Recruiting

Virtual Reality

Sponsor:

St. Justine's Hospital

Code:

NCT04538573

Conditions

Pediatric Burns

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Virtual Reality Distraction

Standard Treatment

Study Details

Brief 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.

Conditions

Pediatric Burns

Study ID

NCT04538573

Start date

May 27, 2022

Status verified date

Nov, 2023

Completion date

May 30, 2024

Anticipated

Primary completion date

Aug 31, 2023

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Between the ages of 6 to 17 years and suffering from a burn injury requiring hydrotherapy, physiotherapy or occupational therapy care
  • Presence of a consenting parent who can understand, read and write either French or English.

Exclusion Criteria:

  • Have a diagnosed cognitive impairment precluding them from playing a virtual reality game
  • Suffer from epilepsy considering the nature of the intervention
  • Have burn injuries on the face preventing the use of the Oculus Quest Helmet
  • Cannot be in a sitting or semi-upright sitting position (semi-Fowler's position) during the procedure as the virtual reality game requires an angle of at least 30 degrees for head-tracking. Participants who received analgesics (e.g. acetaminophen, ibuprofen) or anxiolytics (e.g. benzodiazepines) during the last 4 hours prior to the procedure will not be excluded but the name of medication, dosage and time of administration will be documented in the data collection form.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Virtual Reality Distraction

Use of virtual reality (VR) during during burn treatment, dressing changes and hydrotherapy.

active comparator: Standard Treatment

Standard treatment during burn treatment, dressing changes and hydrotherapy.

Interventions

Virtual Reality Distraction

Patients in this group will be offered to use Oculus Rift goggles while undergoing the burn treatments, dressing changes and hydrotherapy to reduce pain and anxiety during treatment. The goggles will display Dreamland, a virtual reality videogame created by our team to maximize fun, diminish difficulty, and motion sickness. The system will be available 5 minutes before treatment to the patient in order to ease acclimatation to the goggles until the end of the treatment session.

Standard Treatment

Standard pharmacological care as per the unit's protocol will serve as the control for half of the duration of every treatment session. It consists of different analgesic and sedative medication used in combination in order to help patients go through the procedure. The unit's protocol includes drugs such as Morphine, Hydromorphone, Fentanyl, Clonidine, Ketamine, Midazolam and Acetaminophen.

Use of any co-interventions for pain or anxiety management (music, comforting, child life specialist or other) during this sequence will be documented.

Primary outcome measure

  • Pain intensity: Verbal Numerical Rating Scale (VNRS) [ Time Frame: Before the procedure to establish baseline (T0); immediately after the first sequence (T1); immediately after the second sequence (T2) ]
  • Levels of anxiety [ Time Frame: Before the procedure to establish baseline (T0); immediately after the first sequence (T1); immediately after the second sequence (T2) ]

Central Contacts and Locations

Central contacts

Sylvie Le May, PhD

514-345-4931sylvie.lemay@umontreal.ca

Locations

St. Justine's Hospital

Recruiting

Montréal, Quebec, Canada, H1T 3C5

Contacts

Sylvie Le May, PhD

514-345-4931sylvie.lemay@umontreal.ca

Principal Investigator:

Sylvie Le May, PhD

More Information

Sponsor

St. Justine's Hospital

Last update posted

Nov 18, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Justine's Hospital on 2023-11-18.