JBUR 5437 No.

of Pages 12

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Available online at www.sciencedirect.com

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Review

Efficacy of non-pharmacological interventions for

procedural pain relief in adults undergoing burn
wound care: A systematic review and meta-analysis
of randomized controlled trials

Michael Scheffler a , Susan Koranyi b, Winfried Meissner c ,

Bernhard Strauß a, Jenny Rosendahl a, *
a
Jena University Hospital, Institute of Psychosocial Medicine and Psychotherapy, Jena, Germany
b
University Hospital Leipzig, Department of Medical Psychology and Medical Sociology, Leipzig, Germany
c
Jena University Hospital, Department of Anesthesiology and Intensive Care Medicine, Jena, Germany

article info abstract

Article history: The aim of the present meta-analysis was to investigate the efficacy of non-pharmacological
Accepted 30 November 2017 interventions for procedural pain relief in adults undergoing burn wound care compared to
Available online xxx standard care alone or an attention control.
Through a comprehensive literature search in various electronic databases 21 eligible
randomized controlled trials (RCTs) were included, comprising a total of 660 patients.
Keywords:
Random effects meta-analyses revealed significant positive treatment effects on pain
Burn wound care
outcomes, Hedges’ g=0.58, 95% CI [0.33; 0.84]. Heterogeneity of study effects was substantial,
Non-pharmacological interventions
I2 =72%. Effects were significantly larger for comparisons against treatment as usual (TAU),
Systematic review
g=0.69, CI 95% [0.40; 0.98] than for comparisons against attention control groups, g=0.21
Meta-analysis
[ 0.11; 0.54], p<0.001. Distraction interventions, particularly those using virtual reality, and
hypnosis revealed the largest effects on pain relief. Non-pharmacological interventions
further resulted in a significant small, homogeneous effect on anxiety reduction, g=0.36
[0.20; 0.52].
In summary, benefits of non-pharmacological interventions on procedural pain relief and
reduction of mental distress were demonstrated. Results have been proven to be free of
publication bias. However, further high quality trials are needed to strengthen the promising
evidence.
© 2017 Elsevier Ltd and ISBI. All rights reserved.

Contents
1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00
2. Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00

* Corresponding author at: Jena University Hospital, Friedrich Schiller University, Institute of Psychosocial Medicine and Psychotherapy,
Germany.
E-mail address: jenny.rosendahl@med.uni-jena.de (J. Rosendahl).
https://doi.org/10.1016/j.burns.2017.11.019
0305-4179/© 2017 Elsevier Ltd and ISBI. All rights reserved.

Please cite this article in press as: M. Scheffler, et al., Efficacy of non-pharmacological interventions for procedural pain relief in adults
undergoing burn wound care: A systematic review and meta-analysis of randomized controlled trials, Burns (2017), https://doi.org/
10.1016/j.burns.2017.11.019
JBUR 5437 No. of Pages 12

2 burns xxx (2017) xxx –xxx

2.1. Protocol and registration . . . . . . . . . . . . . . . . . . . . . . . . . . .... .... .... ... .... .... .... .... .... .... ... .... 00
2.2. Identification and selection of studies . . . . . . . . . . . . . . . .... .... .... ... .... .... .... .... .... .... ... .... 00
2.3. Data extraction and management . . . . . . . . . . . . . . . . . . .... .... .... ... .... .... .... .... .... .... ... .... 00
2.4. Assessing the risk of bias in included studies . . . . . . . . . .... .... .... ... .... .... .... .... .... .... ... .... 00
2.5. Summary measures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... .... .... ... .... .... .... .... .... .... ... .... 00
2.6. Data synthesis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... .... .... ... .... .... .... .... .... .... ... .... 00
2.7. Risk of bias across studies . . . . . . . . . . . . . . . . . . . . . . . . . .... .... .... ... .... .... .... .... .... .... ... .... 00
2.8. Additional analyses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... .... .... ... .... .... .... .... .... .... ... .... 00
3. Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... .... .... ... .... .... .... .... .... .... ... .... 00
3.1. Study selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... .... .... ... .... .... .... .... .... .... ... .... 00
3.2. Study characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... .... .... ... .... .... .... .... .... .... ... .... 00
3.3. Risk of bias within studies . . . . . . . . . . . . . . . . . . . . . . . . . .... .... .... ... .... .... .... .... .... .... ... .... 00
3.4. Results of individual studies and synthesis of results . . .... .... .... ... .... .... .... .... .... .... ... .... 00
3.5. Risk of bias across studies . . . . . . . . . . . . . . . . . . . . . . . . . .... .... .... ... .... .... .... .... .... .... ... .... 00
3.6. Additional analyses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... .... .... ... .... .... .... .... .... .... ... .... 00
4. Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... .... .... ... .... .... .... .... .... .... ... .... 00
4.1. Summary of the evidence . . . . . . . . . . . . . . . . . . . . . . . . . .... .... .... ... .... .... .... .... .... .... ... .... 00
4.2. Agreements with other reviews . . . . . . . . . . . . . . . . . . . . .... .... .... ... .... .... .... .... .... .... ... .... 00
4.3. Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... .... .... ... .... .... .... .... .... .... ... .... 00
4.4. Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... .... .... ... .... .... .... .... .... .... ... .... 00
Conflict of interest statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... .... .... ... .... .... .... .... .... .... ... .... 00
Contributions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... .... .... ... .... .... .... .... .... .... ... .... 00
Acknowledgement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... .... .... ... .... .... .... .... .... .... ... .... 00
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... .... .... ... .... .... .... .... .... .... ... .... 00

usually conducted as an adjunct to standard care within

1. Introduction
Patients with severe burns not only suffer from physical and
psychological distress from the injury itself, they also have to
cope with daily painful experiences from therapeutic proce-
dures such as physical therapy or wound care, i.e., removal of
dressings, washing, debridement, and application of new
dressings. Burn pain has been proven as being maximal during
therapeutic procedures and wound debridement might be
more painful than the burn injury itself [1].
Pharmacological approaches such as opioid analgesics
are recommended as first-line treatment for procedural
pain [2]. However, some patients have little or no response
to opioids. Even patients who respond to pharmacological
pain therapy still experience considerable pain, often
described as “excrutiating” [3]. Furthermore, opioid analge-
sics often lead to unwanted side effects (e.g., nausea,
constipation, sedation, respiratory depression, tolerance
and the risk of physical and psychological dependence)
limiting the use of analgesics, particularly when adminis-
tered over prolonged periods [4]. Hence, additional non-
pharmacological interventions are indicated to improve
pain management.
Pain experience is thought to involve different components
that are separately assessable and sometimes might be
differentially affected [5–8]: a sensory component (e.g., pain
intensity), an affective component (e.g., pain unpleasantness),
and a cognitive component of pain (e.g., amount of time spent
thinking about pain).
Non-pharmacological interventions are used to address
these different components of burn pain as well as mental
distress associated with painful procedures. They are
the time of hospitalization by physicians, psychologists, or
nurses including, e.g., personal communication, printed
information (leaflets), audio or video recordings, or use of
virtual reality (VR).
The following non-pharmacological interventions are
common in the context of burn wound care [9–12]. Distraction
aims at diverting attention towards a non-painful stimulus to
lessen the intensity of perceived pain by providing additional
stimuli to the environment such as music or watching films. In
recent years, virtual reality (VR) has established as a new form
of distraction, giving the patient the illusion of immersion into
a three-dimensional computer-generated environment as if it
were a place in which they are physically present [13]. Sensory
focusing interventions (i.e., attention towards sensations) may
reduce distress by distracting the individual from interpreting
the meaning of the sensations, by providing valuable self-
regulatory information about the sensations, and by increas-
ing perceptions of control. Moreover, sensory focusing appears
to positively affect memories of pain [14]. Relaxation techniques
are used to reduce overall arousal by down-regulating
sympathetic tone. Commonly applied techniques are deep
breathing or progressive muscle relaxation [12]. Hypnosis
alters the state of consciousness, allowing for a more
suggestible state; thus, changing the perception of pain might
be eased [12]. It has been discussed that hypnosis works
mainly through two mechanisms — reducing distress and
targeting patient expectancies with suggestions for positive
outcomes [15]. One of the most common hypnosis protocols
used in burn care is Barber’s Rapid Induction Analgesia (RIA), a
hypnotherapeutic technique for developing analgesia and
muscular relaxation within a short period of time [16]. In
many studies these types of interventions may overlap, e.g.

Please cite this article in press as: M. Scheffler, et al., Efficacy of non-pharmacological interventions for procedural pain relief in adults
undergoing burn wound care: A systematic review and meta-analysis of randomized controlled trials, Burns (2017), https://doi.org/
10.1016/j.burns.2017.11.019
JBUR 5437 No. of Pages 12
burns xxx (2017) xxx –xxx
music-based interventions can affect patients by both distrac-
tion and relaxation.
To date, there are only a few systematic reviews on the
efficacy of non-pharmacological interventions for procedural
pain relief in adult burn patients. For example, de Jong et al.
[9,17] systematically reviewed non-pharmacological interven-
tions for procedural pain relief in burn patients. Additionally,
another review [18] focused particularly at the use of VR in
burn injury patients. However, results of these three reviews
remain descriptive in nature since no meta-analytic summary
of the effects was provided.
There is only one review also comprising meta-analytic
estimates including 17 studies [19], however, inclusion was
limited to a single type of intervention, i.e., music
interventions.
Hence, the present review aims at providing a current
comprehensive overview on the efficacy of non-pharmaco-
logical interventions for procedural pain relief in adults
undergoing burn wound care by including randomized trials
only. In addition to pain, we will focus on the effects regarding
the reduction of mental distress in burn patients.
2. Methods
2.1. Protocol and registration
The systematic review and meta-analysis were performed in
accordance with the PRISMA Statement [20]. Objectives,
inclusion criteria, and methods have been pre-specified in a
registered review protocol (International prospective register
of systematic reviews: CRD42016037227).
2.2. Identification and selection of studies
Eligible studies were randomized controlled trials that
investigated non-pharmacological interventions to adult
patients (mean age of the study sample 21years) undergoing
burn wound care. We included both, parallel group and
crossover designs. If the intervention group received a
combination of non-pharmacological and another pharmaco-
logical intervention (beyond routine care), the study was
excluded. Eligible control groups were “treatment as usual”
(defined as the standard pain management and burn wound
care policy of the hospital) and “attention control” groups
(defined as providing same amount of time and attention to
the patients in addition to standard care). The following
outcomes measured within hospitalization via self- and/or
observer reports were considered: as primary outcomes pain,
mental distress; as secondary outcomes medication (e.g.,
analgesics and anesthetics) and wound healing (Supplemen-
tary Table S1 in the online version at DOI:10.1016/j.
burns.2017.11.019).
Electronic searches were carried out in the databases
MEDLINE, Web of Science, and PsycINFO (last search May,
2016) according to a search strategy that specified terms
referring to the patient population (e.g., burn), treatment (e.g.,
hypnosis), and study design (e.g., randomized controlled trial).
The search strategy was developed with consideration of
validated search strategies for retrieving randomized
Please cite this article in press as: M. Scheffler, et al., Efficacy of non-pharmacological interventions for procedural pain relief in adults
undergoing burn wound care: A systematic review and meta-analysis of randomized controlled trials, Burns (2017), https://doi.org/
10.1016/j.burns.2017.11.019
3
controlled trials [21]. The MEDLINE search strategy is shown
in Supplementary Table S2 in the online version at
DOI:10.1016/j.burns.2017.11.019. We adapted the strategy for
Web of Science and PsycINFO.
In order to identify further trials, lists of references of
relevant articles and previous reviews were also checked.
Additionally, we screened ProQuest Dissertations and
Theses Full Text Database to identify any unpublished
material. One author (MS) screened titles and abstracts of
database records and retrieved full texts for eligibility
assessment. Doubtful cases were discussed with a second
author (JR).
2.3. Data extraction and management
A pilot-tested data extraction form was used to collect the
following information from eligible trials: characteristics of
patients, intervention, control group, outcomes, bibliographic
information, and effect size related data.
Data were independently extracted by two raters (MS, JR).
Inter-rater disagreement was resolved through consensus. In
case of missing information, study authors were contacted. If
information on effect sizes was missing and could not be
retrieved, data had to be approximated using different
estimation methods (e.g., estimating statistics from graphs
without numerical data, setting an effect size to zero if non-
significant results were mentioned without reporting statisti-
cal parameters).
2.4. Assessing the risk of bias in included studies
Risk of bias in the included studies was assessed by common
markers of internal validity from the Cochrane Risk of Bias
Tool [22]. The risk of selection bias (sequence generation,
allocation sequence concealment) and the risk of reporting
bias (selective outcome reporting) were assessed at study
level; the risk of detection bias (blinding of outcome
assessors) as well as attrition bias (handling incomplete
outcome data) at outcome level, respectively. However,
performance bias, i.e., blinding of outcome assessors was
judged only for observer-reported outcomes, not for self-
reported.
Two independent, previously trained raters (MS, JR)
conducted the risk of bias assessment. Disagreements were
resolved through consensus.
2.5. Summary measures
We calculated bias-corrected standardized mean differences
(Hedges’ g) [23]. An effect size of 0.5 thus indicates that the
mean of the intervention group is half a standard deviation
larger than the mean of the control group. Positive effect sizes
indicate a superiority of the non-pharmacological interven-
tion, while negative effect sizes suggest a superiority of the
control treatment (e.g., standard care). The magnitude of
Hedges’ g was interpreted within the same ranges as Cohen’s
d, regarding 0.20, 0.50, and 0.80 as small, medium, and large
effect sizes, respectively [24]. For all dichotomous outcomes,
Log Odds Ratios were calculated and converted to Hedges’ g in
order to pool across different effect size formats [25]. If
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4 burns xxx (2017) xxx –xxx

available, intention-to-treat data were chosen instead of
completer data.
2.6. Data synthesis
All data analyses were performed using Comprehensive Meta-
Analysis (CMA; Version 3.0; Biostat Inc.). Outcome data were
meta-analyzed using a random-effects approach. We applied
the generic inverse variance method with heterogeneity
estimated using the DerSimonian–Laird method [26]. Statisti-
cal heterogeneity between trials was assessed with x2
heterogeneity tests (Cochran’s Q) and I2 statistic [27]. I2
describes the percentage of the variability in effect estimates
that is due to heterogeneity rather than chance, with values
from 0 to 40% indicating no important heterogeneity, 30%–60%
moderate, 50%–90% substantial, and 75%–100% considerable
heterogeneity, respectively [28].
We performed meta-analyses separately for the compari-
son against treatment as usual-control groups and against
attention control groups. For multiple, correlated comparisons
within a study, we adjusted data to overcome a unit-of-
analysis error [29]. In case of two intervention groups within a
study [14], we computed a combined effect defined as the
mean effect size in that study with a variance adjusted by a
correlation of 0.50 among the comparisons [25]. If multiple
outcomes were reported within one outcome domain (e.g. two
measures of anxiety), effect sizes were aggregated within
domains for each unit of analysis with correlations between
outcomes set at 0.50 [30].
2.7. Risk of bias across studies
In order to test for publication bias funnel plots were inspected
visually and the Egger test was run [31]. Additionally, Duval &
Tweedie’s trim and fill procedure was used to obtain an
adjusted estimate of the treatment effect after the publication
bias had been taken into account and to indicate how many
missing trials have been imputed to correct for publication bias
[32].
2.8. Additional analyses
We conducted sensitivity analyses in order to test the
robustness of findings, examining if meta-analytic results
change when excluding outliers (defined as effect sizes with
confidence intervals not over-lapping with the confidence
interval of the pooled standardized mean difference) [33] and
when excluding approximated effect sizes. Exploratory sub-
group analyses were run to explain statistical heterogeneity
[34].
3. Results
3.1. Study selection
We screened a total of 8.791 records and included N=21 RCTs in
the meta-analysis. Fig. 1 contains the flow chart of the study
selection process.

Fig. 1 – Flow chart of study selection process.

Please cite this article in press as: M. Scheffler, et al., Efficacy of non-pharmacological interventions for procedural pain relief in adults
undergoing burn wound care: A systematic review and meta-analysis of randomized controlled trials, Burns (2017), https://doi.org/
10.1016/j.burns.2017.11.019
JBUR 5437 No. of Pages 12
burns xxx (2017) xxx –xxx
3.2. Study characteristics
All of the included studies were published in English,
between 1981 and 2012. Among the primary studies, 17 were
from USA, 2 from Iran and one each from Australia and South
Africa, respectively. The 21 included RCTs provided
k=23 comparisons between an intervention and a control
group, incorporating a total of 660 patients (M =31.4, SD =25.4)
with n =404 in intervention groups (M =19.2, SD =13) and
n=402 patients in control groups (M =19.1, SD=12.9). Since
eight studies used a crossover (within-subject) design with
patients receiving standard care on one day and standard
care plus a non-pharmacological intervention on another
day of burn wound care, the total number of patients is
smaller than the sum of patients in intervention and control
groups. Weighted mean age of patients was 35.1 years
(SD=6.1). 76% of the patients were male (Table 1). Mean Total
Body Surface Area (TBSA) of the patients was 17.2% (SD =5.0).
Included studies most frequently reported on the efficacy of
distraction, mainly composed of virtual reality, music, or video
distraction. Seven studies examined distraction alone
[4,6,13,14,35–37], whereas four studies provided elements of
relaxation in combination with distraction [38–41]. Six further
studies evaluated hypnosis [42–47]; four studies examined the
efficacy of relaxation [48–51] and one study reported about a
cognitive intervention comprising sensory focusing [14].
Eighteen studies compared the effects of a non-pharmacolog-
ical intervention against treatment as usual. Attention control
was used as a comparison group in four primary studies, all of
them investigating the efficacy of hypnosis. Procedural pain
was reported in 18 studies, all of them yielding results for pain
intensity, six for pain unpleasantness and five for time spent
thinking about pain, respectively. Mental distress was mea-
sured in 12 trials, all providing results for anxiety. Effects on
medication were provided in one study. However, none of the
studies reported data on wound healing.
3.3. Risk of bias within studies
A lack of reporting impeded the evaluation of risk of bias
particularly for selection bias and reporting bias where more
than half of the studies did not allow for an informed decision.
Most of the studies did not ensure blinding of medical
personnel indicating a risk of performance bias. Moreover,
there was only little evidence of attrition bias; a majority of
studies had no attrition or reported on intention-to-treat
samples (Supplementary Table S3 in the online version at
DOI:10.1016/j.burns.2017.11.019).
3.4. Results of individual studies and synthesis of results
Across all studies, a medium effect on pain outcomes in favor
of non-pharmacological interventions appeared, Hedges’
g=0.58, 95% CI [0.33; 0.84], k=18, p<0.001. Heterogeneity of
study effects was substantial, I2 =72%, p(Q)<0.001. Effects
differed significantly with respect to the type of control group
(p=0.033). For comparisons against TAU the pooled effect was
g=0.69, CI 95% [0.40; 0.98], k=15, p<0.001 with substantial
heterogeneity (I2 =76%, p(Q)<0.001), while a small, non-
significant, homogeneous effect was shown when non-
Please cite this article in press as: M. Scheffler, et al., Efficacy of non-pharmacological interventions for procedural pain relief in adults
undergoing burn wound care: A systematic review and meta-analysis of randomized controlled trials, Burns (2017), https://doi.org/
10.1016/j.burns.2017.11.019
5
pharmacological interventions were compared to attention
control groups, g=0.21 [ 0.11; 0.54], k=4, p=0.195, I2 =0%, p(Q)
=0.561 (Fig. 2).
Regarding anxiety, non-pharmacological interventions
revealed a small, significant effect, g=0.36 [0.20; 0.52], k=12,
p<0.001, with no heterogeneity, I2 =0%, p(Q)=0.816 (Fig. 3).
Only one study [50] reported effects on medication, g=0.18
[ 0.24; 0.60], p=0.399.
3.5. Risk of bias across studies
A visual inspection of the funnel plots for the primary
outcomes pain and anxiety gave no indication of a publication
bias as trials are distributed symmetrically around the pooled
effect size (Supplementary Figs. S1 and S2 in the online version
at DOI:10.1016/j.burns.2017.11.019). Equally, Egger’s test of
funnel plot asymmetry did not indicate a publication bias
(p=0.122 for pain, p=0.299 for anxiety). Although Duval &
Tweedie’s trim and fill procedure resulted in two trimmed
studies for pain, the adjusted effect size did neither differ
considerably from the unadjusted values nor resulted in
deviating conclusions.
3.6. Additional analyses
Because significant differences in pain relief emerged between
comparisons against TAU and attention control, additional
analyses were run for including TAU comparisons only.
We differentiated effects on pain outcomes with respect to
sensory, affective, and cognitive components of pain, with
pooled effects being significant (p<0.001) for all outcomes;
effects on pain intensity were of medium size, whereas large
effects were found for pain unpleasantness and time spent
thinking about pain (Table 2). We further stratified analyses
according to different types of interventions, i.e., distraction,
hypnosis, relaxation, and the combination of relaxation and
distraction. We found significant large effects for distraction
and hypnosis, and significant medium effects for interven-
tions combining relaxation and distraction. In contrast,
relaxation did not result in significant pain relief. When
examining the subgroup of studies applying virtual reality
distraction, a significantly large effect emerged (Table 2). All
studies examining VR distraction, hypnosis, or a combination
of relaxation and distraction reported significant positive
effects.
Heterogeneity in the study sample was primarily due to one
outlying study [50]. When excluding this study, heterogeneity
dropped considerably to I2 =47%, though still remaining
significant (p=0.028, Supplementary Table S5 in the online
version at DOI:10.1016/j.burns.2017.11.019). In order to further
explain the substantial heterogeneity across study results in
pain relief, subgroup analyses were run. Significant differ-
ences were found only for sample size with studies including
less than 15 patients yielding larger effects than larger studies
(Supplementary Table S4 in the online version at DOI:10.1016/j.
burns.2017.11.019).
Sensitivity analyses approved the robustness of the
findings on the primary outcomes pain and anxiety since
results remained significant and similar in effect size when
excluding outliers or approximated effect sizes, respectively
 6

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10.1016/j.burns.2017.11.019
undergoing burn wound care: A systematic review and meta-analysis of randomized controlled trials, Burns (2017), https://doi.org/
Please cite this article in press as: M. Scheffler, et al., Efficacy of non-pharmacological interventions for procedural pain relief in adults

Table 1 – Characteristics of the included studies.

Authors Year Study design Treatment n Mean TBSA Intervention group Control group Outcomes
%
Wernick et al. [41] 1981 Parallel group Wound IG: 8 Stress inoculation treatment (including TAU Anxiety
debridement CG: 8 combination of education, physical
coping strategies, mental distraction,
focusing on environment, cognitive
reappraisal procedures and suggestions
to combine the techniques)
Miller et al. [39] 1992 Parallel group Wound IG: 9 IG: 19,9 Muralvision, a video program with TAU Pain (intensity)
debridement CG:8 CG: 23,5 music as a form of distraction during Anxiety
dressing changing.
Patterson [10] 1992 Parallel group Wound IG: 10 16 Hypnosis (RIA) before wound debride- 1) TAU Pain (intensity)
debridement CG: 10 ment with posthypnotic suggestions 2) AttCG (information +
and cues for comfort and relaxation relaxation instructions)
during their subsequent dressing

burns xxx (2017) xxx –xxx

changes. Cues were anchored by the
psychologist touching the subjects
shoulder or forehead. Patients should
remember the connected suggestions
later during the wound debridement
when they are touched in a similar
manner.
Everett et al. [42] 1993 Parallel group Wound IG: 8 13,5 Hypnosis (RIA) before wound debride- AttCG (information + Pain (intensity)
debridement CG: 8 ment with posthypnotic suggestions to relaxation instructions) Anxiety
get a numb feeling in the burned area
and a general feeling of comfort
throughout the procedure.
Patterson and Ptacek [45] 1997 Parallel group Wound 61 14 see Patterson [10] AttCG (information + Pain (intensity)
debridement relaxation instructions)
Field et al. [49] 1998 Parallel group Wound IG: 14 10 20 min massage sessions (Swedish TAU Pain (intensity, unpleasantness)
debridement CG: 14 massage stroking) once a day for one Anxiety
week just before wound debridement.
Hoffman et al. [6] 2000 Within subject Physical therapy 12 21 VR distraction during physical therapy TAU Pain (intensity,
with an environment-excluding VR unpleasantness, TSTAP)
helmet and a motion sensing system on Anxiety
head and hand. The environment was
“SpiderWorld”, a model of a tarantula
spider, which could be touched both
virtually and physically (furry object in
real world).
Wright and Drummond 2000 Parallel group Wound IG: 15 IG: 13,4 Hypnosis (RIA) before wound debride- TAU Pain (intensity,
[47] debridement ment with posthypnotic suggestions unpleasantness)
CG:15 CG: 11,7 and cues for comfort and relaxation Anxiety
during their subsequent dressing
changes. Visualization of descending a
20-step staircase was also used with the
 JBUR 5437 No. of Pages 12
Table 1 (continued)
10.1016/j.burns.2017.11.019
undergoing burn wound care: A systematic review and meta-analysis of randomized controlled trials, Burns (2017), https://doi.org/
Please cite this article in press as: M. Scheffler, et al., Efficacy of non-pharmacological interventions for procedural pain relief in adults

Authors Year Study design Treatment n Mean TBSA Intervention group Control group Outcomes
%
aim of getting an increasing feeling of
comfort and relaxation with every stair.
Fratianne et al. [38] 2001 Within subject Wound 25 10 Music therapy: consisting of MBI =music TAU Pain (intensity)
debridement assisted relaxation with imagery before Anxiety
and after treatment and MAE =distrac-
tion like active music listening and deep
breathing during the debridement
process.
Haythornthwaite et al. 2001 Parallel group Wound IG: 14 16,4 1) Sensory focusing: just before de- TAU Pain (intensity)
[14] debridement bridement patients were instructed by
tape (20 min) to focus their attention on
sensory experience during dressing
change.
CG:14 2) Music distraction: just before de-

burns xxx (2017) xxx –xxx

bridement patients were instructed by
tape (20min) in active listening techni-
ques, i.e., to focus their attention on
several aspects of music during dressing
change.
Hoffman et al. [4] 2001 Within subject Physical therapy 7 23,7 VR distraction during physical therapy TAU Pain (intensity,
with an environment-excluding VR unpleasantness, TSTAP)
helmet and a motion sensing system on
head and hand. The environment was
“SpiderWorld” (Hoffman et al. [6]) or
“SnowWorld” (Hoffman et al. [35])
Ferguson and Voll [48] 2004 Parallel group Physical therapy IG:5 IG: 14,4 Music relaxation: musical selection TAU Pain (intensity)
CG:6 CG: 26,8 from a choice of six cassette tapes with Anxiety
relaxing therapeutic music. Music was
played during physical therapy.
Harandi et al. [43] 2004 Parallel group Physical therapy IG: 22 IG: 27,1 Hypnosis (RIA) with Posthypnotic sug- TAU Pain (intensity)
CG: 22 CG: 30,2 gestions in first sessions. Second ses- Anxiety
sions included repetition of suggestions
and hypnotic cues just before physical
therapy.
Wiechman Askay et al. 2007 Parallel group Wound IG: 29 15 Hypnosis (RIA) prior to wound care with Att.CG (+ relaxing music) Pain (intensity,
[46] debridement CG: 28 posthypnotic suggestions and a tape of unpleasantness)
the induction for wound care together
with relaxing music during wound care.
Hoffman et al. [35] 2008 Within subject Wound 11 VR distraction during physical therapy TAU Pain (intensity,
debridement with an environment-excluding VR unpleasantness, TSTAP)
helmet with stereophonic sound. The
virtual environment was “SnowWorld”,
an ice landscape with figures like

(continued on next page)

7
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JBUR 5437 No. of Pages 12

Table 1 (continued)
10.1016/j.burns.2017.11.019
undergoing burn wound care: A systematic review and meta-analysis of randomized controlled trials, Burns (2017), https://doi.org/
Please cite this article in press as: M. Scheffler, et al., Efficacy of non-pharmacological interventions for procedural pain relief in adults

Authors Year Study design Treatment n Mean TBSA Intervention group Control group Outcomes
%
snowmen and penguins. Interaction
with environment by aiming and
shooting snowballs via Keyboard.
Konstantatos et al. [50] 2009 Parallel group Wound IG: 43 IG: 15,5 VR relaxation: VR device consisted of TAU (+ PCA) Pain (intensity)
debridement CG: 43 CG: 15,1 headset, DVD player and relaxation Anxiety
DVD. Additional PCA as in control group. Analgesic use
Carrougher et al. [13] 2009 Within subject Physical therapy 39 18,1 VR distraction during physical therapy TAU Pain (intensity,
with an environment-excluding VR unpleasantness, TSTAP)
helmet with stereophonic sound. The
virtual environment was “SnowWorld”
(Hoffman et al. [35]).
Morris et al. [37] 2010 Within subject Physical therapy 11 15 VR distraction with a head-mount dis- TAU Pain (intensity)
play and PC-joystick. Patients played a Anxiety
PC game during physical therapy.

burns xxx (2017) xxx –xxx

Tan et al. [40] 2010 Within subject Wound 29 11,5 see Fratianne [38] TAU Pain (intensity)
debridement Anxiety
Maani et al. [36] 2011 Within subject Wound 12 20,7 VR distraction during physical therapy TAU Pain (intensity,
debridement with an environment-excluding VR unpleasantness, TSTAP)
helmet with stereophonic sound. The
virtual environment was “SnowWorld”
(Hoffman et al. [35]).
Mohammadi Fakhar et al. 2013 Parallel group Wound IG: 50 20,3 Jaw relaxation was taught for three days TAU Anxiety
[51] debridement CG: 50 before treatments (20 min each day).
Then patients should use it while
wound debridement.

AttCG= attention control group, CG= control group, IG= intervention group, PCA =Patient-Controlled Analgesia, RIA =Rapid Induction Analgesia, TAU =treatment as usual, TSTAP =time spent thinking
about pain, VR =virtual reality.
JBUR 5437 No. of Pages 12

burns xxx (2017) xxx –xxx 9

Fig. 2 – Meta-analytic results for pain, specified for different control groups. Note: study effects for Haythornthwaite et al. [14]
were pooled for the subtotal and total mean effect.

Fig. 3 – Meta-analytic results for anxiety, specified for different control groups.

(Supplementary Table S5 in the online version at DOI:10.1016/j. interventions to reduce procedural pain and mental distress
burns.2017.11.019). in adults undergoing burn wound care.

4.1. Summary of the evidence

4. Discussion
We identified 21 studies meeting our inclusion criteria of
Aim of the present review was to summarize the existing which 18 studies reported effects on pain relief and 12 on
evidence on the efficacy of non-pharmacological anxiety reduction, respectively. Results revealed a significant

Table 2 – Stratified results on pain for comparisons against treatment as usual.

Hedges’ g 95% CI k p Heterogeneity

Q (df) p I2
Pain outcome
Pain intensity 0.58 0.33; 0.83 15 <0.001 45.12 (14) <0.001 69.0
Pain unpleasantness 1.06 0.63; 1.50 6 <0.001 18.74 (5) 0.002 73.3
Time spent thinking about pain 1.37 0.73; 2.01 5 <0.001 22.97 (4) <0.001 82.6
Type of intervention
Distraction 0.83 0.47; 1.18 7 <0.001 18.41 (6) 0.005 67.4
Distraction (VR only) 0.94 0.60; 1.28 6 <0.001 13.16 (5) 0.022 62.0
Hypnosis 0.88 0.45; 1.30 3 <0.001 1.42 (2) 0.492 0.0
Relaxation + distraction 0.57 0.19; 0.94 3 0.003 3.31 (2) 0.191 39.7
Relaxation 0.20 1.30; 0.90 2 0.724 3.59 (1) 0.058 72.1

VR =virtual reality.

Please cite this article in press as: M. Scheffler, et al., Efficacy of non-pharmacological interventions for procedural pain relief in adults
undergoing burn wound care: A systematic review and meta-analysis of randomized controlled trials, Burns (2017), https://doi.org/
10.1016/j.burns.2017.11.019
JBUR 5437 No. of Pages 12
10 burns xxx (2017) xxx –xxx
positive medium effect of non-pharmacological interventions
on all pain outcomes, and a significant positive small effect on
anxiety. Effects of non-pharmacological interventions on pain
relief were significantly larger when compared to TAU than to
attention control.
However, single study effects on pain varied considerably
leading to a substantial statistical heterogeneity of the total
effect though it decreased by excluding one outlying study.
Moreover, the internal validity of the included studies might be
limited mostly because of an observed risk of performance
bias. Most of the included trials further had small sample sizes
leading to an insufficient precision of the study results.
When considering different components of pain separate-
ly, we found large effects on pain unpleasantness reflecting
the emotional component of pain and time spent thinking
about pain covering the cognitive component of pain; results
further revealed medium effects on pain intensity represent-
ing the sensory component of pain.
Distraction interventions, particularly treatments using
virtual reality, as well as hypnosis yielded the largest effects on
pain relief. The application of distraction is based on the
assumption that the experience of pain is largely cognitively
controlled. According to the gate-control mechanism [7], the
interpretation of an incoming neural signal as more or less
painful depends on where patients focus their attention at this
time. Effective distraction techniques require substantial
attention by the patient, resulting in the withdrawal of attention
away from the painful stimulus. Particularly virtual reality
distraction draws a significant amount of attention into another
world, leaving less attention available to process pain signals
[6].
All studies examining the efficacy of hypnosis used
hypnotic analgesia by applying Barber’s RIA protocol [16].
Hypnotic analgesia is thought to reduce pain through changes
in cognitions altering the affective states related to pain. It has
been demonstrated that hypnotic analgesia is associated with
neurophysiological changes, i.e., an inhibition of afferent
nociceptive signals arriving at the somatosensory cortex and a
modulation of pain affect by inducing changes in the limbic
system [52,53].
All studies providing VR distraction, hypnosis, or a
combination of relaxation and distraction showed significant
positive effects. Only one study at all [50] showed significant
negative effects on pain. The authors state that this effect
might be attributable to the statistical analysis in which pre-
existing differences in pain between the intervention and the
control group were not considered.
4.2. Agreements with other reviews
This is the first meta-analysis on the efficacy of non-
pharmacological interventions applied as an adjunct to
standard burn wound care. So far, only one systematic review
[9] comprehensively summarized the evidence in this field. All
of our included studies published until 2007 are part of this
review, too. de Jong et al. concluded in their review that there
was a lack of randomized-controlled designs, overall and per
intervention. With updating the review and expanding the
numbers of studies included we could more than double the
considered evidence.
Please cite this article in press as: M. Scheffler, et al., Efficacy of non-pharmacological interventions for procedural pain relief in adults
undergoing burn wound care: A systematic review and meta-analysis of randomized controlled trials, Burns (2017), https://doi.org/
10.1016/j.burns.2017.11.019
While a few further systematic reviews summarized the
evidence on single types of non-pharmacological interven-
tions in burn wound care [17,18], meta-analytic estimates were
provided only in two reviews. The first focused on the efficacy
of hypnosis in patients undergoing surgery or painful medical
procedures [54]. In this meta-analysis, a significant medium
effect of hypnosis in a subgroup of adults undergoing burn
wound care on pain intensity was reported. Besides the five
studies included in the subgroup of burn care studies by
Tefikow et al., our review comprised one additional study [43].
In a recent meta-analysis on the efficacy of music interven-
tions in burn patients including 17 studies [19], large effects
were found in favor of music both in reducing pain and anxiety.
However, more than half of the studies were reported in
Chinese and could not be considered in our review. Of the eight
studies in English language, we included five studies (we did
not consider two trials with children and another one focusing
on background pain).
Hypnosis (RIA), distraction and relaxation are particularly
recommended in the current European Guidelines for Burn
Care published in 2015 by the European Burns Association [55].
Likewise, the German evidence- and consensus-based guide-
lines on the management of analgesia, sedation and delirium
in intensive care attributed the use of virtual reality in burn
patients with the highest level of evidence [56].
In contrast, non-pharmacological interventions are not
commonly used in burn wound care despite of increasing
evidence for beneficial effects. It is often argued that advanced
expertise, time and efforts required by clinicians might limit
their application [1]. However, in the last years novel treatment
approaches using virtual reality have been developed and
evaluated that might be applied in settings with limited
resources. Particularly, virtual reality distraction has been
determined as highly efficacious approach in our meta-
analysis. Virtual reality systems, once developed, could be
applied without great time and effort in clinical routine care
[57]. Further economically applicable approaches might
comprise hypnosis or relaxation instructions, e.g., delivered
pre-recorded during care procedures.
4.3. Limitations
The meta-analysis reported here combines data across studies
in order to estimate treatment effects with more precision
than is possible in a single study. The main limitation of this
meta-analysis, as with any overview, is that the patient
populations, the settings, the applied interventions and the
outcome definitions are not the same across studies. This
clinical diversity might have led to unexplained heterogeneity.
The resulting uncertainty about the true effect of non-
pharmacological interventions constitutes a weakness of
the present review. Another limitation of the selected studies
was the sample size; only four studies included more than
50 subjects leading to imprecision of the results. Only three of
the included studies are adequately powered (with a =0.05 and
a power of 0.80) regarding the mean effect of pain, for anxiety
no study is adequately powered. In contrast, our meta-
analyses have a power of 0.99 for pain and 0.83 for anxiety
to detect differences with a =0.05 given a mean sample size of
30 participants and considering the degrees of heterogeneity
JBUR 5437 No. of Pages 12
burns xxx (2017) xxx –xxx
[58]. Hence, our meta-analyses achieved to enhance the power
that is usually not given in the primary studies [59].
Furthermore, the internal validity of the included studies
might be limited. Only three studies were able to blind
participants by using an attention-control design. A study
protocol could be found only for two studies suggesting a low
risk of reporting bias just for a minority of trials. Risk of
performance bias was present in ten of the included studies;
another five studies did not report sufficient information for a
judgment. Quality of reporting was also a problem in assessing
the risk of selection bias; more than half of the studies did not
allow for an informed decision with respect to randomization
and allocation concealment.
Despite we used multiple databases for our literature
search and manually went through reference lists of selected
articles, our search strategy could have missed some studies.
Although our search included all years until 2016, the latest
study meeting our inclusion criteria was published in 2013 [51].
Moreover, we could not identify any unpublished material;
however, there was no indication for a publication bias to be
present. Finally, we were not able to run some subgroup
analyses due to the small sample of included studies and
resulting lack of power.
4.4. Conclusions
In general, non-pharmacological interventions in treating
burn pain may be useful as adjunct to pharmacological
standard care. According to the current status of evidence,
particularly VR distraction, hypnosis, and a combination of
relaxation and distraction could be recommended for relieving
pain and reducing anxiety during burn wound care in addition
to standard pharmacological approaches. However, further
research is needed to strengthen the promising evidence for
the efficacy of non-pharmacological interventions. We en-
courage the proliferation of large-scale studies complying with
high validity standards to reduce imprecision and bias. Future
investigations should further pay attention to investigating
covariates of treatment effects such as patient characteristics
as well as patient-treatment interactions, because there were
some studies including a considerable proportion of patients
who do not benefit from the respective intervention. Accurate
knowledge of the mechanisms of the interventions would help
to optimize treatment approaches and tailor them to the needs
of the individual patient [9].
Conflict of interest statement
The authors declare no conflicts of interest.
Contributions
MS and JR drafted the protocol, developed a search strategy,
searched for studies, obtained copies of studies, selected
which studies to include, extracted data from studies, and
drafted the final write-up of the review. SK, WM, and BS
supported the interpretation of the analyses and co-authored
sections of the review.
Please cite this article in press as: M. Scheffler, et al., Efficacy of non-pharmacological interventions for procedural pain relief in adults
undergoing burn wound care: A systematic review and meta-analysis of randomized controlled trials, Burns (2017), https://doi.org/
10.1016/j.burns.2017.11.019
11
Acknowledgement
This research did not receive any specific grant from
funding agencies in the public, commercial, or not-for-profit
sectors.
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