Virtual Reality MObility for Burn Patients

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

Interventions

DEVICE

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.

DRUG

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.

Sponsors & Collaborators

• St. Justine's Hospital

  lead OTHER

Principal Investigators

• Sylvie Le May, PhD · St. Justine's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

6 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-27

Primary Completion

2023-08-31

Completion

2024-05-30

Countries

• Canada

Study Locations