Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04538573 |
| Other study ID # |
MOBILE |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 27, 2022 |
| Est. completion date |
May 30, 2024 |
Study information
| Verified date |
November 2023 |
| Source |
St. Justine's Hospital |
| Contact |
Sylvie Le May, PhD |
| Phone |
514-345-4931 |
| Email |
sylvie.lemay[@]umontreal.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background
In the acute phase, burn patients undergo several painful procedures. Pediatric burn care
procedures conducted in hydrotherapy have been known to generate severe pain intensity and
moderate to high levels of anxiety. Hydrotherapy treatments are done with the use of opioids
and benzodiazepines for pain and anxiety. Unfortunately, non-pharmacological methods are
rarely combined with pharmacological treatments despite evidence showing that distraction can
serve as an effective method for pain management and can potentially decrease analgesic
requirements in other painful medical procedures. Virtual Reality (VR) is a method that uses
distraction to interact within a virtual environment. The use of VR is promising for pain
reduction in varying settings. Considering the lack of optimal pain and anxiety management
during burn wound care and the positive effect of an immersive distraction for painful
procedures, using VR for burn wound care procedures may show promising results.
Methods
This is a within-subject randomized controlled trial design in which each participant will
serve as his/her own control. A minimum of 20 participants, aged 7 to 17 years old undergoing
a burn care session, will receive both standard and experimental treatments during the same
session in a randomized order. The experimental treatment will consist of combining VR
distraction using the video game Dreamland® to the current standard pharmacological care as
per unit protocol. The control group will only receive the unit's standard pharmacological
care. The mean difference in both pain intensity scores and in anxiety between the two
different sequences will be the primary outcomes of this study.
Conclusion
This study evaluates the effect of VR on burn wound care. If results from this study show a
positive effect of VR compared to standard care, this protocol may provide guidance on how to
implement this type of immersive care as part of the tools available for distraction of
painful procedures for acute burn victims.
Description:
BACKGROUND
Pediatric burn care procedures in hydrotherapy have been known to generate severe pain
intensity as well as moderate to high levels of anxiety. In the acute phase, burn patients
undergo several painful procedures including wound debridement, passive range-of-motion (ROM)
exercises and dressing change treatments. These procedures are important for proper
rehabilitation as they prevent contractures, muscle spasms and limited joint mobility. These
possible complications result from the normal healing process following a burn injury and are
mainly due to scarring and loss of skin elasticity .1,2
Hydrotherapy in burn care is done with the use of opioids and benzodiazepines, since regular
analgesics, such as acetaminophen alone, are often inadequate for pain and anxiety
management.3,4 As hydrotherapy treatments cause a great deal of pain compared to standard
burn care, high dose of narcotics is required to reach an acceptable level of pain relief.
The delicate balance between pain relief and opioid requirements is often at the limit of
respiratory depression and the occurrence of side effects such as nausea and vomiting.
Unfortunately, non-pharmacological methods are rarely combined with the pharmacological
treatments used to relieve pain during hydrotherapy even if they could decrease the necessary
dose of analgesics and benzodiazepines.
Virtual Reality (VR) is a method that uses distraction to interact within a virtual
environnement.3 Flexibility and variety of content make of VR a promising tool for pain
reduction, able to be adapted to procedures and to different patient.5-8 Other positive
effects including reduction of anxiety for painful procedures have been reported by children
and adults. 9-12 Furthermore, recent randomized-controlled trials 9,10 comparing VR and
standard distraction in children during painful procedures demonstrated a significant effect
on pain and anxiety which enhanced patients', caregivers' and phlebotomist's satisfaction.
Also, Gold and Maher 10 concluded that children with higher anxiety sensitivity had better
results, adding support for the adoption of this new technology in children's health care.
However, VR is also associated with certain side effects such as an increased nausea and the
feeling of cybersickness. 13,14
Only a few authors have studied the effect of VR on procedural pain and anxiety management in
burn children older than 6 years old. Indeed, a review of the literature has yielded only
three studies who used VR with burn children.1,3,15 A study compared the efficacy of VR with
standard pharmacological care in an RCT on 54 children (6 to 19 years) suffering from
burn-related injuries with TBSA (Total Body Surface Area) varying from 1% to >50%.1 Results
showed better pain control and maximum ROM in children in the VR group.1 Another study
combined participants from three studies (to increase power) to compare the use of VR with
standard pharmacological care with children undergoing physical therapy following a major
burn.15 Results on 110 children also showed that VR significantly decreased pain and
unpleasantness related to pain in children with burns.15
Furthermore, Virtual Reality has shown positive effects with burn children who underwent
hydrotherapy sessions and dressing changes.16-18 However, very few studies have looked at the
effect of VR on the management of pain, anxiety and recall of both in children undergoing
painful burn wound care. Distractions are an interesting non-pharmacological method that can
be used and we believe that a VR distraction as an adjunct to current burn care (standard
pharmacological treatment), could be easily adopted by hydrotherapy staff as part of their
care as it is an easy to use and low-cost intervention. Other successful VR studies have
shown a high satisfaction level among healthcare workers. Their satisfaction level is
important for the feasibility aspect of the study as the uptake of the intervention and its
acceptability may influence the possibility of such interventions being implemented at a
larger scale in a hospital setting. 19Also, we believe that it could help make the overall
recovery process less painful and less stressful for burn children.
Evidence shows that short-term procedural pain and anxiety can leave long lasting effects on
children20 even after the end of the procedure which is why it is also important to pay
attention to the way they remember these experiences.21,22 Children negatively recalling past
pain experiences (i.e., they recall more pain than an earlier pain report) will most likely
experience more pain in future experiences, could develop chronic pain problems,21,22 fears
and avoidance of medical care.23 These negatively based memories seem to be developed prior
to painful procedures by anxious and distressed children experiencing higher pain
amount.21,22, 24,25 Additionally, one study of youth undergoing vaccine injections showed
that interventions to reduce pain and distress (distraction, topical anesthetic) buffered
against the development of negatively biased recalls. 26 Therefore, we will also examine the
effect of VR distraction, on children's later recall of pain and anxiety.
Finally, considering the lack of optimal pain and anxiety management during burn wound care
and the positive effect of an immersive distraction method such as VR for painful and anxiety
inducing procedures, using VR for burn wound care procedures may show promising results.
Aim of the study
The aim of this within-subject randomized clinical trial is to examine the efficacy of an
immersive distraction (virtual reality) compared to the standard treatment for pain and
anxiety management in children requiring burn wound care (hydrotherapy) sessions.
Hypothesis
The use of VR as an adjunct intervention to current burn care (standard pharmacological
treatment) will provide better pain and anxiety management than standard pharmacological
treatment alone.
Objectives:
1. To determine if VR distraction combined with analgesics is more effective than standard
treatment (analgesics alone) to manage procedural pain of children with burn injuries
during hydrotherapy sessions.
2. To compare if VR distraction combined with analgesics is more effective than standard
pharmacological treatment to manage procedural anxiety of children with burn injuries
during hydrotherapy sessions.
3. To compare if, in children with burn injuries, VR distraction combined with the standard
pharmacological treatment sequence generate less recall of procedural pain and anxiety
than standard pharmacological treatment alone sequence.
4. To compare the occurrence of side effects between VR distraction combined with the
standard pharmacological treatment sequence and standard pharmacological treatment alone
sequence.
5. To compare if, in children with burn injuries, VR distraction combined with the standard
pharmacological treatment sequence requires less rescue medication than standard
pharmacological treatment alone sequence.
6. To compare healthcare professionals' satisfaction levels between VR distraction combined
with pharmacological treatment sequence and standard pharmacological treatment alone
sequence.
7. To compare children's satisfaction levels between VR distraction combined with standard
pharmacological treatment sequence and standard pharmacological treatment alone
sequence.
METHODS
Design
This is a within-subject randomized clinical trial design with randomized sequences. Given
the difficulty of ensuring any blinding conditions with the nature of the experimentation,
and in order to limit the interpersonal variability between participants, each child will
serve as their own control, hence receiving both standard (control) and experimental
treatments (VR) during the same treatment session through a randomized order.
Sample and Settings
Recruitment will be done through convenience sampling upon admission to the surgical-trauma
burn unit at CHU Ste-Justine, Montreal (Qc), Canada. Originally, this study also included a
follow-up with those same patients at the rehabilitation clinic for physiotherapy.
Unfortunately, due to the COVID sanitary crisis, recruiting personnel availability and the
difficulty of movement between units and to clinics, recruitment will be limited to the burn
unit. Using a within-subject design allows the possibility of recruiting a minimum of 20
participants considered as a total of 40 patients since they will act as their own control.
Study Timepoints
Measures of pain with the Verbal Numerical Rating Scale (VNRS 0-10) and anxiety with the
Child Fear Scale (CFS, 0-4) will be taken before the treatment session at (T0), after the
first sequence of the session (T1) and after the second sequence of the session (T2) followed
by a measure of healthcare professionals' level of satisfaction via a questionnaire developed
and pretested by the team. Recall of pain and anxiety will be assessed about a week after the
procedure (T3). Data will also be collected on the occurrence of side effects. Clinical
monitoring will be performed by a research nurse independent from the research team.
Sample Size
Since this is a pilot study there is usually no specific requirements regarding the sample
size. Recruiting 20 patients being their own control will provide a total of 40 patients
which is necessary to achieve 80% power to reject the null hypothesis of equal means when the
population mean difference for pain of 2.0 with a standard deviation of 1.0, a mean
difference for anxiety of 1.0 with a standard deviation of 1.0 and a significance level
(alpha) of 0.05 for both components. This sample size considers an attrition rate of 10%.
Data analysis plan
Comparisons will be conducted within and between subjects for the dependent variables for
repeated measures. The mean difference in pain scores of patients at each time-period will be
compared using a paired t-test or Wilcoxon sign-rank test. Since the use of rescue medication
is a potential indication of a treatment failure, the primary analysis will be supplemented
by an analysis comparing the proportion of patients receiving rescue medication anytime
during the procedure. Interpretation of the primary analyses will be made with reference to
the data regarding rescue medication use. Data collected on dichotomous variables will be
analyzed using a chi-square test and post-hoc analyses if the results are statistically
significant. Statistics will be performed by an independent biostatistician from the URCA
(Applied Clinical Research Unit of CHU Sainte-Justine).
