group, which was lower
group (Gao et al., 201556) than the control group (Gao et al.,
201556)
Duration of crying during heel prick was Duration of crying was less in the
greater in the control group compared intervention group compared with
with the intervention group control group. KMC group reduced
(P < 0.0001) (Gray et al., 200057) crying by 82% (P < 0.0001) (Gray
et al., 200057)
Infants in the control group cried for Infants in the intervention group cried
43% of the heel lance procedure, with for 4% of the heel lance procedure,
mean duration of 80.31 seconds. This with mean duration of 8.77 seconds.
was higher than the intervention This was lower than control group
group (Gray et al., 200258) (Gray et al., 200258)

Cry duration after intramuscular Cry duration after intramuscular
injection was 24.61 (SD 16.39) seconds, injection was 14.55 (SD 19.88) seconds
which was longer than the intervention in the intervention group, which was
group (P ¼ 0.001) (Kashaninia et al., lower than the control group
2008)68 (P ¼ 0.001) (Kashaninia et al., 2008)68
The duration of crying three minutes The duration of crying three minutes
after the injection was 38.2 seconds in after the injection was 25.5 seconds in
the control group, which was higher the intervention group, which was
than the intervention group (P ¼ 0.02) lower than the control group
(Khodam et al., 2002)69 (P ¼ 0.02) (Khodam et al., 200269)
During the 20-minute recovery phase During the 20-minute recovery phase
after heel stick, cry duration was 25.50 after heel stick, cry duration was 5.83
(41.93) seconds in the control group, (7.63) seconds in the intervention
which was longer than the intervention group, which was shorter than the
group (Kostandy et al., 200870) control group (Kostandy et al., 200870)
During vaccination, cry duration was During vaccination, cry duration was
32 seconds in the control group, which 23 seconds in the intervention group,
was not different from the intervention which was not different from the
group. During the five-minute recovery control group. During the five-minute
phase after vaccination, cry duration recovery phase after vaccination, cry
was 72 seconds, which was longer than duration was 16 seconds, which was
the intervention group (0.007) longer than the control group (0.007)
(Kostandy et al., 201371) (Kostandy et al., 201371)
Cry duration was longer in the control Cry duration was shorter in the
group during (P ¼ 0.003) and five intervention group during (P ¼ 0.003)
minutes after heel stick (P ¼ 0.02) and five minutes after heel stick
compared with the intervention group (P ¼ 0.02) compared with the control
(Ludington-Hoe et al., 200574) group (Ludington-Hoe et al., 200574)
Total cry duration was higher during five Total cry duration was lower during five
minutes after heel prick in the control minutes after heel prick in KMC group
group compared with KMC and compared with control group. There
combined (KMC þ breastfeeding) was no difference between KMC and
groups (Okan et al., 2010)82 combined (KMC þ breastfeeding)

groups (Okan et al., 2010)82
More infants cried in the control group Fewer infants cried in the intervention
(88%) after intramuscular injection group (46%) after intramuscular
(Noghabi et al., 201181) injection (P < 0.001) (Noghabi et al.,
201181)
No control, comparison between three Fewer infants cried in the breastfeeding
pain interventions (Phillips et al., group (69%) compared with pacifier
200584) use by nonmother (100%). There was
no difference in number of infants
reserved.
who cried between the breastfeeding

group and pacifier use by mother
group and between the two pacifier
groups. Infants who cried did so for
longer duration in the pacifier use by
nonmother group (66%) compared
with the breastfeeding (33%) and
pacifier use by mother (45%) groups
(Phillips et al., 200584)
Outcome: Heart rate (patient)
Observational Mean duration of crying during the Mean duration of crying during the
intramuscular injection and three intramuscular injection was lower in
minutes after was higher in the control the intervention group compared with
group than intervention group (Saeidi the control group (Saeidi et al.,
et al., 200785) 200785)
Duration of crying during heel stick was Duration of crying was 17.7 (SD 38.92)
149.2 (SD 92.88) seconds in the seconds in the intervention group,
control group, which was longer than which was lower than the control
the intervention group (Seo et al., group (Seo et al., 201689)
89
Mean ) rate at 15 and 30 minutes
2016heart Mean heart rate at 15 and 30 minutes Low
after heel prick was 136 (SD 14.9) after heel prick was 141 (SD 11.6)
beats/minute and 135 (SD 14.6) beats/minute and 140 (SD 11.4)
beats/minute, which were not beats/minute, which were not
different from the intervention group different from the intervention group
(P ¼ 0.075) (Chidambaram et al., (P ¼ 0.075) (Chidambaram et al.,
201449) 201449)
Heart rate was higher in the control Heart rate was lower in the KMC and
1046.e39
group compared with KMC and swaddling groups compared with
swaddling groups (Dezhdar et al., control group but not different
201650) between the two pain intervention
(Continued)
Appendix VIII
1046.e40
Continued
50
groups (Dezhdar et al., 2016 )
Heart rate variation was greater in the Heart rate variation was less in the KMC
control group compared with KMC group compared with oral glucose and
group 30 seconds after heel lance control groups 30 seconds after heel
(Freire et al., 200854) lance (Freire et al., 200854)
Heart rate was higher in the control Heart rate was lower in the intervention
group during heel stick compared with group during heel stick compared with
the intervention group (Gao et al., control group (Gao et al., 201556)
201556)
Mean increase in heart rate was 29 beats/ Mean increase in heart rate was six beats/
minute, which was higher than the minute in the intervention group,
intervention group (Gray et al., which was lower than the control
200258) group (Gray et al., 200258)
Mean difference in heart rate change at Mean difference in heart rate change at
the moment of injection was higher in the moment of injection compared
the control group compared with the with baseline was lower in the
breastfeeding, swaddling, and breastfeeding, swaddling, and
combined groups. There was no combined groups compared with
difference in heart rate two minutes control group but not different
after vaccination (Hashemi et al., between the three intervention groups.
201660) There was no difference in heart rate
two minutes after vaccination
(Hashemi et al., 201660)
Yasmeen et al.
reserved.
There was no difference between control There was no difference between control
and intervention groups (Johnston and intervention groups (Johnston
et al., 200363) et al., 200363)
Infants returned to baseline heart rate in Infants returned to baseline heart rate in
193 seconds, which was longer than the 123 seconds, which was shorter than
intervention group (Johnston et al., the control group (Johnston et al.,
200864) 200864)
No difference in mean values between No difference in mean values between
KMC and enhanced KMC at all time KMC and enhanced KMC at all time
points (Johnston et al., 200965) points (Johnston et al., 200965)
No difference in change in heart rate No difference in change in heart rate
between intervention and control between intervention and control
groups during and three minutes after groups during and three minutes after
the injection (Khodam et al., 200269) the injection (Khodam et al. 200269)
There was no difference in heart rate There was no difference in heart rate
groups during and five minutes after groups during and five minutes after
the injection (Kostandy et al., 201371) the injection (Kostandy et al., 201371)
During heel stick, mean rise in heart rate During heel stick, mean rise in heart rate
was higher in the control group than was lower in the intervention group

the intervention group (P ¼ 0.042) than the control group (P ¼ 0.042)
(Ludington-Hoe et al., 200574) (Ludington-Hoe et al., 200574)
groups (P ¼ 0.28) (Nanavati et al., groups (P ¼ 0.28) (Nanavati et al.,
201379) 201379)
Mean pulse rate change was 1.43 (SD Mean pulse rate change was 0.85 (SD
0.88) in the control group, which was 0.65) in the intervention group, which
higher than the intervention group was lower than the control group
(Nimbalkar et al., 201380) (Nimbalkar et al., 201380)
Heart rate was higher in the control Heart rate was lower during five minutes
group during five minutes after heel after heel prick in the KMC and
prick compared with KMC and combined (KMC þ breastfeeding)
combined (KMC þ breastfeeding) groups, but scores were not different
groups (Okan et al., 201082) between the two pain intervention
groups (Okan et al., 201082)

No control, comparison between three Infants who were breastfed had less
pain interventions (Phillips et al., change in mean heart rate compared
200584) with infants who were held in their
mothers’ arms with a pacifier (Phillips

et al., 200584)
between groups during and three between groups during and three
minutes after intramuscular injection minutes after intramuscular injection
(Saeidi et al., 200785) (Saeidi et al., 200785)
Two minutes after blood sampling, mean Two minutes after blood sampling, mean
heart rate was 152.2 (SD 23.47) beats/ heart rate was 138.9 (SD 11.25) beats/
minute in the control group, which was minute in the intervention group,
higher than the intervention group which was lower than the control
(Seo et al., 201689) group (Seo et al., 201689)
No control, comparison between three There was no difference in heart rate
pain interventions (Soltani et al., between the four pain intervention
201895) groups (Soltani et al., 201895)
Outcome: Oxygen saturation level (patient)
Observational Mean oxygen saturation levels at 15 and Mean oxygen saturation levels at 15 and Low
30 minutes after heel prick were 95.42 30 minutes after heel prick were 95.90

(SD 3.41) and 94.72 (SD 3.42), which (SD 3.12) and 95.30 (SD 3.29), which
was not different from the intervention was not different from the control
group (P ¼ 1.92) (Chidambaram et al., group (P ¼ 1.92) (Chidambaram et al.,
201449) 201449)
Oxygen saturation levels were lower in Oxygen saturation levels were higher in
the control group compared with KMC the KMC and swaddling groups
and swaddling groups (Dezhdar et al., compared with control group
201650) (Dezhdar et al., 201650)
Transcutaneous oxygen saturation levels Transcutaneous oxygen saturation levels
reserved.
were higher in the control group were lower in the KMC group
compared with KMC group 30 seconds compared with control group
after heel lance (Freire et al., 200854) 30 seconds after heel lance (Freire
et al., 200854)
Mean change in blood oxygen saturation Mean change in blood oxygen saturation
at the moment of injection and two at the moment of injection and two
minutes after vaccination was not minutes after vaccination was not
different between the control and different between the control and
intervention groups (Hashemi et al., intervention groups (Hashemi et al.,
201660) 201660)
and intervention groups (Johnston and intervention groups (Johnston
et al., 200363) et al., 200363)
No difference in oxygen saturation levels No difference in oxygen saturation levels
between intervention and control between intervention and control
groups during and three minutes after groups during and three minutes after
the injection (Khodam et al., 200269) the injection (Khodam et al., 200269)
There was no difference in oxygen There was no difference in oxygen
saturation levels between control and saturation levels between control and
intervention groups (P ¼ 0.25) intervention groups (P ¼ 0.25)
(Nanavati et al., 201379) (Nanavati et al., 201379)
Mean change in oxygen saturation level Mean change in oxygen saturation level
was 1.17 (SD 1.09) in the control was 0.68 (SD 0.86) in the intervention
group, which was higher than the group, which was lower than the
intervention group (Nimbalkar et al., control group (Nimbalkar et al.,
201380) 201380)
Oxygen saturation levels in the control Oxygen saturation levels were lower
1046.e41
group during five minutes after heel during five minutes after heel prick in
prick were higher compared with KMC the KMC and combined
and combined (KMC þ breastfeeding) (KMC þ breastfeeding) groups, but
(Continued)
Appendix VIII
1046.e42
Continued
82
groups (Okan et al., 2010 ) scores were not different between the
two pain intervention groups (Okan
et al., 201082)
No control, comparison between three There was no difference in oxygen
pain interventions (Phillips et al., saturation levels between groups
200584) (Phillips et al., 200584)
saturation levels between groups saturation levels between groups
during and three minutes after during and three minutes after
intramuscular injection (Saeidi et al., intramuscular injection (Saeidi et al.,
200785) 200785)
saturation levels between group during saturation levels between group during
and three minutes after vaccination and three minutes after vaccination
(Saeidi et al., 201186) (Saeidi et al., 201186)
Two minutes after blood sampling, there Two minutes after blood sampling, there
was no difference in oxygen saturation was no difference in oxygen saturation
levels between groups (Seo et al., levels between groups (Seo et al.,
201689) 201689)
No control, comparison between three There was no difference in oxygen
pain interventions (Soltani et al., saturation levels between the four pain
201895) intervention groups (Soltani et al.,
201895)
Yasmeen et al.
reserved.
Outcome: Anxiety (caregiver)

STAI Mean score of the control group was Mean scores were 41.4 and 40.7 in the Low
45.2, which was higher than the parental presence and parental
parental presence (41.4) and parental intervention groups, respectively.
intervention (40.7) groups (Bauchner Scores were lower than the control
et al., 199641) group (P ¼ 0.025) (Bauchner et al.,
199641)
Outcome: Satisfaction (caregiver)
Structured questionnaire Parents in the control group were more Parents in the parental intervention Low
anxious (mean score 45.2) than the group (mean score 40.7) and parental
parental presence and parental presence group (mean score 41.4)
intervention groups (Bauchner et al., were less anxious than parents in the
199641) control group (Bauchner et al.,
199641)
Outcome: Depression (caregiver)
CES-D There was no difference in scores There was no difference in scores Low
Outcome: Self-efficacy (caregiver)
Parent’s Self-Efficacy Scale There was no difference in scores There was no difference in scores Low

Outcome: Stress (caregiver)
PTSD Symptom Scale There was no difference in scores There was no difference in scores Low
Outcome: Anxiety (provider)
STAI Mean score was 32.5 in the control Mean scores were 34.0 and 33.6 in the Low
group, which was not different from parental intervention and parental
the parental presence and parental presence groups, respectively. This was
intervention groups (Bauchner et al., not different from the control group
199641) (Bauchner et al., 199641)
Outcome: Hospital length of stay (health system)
Hospital length of stay was 16.1 (SD 13.4) Hospital length of stay was 21.4 (SD 13.4) Moderate
days in the control group. No between- days in the intervention group. No
group differences were reported between-group differences Were
(Akcan et al., 200937) reported (Akcan et al., 200937)
and intervention groups (Mehling and intervention groups (Mehling

et al., 201275) et al., 201275)
Outcome: Health system utilization (health system)
Preintervention values not reported Postintervention, 83% (n ¼ 20 of 24) of Low
(Hudgens, 197959) patients and families were using the
health care system appropriately
(Hudgens, 197959)
Caregiver-mediated pain interventions at inform-activate level in hospitalized patients compared with control intervention
Intervention: inform-activate caregiver-mediated interventions on pain (n ¼ 5)
Comparison: control, i.e. usual care, other intervention, no intervention
BPI (short form) About 2% of the control group had a About 37% of the intervention group Low
reduction in pain, which was lower had a reduction in pain. After
than the intervention group adjusting for preintervention pain,

88
(Stephenson et al., 2007 ) scores were lower in the intervention
group compared with control group
(Stephenson et al., 200788)
FLACC Scale Children in the preintervention group Children in the preintervention group
had more pain (P ¼ 0.001) than had more pain (P ¼ 0.001) than
children in the postintervention group children in the postintervention group
62
(Jenkins et al., 2019 ) (Jenkins et al., 201962)
VAS Mean pain scores during the first three Mean pain scores during the first three
days after surgery were lower in the days after surgery were lower in the
reserved.
intervention group compared with the intervention group compared with the
control group. Day 1: 6.5 (SD ¼ 1.30); control group. Day 1: 5.22 (SD ¼ 1.48);
Day 2: 4.81 (SD ¼ 1.32); and Day 3: Day 2: 2.92 (SD ¼ 1.20); and Day 3:
3.39 (SD ¼ 1.53) (Rahmani et al., 1.76 (SD ¼ .67) (Rahmani et al.,
93
2019 ) 201993)
Structured questionnaire Mean scores of mother-reported infant Mean scores of mother-reported infant
pain during vaccinations in the pain pain during vaccinations in the pain
pamphlet group (5.7; SD ¼ 2.2) and pamphlet group (5.7; SD ¼ 2.2) and
the combined pain pamphlet and pain the combined pain pamphlet and pain
video group (5.6; SD ¼ 2.2) were lower video group (5.6; SD ¼ 2.2) were lower
than mean score of mothers in the than mean score of mothers in the
control group (6.0; SD ¼ 2.1) (Taddio control group (6.0; SD ¼ 2.1) (Taddio
96
et al., 2018 ) et al., 201896)
Child’s Pain Diary Form There were no differences in the highest There were no differences in the highest
pain score in 24 hours after the surgery pain score in 24 hours after the surgery
between the three groups (P ¼ 0.299) between the three groups (P ¼ 0.299)
or between 24 hours and two weeks or between 24 hours and two weeks
after the surgery among the three after the surgery among the three
groups (P ¼ 0.945) (Zhu et al., 201897) groups (P ¼ 0.945) (Zhu et al., 201897)
Outcome: Behavior change (caregiver)
CAMPIS-PACU Parents in the intervention group Low
increased their rate of desired
behaviors by 124% (P ¼ 0.033; Cohen’s
d ¼ 0.61). Parents in the intervention
group decreased their rate of
nondesired behaviors by 26%, but it
was not statistically significant
(P ¼ 0.494; Cohen’s d ¼ 0.19) (Jenkins
1046.e43
(Continued)
Appendix VIII
1046.e44
Continued
62
et al., 2019 )
Outcome: Attitudes and beliefs about pain and pain management (caregiver)
Structured questionnaire Mothers in the two pain education Mothers in the two pain education High
groups had more positive perceptions groups had more positive perceptions
about the importance of managing about the importance of managing
vaccination pain than mothers in the vaccination pain than mothers in the
control group (Taddio et al., 201896) control group (Taddio et al., 201896)
PMKA questionnaire There were no statistically significant There were no statistically significant
differences in parents’ general differences in parents’ general
attitudes toward pain management attitudes toward pain management
among the three groups (Zhu et al., among the three groups (Zhu et al.,
201897) 201897)
Outcome: Knowledge about pain management (caregiver)
Structured questionnaire Mothers in the two pain education Mothers in the two pain education High
groups reported higher scores on the groups reported higher scores on the
knowledge test than mothers in the knowledge test than mothers in the
control group (Taddio et al., 201896) control group (Taddio et al., 201896)
PMKA questionnaire Between the control and Intervention 1 Between the control and Intervention 1
groups, parents in Intervention 1 groups, parents in Intervention 1
group showed greater knowledge on group showed greater knowledge on
pain management (P ¼ 0.046) (Zhu pain management (P ¼ 0.046) (Zhu
et al., 201897) et al., 201897)
Yasmeen et al.
Outcome: Satisfaction with pain management (caregiver)
reserved.
Six-point ordinal descriptive scale There were no statistically significant There were no statistically significant Low
differences in parents’ satisfaction with differences in parents’ satisfaction with
pain management between the three pain management between the three
groups (P ¼ 0.069) (Zhu et al., 201897) groups (P ¼ 0.069) (Zhu et al., 201897)
Outcome: Behavior change provider)
CAMPIS-PACU Nurses statistically significantly increased Low
their rate of desired behaviors by 231%
(z ¼ 3.233; P ¼ 0.001; Somer’s D ¼ 1)
and decreased their rate of nondesired
behaviors by 62% (z ¼ 2.888;
P ¼ 0.004; Somer’s D ¼ 0.88; 95% CI
[1.74, 0.03]) (Jenkins et al.,
201962)
Caregiver-mediated pain interventions using activate-collaborate engagement strategy in hospitalized patients compared with control intervention
Intervention: activate-collaborate caregiver-mediated interventions on pain (n ¼ 3)
Modified Behavioral Pain Scale Mean scores were 5.68 (SD 1.20) and 5.67 Mean scores were 5.40 (SD 1.16) and 5.13 Low
(SD 1.01) at four-month and 12-month (SD 1.61) at four-month and 12-month

vaccination periods, respectively. vaccination periods. Scores were not
Scores were not different from the different from the control group
intervention group (Miles et al., (Miles et al., 200676)
76
2006 )
VAS In the control group, patient pain had In the intervention group, patient pain
increased on the 15th day of the was reduced on the 15th day of
intervention compared from the first receiving reflexology sessions from the
day by 0.70 points (SD ¼ 1.08) first day by 1.66 points (SD ¼ 2.84)
94
(Samancioglu & Bakir, 2019 ) (Samancioglu & Bakir, 201994)
Outcome: Anxiety (patient)
VASdanxiety In the control group, anxiety scores were In the intervention group, anxiety had Low
not statistically different between Day 1 reduced by 1.33 points (SD ¼ 2.70) on
and Day 15 of the intervention the 15th day of the intervention from
(Samancioglu & Bakir, 201994) the first day (Samancioglu & Bakir,
201994)
Outcome: Fatigue (patient)
VASdfatigue In the control group, fatigue had In the intervention group, fatigue had Low
reduced by 1.13 points (SD ¼ 2.76) on reduced by 1.20 points (SD ¼ 2.15) on
the 15th day of the intervention from the 15th day of the intervention from
the first day (Samancioglu & Bakir, the first day (Samancioglu & Bakir,
201994) 201994)
Structured questionnaire Uncertain if caregivers in the control Postintervention, caregivers were highly Low
group were surveyed (Livingston et al., satisfied (Livingston et al., 200973)
200973)
Outcome: Depression (caregiver)
BDI-II On Day 7, mean score 6.0 (SD 4.3) On Day 7, mean score was 9.2 (SD 4.8) Low
(Livingston et al., 200973) (Livingston et al., 200973)
Edinburgh Postnatal Depression At four-month vaccination period, mean At four-month vaccination period, mean
Scale score was 6.00 (SD 5.09), which was not score was 6.57 (SD 4.71), which was not
different from the intervention group different from the control group
(Miles et al., 200676) (Miles et al., 200676)

STAI Scores were 35.26 (SD 12.09) and 30.79 Scores were 34.09 (SD 10.78) and 31.49 Low
(SD 11.94) at infant discharge and (SD 10.52) at infant discharge and
four-month vaccination period, four-month vaccination period,
respectively. Scores were not different respectively. Scores were not different
from the intervention group (Miles from the control group (Miles et al.,
et al., 200676) 200676)
Outcome: Burden (caregiver)
Zarit Caregiver Burden Interview In the control group, the burden score In the intervention group, burden had Low
on the 15th day of the intervention was reduced by 1.96 points (SD ¼ 4.52) on
reserved.
not statistically different from the first the 15th day of the intervention from
day (mean difference ¼ 2.06; the first day (Samancioglu & Bakir,
SD ¼ 7.86) (Samancioglu & Bakir, 201994)
201994)
Outcome: Satisfaction (provider)
Stuctured questionnaire Uncertain if providers in the control CIMIs and nurses who participated Low
group were surveyed (Livingston et al., expressed high levels of satisfaction
200973) with the massage program (Livingston
et al., 200973)
Outcome: Hospital length of stay (health system)
Mean length of stay was 35.4 (SD 39.1) Mean length of stay was 56.8 (32.2) days, Low
days, which was not different from the which was not different from the
intervention group (Livingston et al., control group (Livingston et al.,
73
2009 ) 200973)
Caregiver-mediated pain interventions using inform-activate-collaborate strategy in hospitalized patients compared with control intervention
Intervention: inform-activate-collaborate caregiver-mediated interventions on pain (n ¼ 6)
HOOSdpain dimension At three months, scores decreased within At three months, scores decreased within Low
the control group, but there was no the intervention group, but there was
difference between control and no difference between control and
intervention groups (Berthelsen & intervention groups (Berthelsen &
42
Kristensson, 2017 ) Kristensson, 201742)
Oucher Within control group, pain rated by Within intervention group, pain rated by
parent decreased significantly during parent decreased significantly during
the three days. There was no difference the three days. There was no difference
in pain rated by the child or parent in pain rated by the child or parent
1046.e45
(Continued)
Appendix VIII
1046.e46
Continued
61 61
groups (Huth et al., 2003 ) groups (Huth et al., 2003 )
Chart review Mean scores per shift during the first six Mean scores per shift during the first six
postoperative days were 2.84, which postoperative days were 2.12, which
was higher than that in the was lower than the control group
intervention group (Sharek et al., (Sharek et al., 200690)
200690)
Outcome: Depression (patient)
GDS-15 At three months, there was no difference At three months, there was no difference Low
in scores between control and in scores between control and
Kristensson, 201742) Kristensson, 201742)
CASI At three months, there was no difference At three months, there was no difference Low
GAD-7 At three months, there was no difference At three months, there was no difference Low
State Anxiety Assessment Form Caregivers in the intervention group Caregivers in the intervention group
Yasmeen et al.
(adapted from STAI form) reported reduced mean state anxiety reported reduced mean state anxiety
scores at post-test (34.10; SD ¼ 4.48) scores at post-test (34.10; SD ¼ 4.48)
reserved.
compared with the control group compared with the control group
(48.55; SD ¼ 2.89). There were no (48.55; SD ¼ 2.89). There were no
statistically significant difference in statistically significant difference in
mean pretest scores between the two mean pretest scores between the two
groups (Pattangtanang et al., 201883) groups (Pattangtanang et al., 201883)
Outcome: Caregiving competency (caregiver)
SICS At three months, mean score was 90.99 At three months, mean score was 91.25 Moderate
(SD 6.71), which was not different (SD 9.49), which was not different
from the intervention group (Franck from the control group (Franck et al.,
et al., 201152) 201152)
Outcome: Attitude about pain (caregiver)
MAQ Scores were not different between Within the intervention group, parents’ Low
control and intervention groups (Huth attitude scores increased compared
et al., 200361) with baseline, but scores were not
different from the control group
(Huth et al., 200361)
Outcome: Knowledge about pain (caregiver)
Structured questionnaire Control parents were interested in Intervention parents wanted to know Low
knowing how infants felt pain and if it about the long-term effects of infant

was different from adults, which pain (such as being more sensitive or
medical procedures caused pain, tolerant to pain) and how they can
recognition of pain, available options treat pain at home postdischarge
for pain prevention, and how they can (Franck et al., 201253)
be involved in comforting their infants
(Franck et al., 201253)
Assessment of understanding form Caregivers in the intervention group Caregivers in the intervention group
reported increased understanding of reported increased understanding of
taking care of their children taking care of their children
postsurgery at post-test (84.85; postsurgery at post-test (84.85;
SD ¼ 2.11) compared with the control SD ¼ 2.11) compared with the control
group (79.85; SD ¼ 1.79). There were group (79.85; SD ¼ 1.79). There were

no statistically significant differences in no statistically significant differences in
Caregivers in the intervention group Caregivers in the intervention group
reported increased understanding of reported increased understanding of

pain assessment and management for pain assessment and management for
their children at post-test (83.55; their children at post-test (83.55;
SD ¼ 1.82) compared with the control SD ¼ 1.82) compared with the control
group (69.60; SD ¼ 2.30). There was group (69.60; SD ¼ 2.30). There was
no statistically significant difference in no statistically significant difference in
GRADE ¼ Grading of Recommendations Assessment Development and Evaluation; EMPOWER ¼ Effective Management of Pain: Overcoming Worries to Enable Relief; FPQ ¼ Fear of Pain Questionnaire; PIPP ¼ Pre-
mature Infant Pain Profile; KMC ¼ kangaroo mother care; EKMC ¼ enhanced kangaroo mother care; KC ¼ kangaroo care; NIPS ¼ Neonatal Infant Pain Scale; NFCS ¼ Neonatal Facial Coding System; DAN ¼ Douleur
Aigue Nouveau-ne; STAI ¼ State-Trait Anxiety Inventory; CES-D ¼ Center for Epidemiologic Studies Depression Scale; PTSD ¼ posttraumatic stress disorder; BPI ¼ Brief Pain Inventory; FLACC ¼ Faces Legs Activity Cry
and Consolability Scale; VAS ¼ Visual Analogue Scale; CAMPIS-PACU ¼ Child-Adult Medical Procedure Interaction Scale-postanesthesia care unit; PMKA ¼ Pain Management Knowledge and Attitudes; BDI-II ¼ Beck
Depression Inventory-II; CIMIs ¼ certified infant massage instructors; HOOS ¼ Hip Disability and Osteoarthritis Outcome Score; GDS-15 ¼ Geriatric Depression Scale 15; CASI ¼ Carer’s Assessment of Satisfaction Index;
GAD-7 ¼ Generalized Anxiety Disorder 7 Scale; SICS ¼ Self-efficacy in Infant Care Scale; MAQ ¼ Medication Attitude Questionnaire.

reserved.
1046.e47

The Effect of CaregiverFacilitated Pain Management Interventions in Hospitalized Patients On Patient Caregiver Provider and Health System Outcomes A Systematic Review

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1034 Journal of Pain and Symptom Management Vol. 60 No.

The Effect of Caregiver-Facilitated Pain Management

Background (OVID), PsycINFO (ProQUEST), CINAHL (EBSCO),

Records identified through Additional records identified

Records after duplicates removed

Records screened Records excluded

Full-text articles assessed Full-text articles excluded (n = 183)

(n = 244) Intervention not related to pain

Ineligible study design (e.g.,

Results breastfeeding (n ¼ 7 of 46; 15.2%)46,51,58,60,82,84,95

Vol. 60 No. 5 November 2020

Vol. 60 No. 5 November 2020

Caregiver-Mediated Pain Management in Hospitalized Patients

1c,76 1c,76 2c,73,d,76 1c,73,d 1c,73

Full-term neonates 18b,46,48,51,57,58,60,68,71,81,82,84e87,89,95,96 17b,46,48,51,57,58,60,68,71,81,82,84e87,89,95,96 1b,96 d

Vol. 60 No. 5 November 2020

Health system outcomes (n ¼ 4) included length of Acceptability and Feasibility

48. ("double blind" or double-blind).mp.

Inform Condition and treatment education

Caregiver-Mediated Pain Management in Hospitalized Patients

effects. In the opioid group, infants were

immediately before heel stick and

Vol. 60 No. 5 November 2020

present during procedures (venipuncture, satisfaction with care between all

intravenous cannulation, or uretheral three groups

Caregiver-Mediated Pain Management in Hospitalized Patients

actions together with the patient and

lavender (54%) and frankincense

Vol. 60 No. 5 November 2020

Vol. 60 No. 5 November 2020

starting two minutes before venipuncture held in mother’s arms, but no

Caregiver-Mediated Pain Management in Hospitalized Patients

the infant during heel prick

Swaddling: The neonate with a clean diaper

Vol. 60 No. 5 November 2020

containing evidence-based information

about pain and comforting infants in the

Caregiver-Mediated Pain Management in Hospitalized Patients

booklet, parents received a booklet interested in knowing how infants

test. Infant was prepared by warming the

Vol. 60 No. 5 November 2020

during heel prick was less in the

intervention group compared with

Caregiver-Mediated Pain Management in Hospitalized Patients

infant for a two-minute baseline period,

care system appropriately

Vol. 60 No. 5 November 2020

Vol. 60 No. 5 November 2020

Practical management activities control group (P ¼ 0.001)

A literature search identified target parent Caregiver

Caregiver-Mediated Pain Management in Hospitalized Patients

breasts for maximum skin contact, at an Infants returned to baseline heart

heel lance and continued during the

Vol. 60 No. 5 November 2020

Caregiver-Mediated Pain Management in Hospitalized Patients

control group (95%). Infants in the

duration of the procedure ranged from 30

Vol. 60 No. 5 November 2020

seven days compared with baseline.

next sessions, caregivers were encouraged Caregivers in the intervention

Caregiver-Mediated Pain Management in Hospitalized Patients

Intervention: While the child was in the postintervention depression and

coordinator made monthly follow-up anxiety (discharge, four-month, 12-