Post on 21-Apr-2023
Virtual reality for acute pain reduction in adolescentsundergoing burn wound care: A prospective randomizedcontrolled trial
Belinda Kipping a,b,c,d,*, Sylvia Rodger b, Kate Miller a,b,c,d, Roy M. Kimble a,c
aThe Centre for Children’s Burns and Trauma Research, Queensland Children’s Medical Research Institute, The Department of Paediatrics and
Child Health, The University of Queensland, Royal Children’s Hospital, Brisbane, AustraliabThe University of Queensland, School of Health and Rehabilitation, Division of Occupational Therapy, Brisbane, AustraliacThe University of Queensland, School of Medicine, Department of Paediatrics and Child Health, Brisbane, AustraliadDepartment of Occupational Therapy and Music Therapy, Royal Children’s Hospital, Brisbane, Australia
b u r n s 3 8 ( 2 0 1 2 ) 6 5 0 – 6 5 7
a r t i c l e i n f o
Article history:
Accepted 17 November 2011
Keywords:
Pain
Distraction
Virtual reality
Adolescent
Pediatric
Burns
a b s t r a c t
Background: Effective pain management remains a challenge for adolescents during con-
scious burn wound care procedures. Virtual reality (VR) shows promise as a non-pharma-
cological adjunct in reducing pain.
Aims: This study assessed off-the-shelf VR for (1) its effect on reducing acute pain intensity
during adolescent burn wound care, and (2) its clinical utility in a busy hospital setting.
Methods: Forty-one adolescents (11–17 years) participated in this prospective randomized
controlled trial. Acute pain outcomes including adolescent self-report, nursing staff behav-
ioral observation, caregiver observation and physiological measures were collected. Length
of procedure times and adolescent reactions were also recorded to inform clinical utility.
Results: Nursing staff reported a statistically significant reduction in pain scores during
dressing removal, and significantly less rescue doses of Entonox given to those receiving VR,
compared to those receiving standard distraction. For all other pain outcomes and length of
treatment, there was a trend for lower pain scores and treatment times for those receiving
VR, but these differences were not statistically significant.
Conclusion: Despite only minimal pain reduction achieved using off-the-shelf VR, other
results from this trial and previous research on younger children with burns suggest a
customized, adolescent and hospital friendly device may be more effective in pain reduction.
# 2012 Published by Elsevier Ltd and ISBI.
Available online at www.sciencedirect.com
journal homepage: www.elsevier.com/locate/burns
1. Introduction
The pain experienced during burn wound care is clinically well
known, yet poorly researched in adolescents. Due to the
nature of burns, repeated painful wound care dressing
changes are required regularly to facilitate wound healing.
Effective pain management associated with these procedures
* Corresponding author at: Centre for Children’s Burns and Trauma ReFoundation Building, Royal Children’s Hospital, Brisbane, QLD 4029, A
E-mail address: belinda.kipping@uqconnect.edu.au (B. Kipping).
0305-4179/$36.00 # 2012 Published by Elsevier Ltd and ISBI.doi:10.1016/j.burns.2011.11.010
remains a challenge for burn healthcare professionals around
the world. Adjunctive non-pharmacological techniques are
often combined with routine pharmacological protocols. Even
with this multimodal approach, current pain management
practices are still considered inadequate [1–4].
The pain and trauma associated with medical procedures
such as burn wound care does not always end with the
procedure. There is increasing recognition of the short and
search, Queensland Children’s Medical Research Institute, Level 4,ustralia. Tel.: +61 7 3365 5338; fax: +61 7 3365 5455.
Table 1 – VAS descriptors used in this trial.
Pain 0 = no pain, 10 = pain as bad as it
could possibly be
Presence 0 = not at all, 10 = totally went into
the game world
Nausea 0 = no sick tummy, 10 = sick tum-
my as bad as it could possibly be
b u r n s 3 8 ( 2 0 1 2 ) 6 5 0 – 6 5 7 651
long term consequences that can result from these experi-
ences, particularly for those who have not reached adulthood
[1,5–7]. Reported examples include increased sensitivity to
pain and poor psychological well-being and functioning [5–7].
The range of adjunctive non-pharmacological interven-
tions available for use in pediatric and adolescent acute pain
management is wide and varied. Psychological and distrac-
tion-based (also referred to as attention-based [8]) approaches
such as, hypnosis, parental participation, music, movies and
virtual reality (VR) related technologies have featured in the
literature [9–14].
VR technology is a promising adjunctive pain management
tool for adolescents, as demonstrated by some successful
trials with children and adults [14–16]. Evidence in the
adolescent age range and burn wound care context is limited
by small sample sizes [13,15]. Its mechanism of action is
attributed to the gate control theory of pain [17]. In
acknowledgement of budgetary limits commonly associated
with healthcare, this trial chose a VR system that was
accessible and affordable (off-the-shelf VR), over more
expensive and customized hardware and software options.
The following research questions were designed to build on
the current lack of evidence. For adolescents (11–17 years)
undergoing burn wound care, does off-the-shelf VR reduce
pain levels more than standard distraction? In terms of clinical
utility in an acute hospital environment, does it reduce length
of wound care procedures and with no adverse reactions? It
was hypothesized that the adolescents who received off-the-
shelf VR during their wound care procedure would experience
less pain intensity and reduced treatment times than those
who received standard distraction.
2. Methods
This study was a prospective randomized controlled trial (RCT)
with a parallel group design. Ethics approval for this project
was obtained from the Royal Children’s Hospital (RCH), Royal
Brisbane and Women’s Hospital (RBWH), and The University
of Queensland, Human Research Ethics Committees.
2.1. Participants
Between November 2008 to February 2010, adolescents (11–17
years) were recruited across two neighboring tertiary hospital
sites; 10–14 years from the Stuart Pegg Paediatric Burn Centre
(SPPBC) RCH and 15–17 years from Stuart Pegg Adult Burn Unit
(SPABU) RBWH, Brisbane, Australia. Inclusion criteria were; (1)
adolescents 11 to <18 years, (2) attendance at SPABU or SPPBC,
(3) first conscious change of dressing, and (4) burn wound Total
Body Surface Area (TBSA) greater than 1%. Exclusion criteria
were: (1) cognitive impairment preventing the use of outcome
measures, (2) visual/hearing impairment unable to be cor-
rected, (3) wound location impacting the ability to use the off-
the-shelf VR device, (4) non-English speaking, and (5) child
safety and protection issues. Sample size calculations indicat-
ed at least 16 participants were required in each group for
between group analysis (with a power 0.8, Type I error rate
0.05, and a 2.0 point reduction on a 10.0 point Visual Analogue
Scale, VAS).
2.2. Clinical outcomes
Pain intensity measures included the VAS [18] for adolescent
self-report and caregiver observations and Faces, Legs,
Activity, Cry, Consolability (FLACC) Scale [19] for nursing staff
observations as well as physiological parameters of heart rate
and oxygen saturations. These were chosen based on; (1) the
evidence that supports their use within this age range and
clinical context, (2) their ease of use and nursing staff
familiarity, and (3) PedIMMPACT recommendations [4,14,20].
2.2.1. Visual analogue scale (VAS) [18]The VAS was a 10 cm horizontal line with each end anchored
by word descriptors (see Table 1 for VAS word descriptors used
in this trial). Test–retest reliability for the VAS in previous
studies showed strong correlations (r = .99) in adolescents
during acute medical procedures [21]. Inter-rater reliability
correlated highly with pain measurement when completed by
nursing staff post-operatively [21,22]. Recent researchers
using the VAS to measure pain outcomes with VR related
technology with younger children have also used the VAS with
caregivers [14,23]. In the current study, the VAS was used for
adolescent self-report and caregiver observation.
2.2.2. Faces, legs, activity, cry, consolability (FLACC) scale [19]The FLACC scale is another well-established pain measure-
ment tool, with extensive reliability and validity data
[19,20,24]. Highly recommended in clinical trials, it is reported
to have excellent inter-rater reliability (r = 0.87) [25], as well as
good concurrent validity with the VAS [20]. The nursing staff
provided scores for each of the five measurement categories
(faces, legs, activity, cry and consolability) on a scale of 0–2
(using the word descriptions that best describe the behavior
for each category). A total pain score out of a maximum 10 was
provided by nurses at three time intervals.
2.2.3. Physiological measuresHeart rate and oxygen saturations were also recorded, using a
pulse oximeter machine, with a sensor placed on the
adolescent’s finger or toe. It is acknowledged that the use of
physiological measures is contentious due to reports of weak
to moderate correlations between physiological changes and
painful events [26], and the potential influence from other
variables such as fear, anxiety, and exertion [20,27]. Despite
this, objective physiological outcome measures such as these
are still recommended to ensure a comprehensive approach
when conducting clinical pain trials [4,20,28].
2.2.4. Adolescent reactionsAdolescent reactions were monitored during VR using VAS
[18]. These included self-report of ‘‘presence’’; defined as ‘‘the
subjective experience of being in one place or environment,
Fig. 1.1 – Picture of an adolescent using the off-the-shelf VR
system.
b u r n s 3 8 ( 2 0 1 2 ) 6 5 0 – 6 5 7652
even when one is physically situated in another’’ (p. 225) [29],
and self-report of nausea to monitor for any potential
simulator sickness that can sometimes be associated with
VR use [13,30].
2.3. Procedures
Written informed consent (and adolescent assent) was
obtained from caregivers prior to randomization. Random
sequence was computer generated (1:1, blocks of 20),
concealed in consecutively numbered sealed opaque envel-
opes, and opened by an independent staff member (adminis-
tration officer). Both groups received identical wound care
procedures and medication protocols, and participation was
for the first conscious change of dressing only.
Using a standard script, the primary investigator (PI) who
was present at each burn dressing recorded the clinical
outcome measures from adolescent (VAS), caregiver (VAS) and
nursing staff (FLACC) at three time points namely; (T1)
baseline (prior to randomization and procedure commence-
ment), retrospectively after dressing removal (T2) and dress-
ing application (T3). The PI also recorded pain physiological
measures at 2-min intervals, and the length of procedure (of
dressing removal and dressing application) in minutes. All
outcome measure responses were recorded by the participant,
his/her caregiver and nurse unobtrusively placing a mark on
the data collection sheet, to minimize the risk of bias of
overhearing responses from those involved.
2.4. Interventions
The VR group (VRG) received distraction via an off-the-shelf
VR system, which included a head mounted display (eMagin,
Z800 3DVisor with headtracking and 2 high contrast SVGA
resolution 800 � 600 16.7 million colours), joystick hand
control (LOGIK PC ATTACK 3), personal computer and off-
the-shelf, age appropriate software games (Chicken LittleTM
for the 11–13 years old, and an additional choice of Need for
SpeedTM for the 14–17 years old). The VRG accessed the off-
the-shelf VR system in their individual treatment room a few
minutes prior to the commencement of the procedure. See Fig.
1.1.
The standard distraction group (SDG) had access to TV,
stories, music, caregivers or no distraction in the treatment
room as was their choice and as per standard practice at SPPBC
and SPABU.
2.5. Statistical analysis
SPSS 18.00TM program was used for all statistical analyses.
Normality and baseline homogeneity between groups was
assessed to ensure similarity at baseline. Intention to treat
analysis was completed with all participants analyzed as
allocated, with omission of missing pain report data for the
one participant specific to the dressing application phase only
(representing only 2.4% of total sample). Differences between
groups were analyzed using independent samples t-tests for
pain intensity (VAS and FLACC change scores, heart rate mean
scores), length of dressing removal in minutes and nausea
change scores. Change scores (i.e. T2 minus T1) were used to
take into account baseline data for each group, where
applicable. Where the data were not normally distributed
(i.e. length of dressing and oxygen saturations) Mann–
Whitney U tests were performed. Frequency of adolescents
requiring rescue doses (medication prescribed after com-
mencement of the procedure) of Entonox and adverse
reactions were also compared using a Chi-square test.
Descriptive data on the level of presence are also illustrated
in the results section.
3. Results
3.1. Sample
The consort diagram (Fig. 2.1) illustrates a total of 132
adolescents were assessed for their eligibility, with 41
randomized and 91 excluded (69 not meeting inclusion
criteria, 6 declining to participate and 16 missed due to first
dressing change occurring out of work hours, or attendance
missed). All participants received their treatment as allocated,
however one participant withdrew from the trial (intervention
group) halfway through the dressing change, as the adolescent
reported not wanting to continue playing with VR. There were
no significant differences between groups at baseline for any
measures (age, TBSA, sex, depth of burn, mode, location of
care, admission status, and dressings used and medications
given) (see Table 2).
3.2. Pain intensity
Mean difference in pain scores (change scores) reported by
adolescents, caregivers and nursing staff for each group are
provided in Table 3. For adolescent self-report of pain, mean
pain scores were higher for the SDG compared to the VRG in
both dressing removal and application, however these
differences were not statistically significant (Fig. 3.1). Nursing
staff observations using FLACC revealed statistically signifi-
cant differences between VRG and SDG during dressing
removal, with less pain behaviors observed for the VRG.
Assessed for eligibility (n=132)
Excluded (n=91)Not meeting inclusion criteria (n=69)Declined to participate (n=6) Other reasons (n=16) Missed as not
told, attended out of work hours, orprimar y investigator away on leave
Analysed (n=20)Excluded from analysis (n=0 )
Lost to follow-up (n=0)
Discontinued intervention (participant refused,reporting did not want to keep using VR) (n=1)
Allocated to VRG (n=20)Received allocated intervention (n=20)Did not receive allocated intervention (n=0 )
Lost to follow-up (n=0)
Discontinued intervention (n=0)
Allocated to SDG (n=21)Received allocated intervention (n=21)Did not receive allocated intervention (n=0)
Analysed (n=21)Excluded from analysis (n=0 )
Allocation
Analysis
Follow-Up
Randomized (n=41)
Enrollment
Fig. 2.1 – CONSORT flow chart.
Table 2 – Baseline demographic characteristics.a
SDG (n = 21) VRG (n = 20) Total (n = 41) p-Value
Age, years 13.5 (1.8) 12.6 (1.3) 13.08 (1.6) p = 0.08
TBSA, % 4.7 (4.5) 5.1 (6.3) 4.9 (5.4) p = 0.93
Sex, male 15 (71.4%) 13 (65%) 28 (68.3%) p = 0.92
Depth p = 0.90
Superficial partial dermal thickness 9 (42.9%) 8 (40%) 17 (41.5%)
Deep dermal partial thickness 8 (38.1%) 7 (35%) 15 (36.6%)
Full thickness 4 (19%) 5 (25%) 9 (22%)
Mode p = 0.86
Scald 5 (23.8%) 7 (35%) 12 (29.3%)
Contact 2 (9.5%) 2 (10%) 4 (9.8%)
Flame 8 (38.1%) 7 35(%) 15 (36.6%)
Friction 6 (28.6%) 4 (20%) 10 (24.4%)
Location of care p = 0.37
SPPBC 17 (81%) 19 (95%) 36 (87.8%)
SPABU 4 (19%) 1 (5%) 5 (12%)
Admission Status p = 1.0
Inpatient 7 (33.3%) 6 (30%) 13 (31.7%)
Outpatient 14 (66.7%) 14 (70%) 28 (68.3%)
Dressings p = 1.0
ActicoatTM 18 (85.7%) 17 (85%) 35 (85.4%)
Petroleum-based 3 (14.3%) 3 (15%) 6 (14.6%)
Medication p = 0.57
Nil 1 (4.8%) 2 (10%) 3 (7.3%)
Opioid 18 (85.7%) 14 (70%) 32 (78%)
Opioid and other (i.e. paracetamol, Entonox) 2 (9.5%) 3 (15%) 5 (12.2%)
Paracetamol and Entonox 0 (0%) 1 (5%) 1 (2.4%)
a Data are means (SD) or numbers (%).
b u r n s 3 8 ( 2 0 1 2 ) 6 5 0 – 6 5 7 653
Table 3 – Mean change scores for pain intensity and nausea.a
SDG VRG p-Value
Adolescent VAS dressing removal 4.2 (3.2) 2.9 (2.3) p = 0.16
Adolescent VAS dressing application 3.8 (3.6) 2.33 (3.4) p = 0.40
Nursing staff FLACC dressing removal 4.7 (2.5) 2.9 (2.4) p = 0.02b
Nursing staff FLACC dressing application 3.0 (2.8) 1.9 (2.8) p = 0.23
Caregiver VAS dressing removal 3.8 (3.2) 3.5 (2.5) p = 0.71
Caregiver VAS dressing application 2.2 (4.0) 2.6 (3.5) p = 0.75
Nausea dressing removal �0.3 (1.5) �0.7 (1.1) p = 0.27
Nausea dressing application �0.5 (1.3) �0.3 (1.0) p = 0.65
a Data are means (SD).b Statistically significant.
2
6.2 5.3
1.6
4.6 3.9
0
2
4
6
8
10
Baseline DressingRemoval
DressingApplication
Mean painscore
Standard Deviation
Virtual Reality
Fig. 3.1 – Adolescent self-report of pain (VAS).
0.5
5.1*3.5
0.3
3.1 2.2
0
2
4
6
8
10
Baseline DressingRemoval
DressingApplicatio n
Mean painscore
Standard Deviation
Virtual Reality
Fig. 3.2 – Nursing staff behavioral of adolescent pain
(FLACC).
b u r n s 3 8 ( 2 0 1 2 ) 6 5 0 – 6 5 7654
However this difference was not seen during dressing
application, despite a lower mean score in the VRG (Fig. 3.2).
There were also no significant differences between the groups
for caregiver ratings of adolescent pain ( p > 0.05) (Fig. 3.3).
There were no statistically significant differences found
between the groups for mean heart rate or oxygen saturation
( p > 0.05). Notably, the VRG recorded rescue doses of Entonox
for 3/20 (15%) adolescents, whereas the SDG recorded 9/21
(43%) adolescents, representing a statistically significant
difference ( p = 0.05).
3.3. Adolescent reactions and adverse events
No adverse events relating to VR use were observed or
reported and there were no differences between groups for
nausea (Table 3). Throughout the dressing procedure, a large
proportion of adolescents reported significant pain (defined in
this and a previous similar trial as ‘‘moderate to severe’’ �4/10
on VAS [31,32]), and subsequently were recorded as experienc-
ing an adverse procedural pain event. More adolescents in the
2.3
6.3
1
4.5
0
2
4
6
8
10
Baseline DressinRemov
Mean painscore
Fig. 3.3 – Caregiver observation
SDG during dressing removal (15/21, 72%), and dressing
application (12/21, 58%) experienced a procedural adverse
pain event compared to the VRG (12/20, 60% during dressing
removal, and 6/19, 32% during dressing application, although
this difference was not significant ( p > 0.05). The mean
presence rated by all VRG participants (n = 20) using a VAS,
revealed a mean (SD) of 6.1 (�3.1) out of 10.
3.4. Length of treatment
Length of treatment times ranged from 2 to 62 min for
dressing removal and 2–58 min for dressing application. For
dressing removal both groups had a median time of 8 min
(VRG IQR = 4.5–15.5 min, and SDG IQR = 6–24 min). For dress-
ing application the VRG had a lower median time of
10 minutes (IQR = 4–20 min) compared to the SDG median
of 12 min (IQR = 9–20 min). A Mann–Whitney U test revealed
no significant difference between the groups for length of
removal ( p > 0.51) or application ( p > 0.33) of dressings (see
Fig. 3.4).
4.5
3.6
gal
DressingApplication
Standard Deviation
Virtual Reality
of adolescent pain (VAS).
5 100 15 20 25 30 35 40 45 50 55 60 65
VR
SD
VR
SD
Minutes
DressingRemoval
DressingApplication
Fig. 3.4 – Length of treatment times.
b u r n s 3 8 ( 2 0 1 2 ) 6 5 0 – 6 5 7 655
4. Discussion
This trial focused on non-pharmacological pain relief for the
underrepresented age range of adolescence in the context of
burn wound care. To the authors’ best knowledge this is the
first randomized controlled trial focusing on VR for adolescent
pain reduction during burn wound care. It provides valuable
insights into the clinical effectiveness and utility of an
affordable off-the-shelf VR system.
Firstly, the results demonstrated there were no consistent
statistically significant differences in pain during burn wound
care between groups. Notably for those adolescents in the
VRG, there was a statistically significant pain reduction
observed by nursing staff during dressing removal, a statisti-
cally significant reduction in the number of rescue Entonox
doses given, and a trend for the mean pain scores to be lower,
compared to the SDG. There was also overall consensus in
mean pain scores between adolescents, nursing staff and
caregivers, that dressing removal was more painful than
dressing application.
Fewer adolescents in the VRG were recorded as experienc-
ing an adverse procedural pain event, compared to the SDG.
While this off-the-shelf VR system was not effective in
significantly reducing pain, these are still promising clinical
benefits. The suggestion that VR can assist with pain reduction
during adolescent burn wound care, concurs with results from
previous trials and pilots involving the use of more customized
virtual reality related technologies with adolescent samples
[13,15] and children undergoing burn wound care [14,31]. This
trial highlights the limitations of affordable off-the-shelf
systems for engagement and distraction from pain.
This off-the-shelf system had no significant effect on
treatment times, compared to the standard distraction
options. The presence scores recorded during this trial while
positive still indicate room for improvement, in regard to the
level of immersion experienced by adolescents using this VR
system. In line with the gate control theory of pain [17], the
more attention that is engaged in virtual reality and distracted
away from the painful experience, the more effective the pain
relief. As greater pain reductions were reported in trials
involving customized systems [13–15,31], this guides the
direction of future research and development. For example
customizing a VR system to improve the motivational
relevance, as suggested by Verhoeven et al., may enhance
the effectiveness of distraction and subsequently enhance
pain reduction [33]. Another consideration for future research
which this trial did not focus on, is the impact of VR over
multiple and consecutive dressing changes. Information on
the longer term use of VR can provide meaningful insights
such as the impact on procedural anxiety and the mainte-
nance of reduced pain score for the first and subsequent
dressing changes [14].
Investigating the effectiveness and clinical usability of
affordable virtual reality systems is necessary in our current
economic climate and with growing health care demands.
This highlights the complexity of the pain experience and
fuels the ongoing discussion in the literature on what is the
minimum clinically meaningful reduction in pain [34–36], and
how much health systems will pay for it. This trial suggests
that savings made on purchasing an off-the-shelf system, will
not result in meaningful or effective reductions in pain.
Further research is required to confirm the minimum
clinically meaningful reduction in pain, and also identify
the qualities of a customized VR system that will engage
adolescents’ attention enough to reduce pain, as well as meet
burn wound procedure (i.e. infection control, waterproofing,
time, training and space implications) and financial require-
ments.
5. Limitations
Measurement of pain is challenging and assessment of pain
intensity alone does not capture the multidimensional nature
of pain. Due to the burden of other pain outcome measures
during a real life traumatic experience, only pain intensity was
assessed in this trial. Blinding of participants and staff is also
acknowledged as a limitation as it is extremely difficult to
achieve in trials with distraction interventions. Strategies to
reduce the impact include preventing participants from seeing
their allocated distraction intervention until in a private
treatment room.
6. Conclusions
This RCT of adolescents (11–17 years) using off-the-shelf VR
did not reduce pain levels, length of treatment times or
adverse pain events more than standard distraction. While
adolescents exposed to VR had a trend of lower mean pain
scores, the only difference that reached statistical significance
was for nursing staff observation during dressing removal.
Notably, the number of adolescents using off-the-shelf VR
received significantly fewer rescue doses of Entonox, com-
pared to those in the SDG. This paper highlights the need for
further investigation of customized VR which may further our
understanding of the relationship between VR distraction and
pain reduction in the adolescent age range.
Conflict of interest
This study was supported financially by a grant given to the
Royal Children’s Hospital, Brisbane by Diversionary Therapy
Technologies (DTT). DTT did not contribute in any way to the
b u r n s 3 8 ( 2 0 1 2 ) 6 5 0 – 6 5 7656
study design, data collection or analysis of results from this
clinical trial. Roy Kimble part-supervised this trial and also
holds options with this company, however at the time of
completion and submission of this clinical trial, will not stand
to lose or gain financially or personally from the results. The PI,
Kate Miller and Sylvia Rodger remain employees of the Royal
Children’s Hospital and University of Queensland respective-
ly, and have no financial interest in the results, products or
DTT.
Acknowledgments
Sincere thanks to Ristan Greer for her friendly encouragement
and statistical support, as well as the SPPBC and SPABU
nursing teams for their patience and assistance during this
project.
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