BurnsNCT02986464
Virtual Reality Distraction for Procedural Pain Management in Children With Burn Injuries: a Randomized Controlled Trial
A study testing Virtual Reality Prototype and Standard Pharmacological Treatment in people with Burns and Child, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
Procedural pain is the most intense and often undertreated pain associated with burn injuries. The use of analgesics does not always provide optimal relief and is accompanied by several side effects. Read more about this study
- Who is it for?
- Ages 6 months to 7 years
- What is being tested?
- Virtual Reality Prototype and Standard Pharmacological Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- 3 May 2018to 14 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- suffer from a burn injury requiring a hydrotherapy session
- presence of a consenting parent who can understand, read and write either French or English
Who cannot join
- Requiring intensive care
- Having a diagnosed cognitive impairment
- Are unconscious or intubated during the hydrotherapy sessions
- Suffering from epilepsy (considering the nature of the intervention)
- Allergic to opioids or other analgesics used for standard pharmacological treatment
- Having burn injuries on the face preventing them from looking at the VR screen
- Will be excluded in posteriori from analysis children sedated for more than 50% of the time during one or both study sequences (score of 3 or 4 on the University of Michigan Sedation Scale).
Trial locations and contacts
1 site in 1 country.
About this study
Procedural pain is the most intense and often undertreated pain associated with burn injuries. The use of analgesics does not always provide optimal relief and is accompanied by several side effects. Indeed, children with burn injuries still experience severe pain intensity during procedures despite the fact that doses of analgesics used with this population has almost doubled in the last twenty years. Current guidelines on pediatric procedural pain management recommend the combination of non-pharmacological and pharmacological interventions to enhance pain management and decrease the numerous side effects of analgesics. Distraction has been identified among the most effective non-pharmacological interventions for pain as it diverts the child's attention to an attractive element, hindering the perception of the painful stimuli. Virtual reality is a method of active distraction that offers the child a multi-sensory immersive interaction that found many applications for pain management in adult patients. However, very few studies have tested the efficacy of distraction by virtual reality on procedural pain and anxiety in children with burn injuries.
This RCT follows a pilot study (NCT02794103) aimed at assessing the feasibility of a virtual reality prototype developed specifically for the hydrotherapy room of children under seven years old for the relief of procedural pain in children with burn injuries. The aim of the RCT will be to evaluate the effectiveness of the virtual reality prototype in relieving procedural pain in children from 6 months to 7 years old undergoing hydrotherapy session for burn injuries.
Read the detailed description
BACKGROUND:
Preliminary data from the pilot study showed that the virtual reality prototype installed around the tank in the hydrotherapy room is a feasible and acceptable method of distraction that doesn't interfere with the work of healthcare professionals and could be used as a non-pharmacological method for pain management. A clinical trial is needed to assess the effectiveness of this intervention for procedural pain relief. The pilot study was also informative about the feasibility of the study design and the measurement used. The methods section was modified and adapted consequently for the upcoming trial.
METHODS:
Design: Within-subject/crossover study design. Each child will serve as their own control and will receive both standard and experimental treatment during the same hydrotherapy session through a randomized order.
Sample and Setting: Convenience sampling on the surgical-trauma burn unit at CHU Ste-Justine, of children admitted to the unit or to the day hospital for a burn injury. The intervention will take place in the hydrotherapy room of the CHU Ste-Justine.
Interventions. A) Standard pharmacological treatment as per the unit's protocol. B) VR distraction through the use of a virtual reality prototype installed around the tank in the hydrotherapy room. The prototype has been developed in collaboration with the Society of Arts and Technology (SAT) in Montreal to provide an immersive interactive experience for the burn child in the hydrotherapy tank. The prototype was developed after several meetings between the researchers, the designers and engineers and the surgical trauma team of CHU Ste-Justine. Meetings were followed by an ergonomic study of the hydrotherapy room to meet the unit's and patients' specifications and ensure that it doesn't interfere with the healthcare professionals work.The video games were developed by our team with a personalized care content tailored to the children's developmental stage and to maximize the feeling of immersion and minimize cybersickness, and approved by a team of healthcare professionals in pediatric burn care.
Study proceedings: Hydrotherapy sessions typically last between 20 to 40 minutes. The duration will be divided into two sequences of the same duration (10 to 20 minutes) where the participant receives the same care by the same healthcare professional. For one sequence, only the standard treatment will be administered and for the other sequence, patients will receive the standard treatment in addition to Virtual Reality via the screen around the tank in a randomized order.
Measures: Pain and anxiety measures will be taken before the treatment session at Baseline (T1), in the middle of the first sequence of the session (T2) and in the middle of the second sequence of the session (T3) followed by a measure of healthcare professionals' satisfaction level via a questionnaire developed and pretested by the team after the session (T4). Data will be collected on the average doses of analgesics administered before and during the session, and the side effects experienced.
Data analysis: Quantitative analysis. Mean differences in pain scores between sequences will be compared using Wilcoxon test.
- Being tested
- Virtual Reality Prototype, Standard Pharmacological Treatment
- Keywords
- Virtual reality, Immersive distraction, Virtual world, Virtual environment, Procedural pain, Acute pain, Pain Management, Children, Child, Kid, Kids, Pediatric, Pediatrics, Young children, Burns, Burn injuries, Burn unit, Hydrotherapy, Burn dressing, Non-pharmacological, Clinical Research, Nursing Practice
- Medical subject headings
- Burns, Pain, Pain, Procedural, Acute Pain, Agnosia, Deafness, Autosomal Recessive 1A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality PrototypeDevice
VR prototype installed around the tank in the hydrotherapy room to give the child a sense of immersion in the virtual world with a possibility of interaction depending on the child's age and condition.
Standard Pharmacological TreatmentOther
According to the unit's protocol and adjusted to each participant's age, weight and condition by the anesthetist and the pain clinic nurse.
| Study group | Role | What they receive |
|---|---|---|
| Standard pharmacological treatment | Active comparator | Not described Receives: Other: Standard Pharmacological Treatment |
| Virtual Reality distraction | Experimental | Not described Receives: Device: Virtual Reality Prototype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Pain Score
French version of the Face, Legs, Activity, Cry and Consolability (FLACC)
Measured: T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
Secondary outcomes (5)
Mean Pain Score - Observational/Behavioral Complementary measure
Visual Analog Scale by proxy
Measured: T1: baseline; T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
Comfort
Behavioural observation scale of comfort level for child burn victims (OCCEB- BECCO)
Measured: T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
Sedation
University of Michigan Sedation Scale (UMSS)
Measured: T1: baseline; T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
Health professionals' satisfaction level
Pre-tested tailored questionnaire including tolerance, positive and negative aspects
Measured: T4: immediately after the procedure before leaving the hydrotherapy room
Analgesic requirement
Rescue dose medication administration
Measured: T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study start3 May 2018
- Primary completion14 Jun 2019
- Study completion14 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sylvie Le May, St. Justine's Hospital
- Investigators
- Christelle Khadra, RN, PhD (c), Principal investigator, Université de Montreal; CHU Ste-Justine Research CenterSylvie Le May, RN, PhD, Study director, Université de Montreal; CHU Ste-Justine Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986464
- Sponsor's protocol ID
- 2017-1382
- Status last verified
- Jul 2019
- First submitted
- 6 Dec 2016
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khadra C, Ballard A, Paquin D, Cotes-Turpin C, Hoffman HG, Perreault I, Fortin JS, Bouchard S, Theroux J, Le May S. Effects of a projector-based hybrid virtual reality on pain in young children with burn injuries during hydrotherapy sessions: A within-subject randomized crossover trial. Burns. 2020 Nov;46(7):1571-1584. doi: 10.1016/j.burns.2020.04.006. Epub 2020 May 7.
PubMed 32389349
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Distraction for Procedural Pain Management in Children With Burn Injuries: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02986464
- Acronym / sponsor ID
- 2017-1382
- Keywords
- Virtual reality, Immersive distraction, Virtual world, Virtual environment, Procedural pain, Acute pain, Pain Management, Children, Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- 3 May 2018 (actual)
- Primary completion
- 14 Jun 2019 (actual)
- Study completion
- 14 Jun 2019 (actual)
- First posted
- 8 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Procedural pain is the most intense and often undertreated pain associated with burn injuries. The use of analgesics does not always provide optimal relief and is accompanied by several side effects. Indeed, children with burn injuries still experience severe pain intensity during procedures despite the fact that doses of analgesics used with this population has almost doubled in the last twenty years. Current guidelines on pediatric procedural pain management recommend the combination of non-pharmacological and pharmacological interventions to enhance pain management and decrease the numerous side effects of analgesics. Distraction has been identified among the most effective non-pharmacological interventions for pain as it diverts the child's attention to an attractive element, hindering the perception of the painful stimuli. Virtual reality is a method of active distraction that offers the child a multi-sensory immersive interaction that found many applications for pain management in adult patients. However, very few studies have tested the efficacy of distraction by virtual reality on procedural pain and anxiety in children with burn injuries.
This RCT follows a pilot study (NCT02794103) aimed at assessing the feasibility of a virtual reality prototype developed specifically for the hydrotherapy room of children under seven years old for the relief of procedural pain in children with burn injuries. The aim of the RCT will be to evaluate the effectiveness of the virtual reality prototype in relieving procedural pain in children from 6 months to 7 years old undergoing hydrotherapy session for burn injuries.
Detailed description
BACKGROUND:
Preliminary data from the pilot study showed that the virtual reality prototype installed around the tank in the hydrotherapy room is a feasible and acceptable method of distraction that doesn't interfere with the work of healthcare professionals and could be used as a non-pharmacological method for pain management. A clinical trial is needed to assess the effectiveness of this intervention for procedural pain relief. The pilot study was also informative about the feasibility of the study design and the measurement used. The methods section was modified and adapted consequently for the upcoming trial.
METHODS:
Design: Within-subject/crossover study design. Each child will serve as their own control and will receive both standard and experimental treatment during the same hydrotherapy session through a randomized order.
Sample and Setting: Convenience sampling on the surgical-trauma burn unit at CHU Ste-Justine, of children admitted to the unit or to the day hospital for a burn injury. The intervention will take place in the hydrotherapy room of the CHU Ste-Justine.
Interventions. A) Standard pharmacological treatment as per the unit's protocol. B) VR distraction through the use of a virtual reality prototype installed around the tank in the hydrotherapy room. The prototype has been developed in collaboration with the Society of Arts and Technology (SAT) in Montreal to provide an immersive interactive experience for the burn child in the hydrotherapy tank. The prototype was developed after several meetings between the researchers, the designers and engineers and the surgical trauma team of CHU Ste-Justine. Meetings were followed by an ergonomic study of the hydrotherapy room to meet the unit's and patients' specifications and ensure that it doesn't interfere with the healthcare professionals work.The video games were developed by our team with a personalized care content tailored to the children's developmental stage and to maximize the feeling of immersion and minimize cybersickness, and approved by a team of healthcare professionals in pediatric burn care.
Study proceedings: Hydrotherapy sessions typically last between 20 to 40 minutes. The duration will be divided into two sequences of the same duration (10 to 20 minutes) where the participant receives the same care by the same healthcare professional. For one sequence, only the standard treatment will be administered and for the other sequence, patients will receive the standard treatment in addition to Virtual Reality via the screen around the tank in a randomized order.
Measures: Pain and anxiety measures will be taken before the treatment session at Baseline (T1), in the middle of the first sequence of the session (T2) and in the middle of the second sequence of the session (T3) followed by a measure of healthcare professionals' satisfaction level via a questionnaire developed and pretested by the team after the session (T4). Data will be collected on the average doses of analgesics administered before and during the session, and the side effects experienced.
Data analysis: Quantitative analysis. Mean differences in pain scores between sequences will be compared using Wilcoxon test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard pharmacological treatment | Active comparator | Other: Standard Pharmacological Treatment |
| Virtual Reality distraction | Experimental | Device: Virtual Reality Prototype |
Who may qualify
- Ages
- 6 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- suffer from a burn injury requiring a hydrotherapy session
- presence of a consenting parent who can understand, read and write either French or English
Key exclusion criteria (7 listed)
- Requiring intensive care
- Having a diagnosed cognitive impairment
- Are unconscious or intubated during the hydrotherapy sessions
- Suffering from epilepsy (considering the nature of the intervention)
- Allergic to opioids or other analgesics used for standard pharmacological treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality PrototypeVR prototype installed around the tank in the hydrotherapy room to give the child a sense of immersion in the virtual world with a possibility of interaction depending on the child's age and condition. | Device | Virtual Reality distraction |
| Standard Pharmacological TreatmentAccording to the unit's protocol and adjusted to each participant's age, weight and condition by the anesthetist and the pain clinic nurse. | Other | Standard pharmacological treatment |
Primary outcome
Mean Pain Score
Time frame: T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
French version of the Face, Legs, Activity, Cry and Consolability (FLACC)
5 secondary outcomes
Mean Pain Score - Observational/Behavioral Complementary measure
Time frame: T1: baseline; T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
Comfort
Time frame: T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
Sedation
Time frame: T1: baseline; T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
Health professionals' satisfaction level
Time frame: T4: immediately after the procedure before leaving the hydrotherapy room
Analgesic requirement
Time frame: T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Derived from this study: PubMed 32389349Khadra C, Ballard A, Paquin D, Cotes-Turpin C, Hoffman HG, Perreault I, Fortin JS, Bouchard S, Theroux J, Le May S. Effects of a projector-based hybrid virtual reality on pain in young children with burn injuries during hydrotherapy sessions: A within-subject randomized crossover trial. Burns. 2020 Nov;46(7):1571-1584. doi: 10.1016/j.burns.2020.04.006. Epub 2020 May 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christelle Khadra, RN, PhD (c) principal investigator
Université de Montreal; CHU Ste-Justine Research Center
Sylvie Le May, RN, PhD study director
Université de Montreal; CHU Ste-Justine Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Prototype and Standard Pharmacological Treatment in people with Burns and Child, run by St. Justine's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Pain Score (time frame: T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02986464, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019; AzTrials last refreshed its copy on 7 Nov 2026.