Virtual Reality MObility for Burn Patients

NCT04538573 | Unknown

• 1 other identifier: MOBILE
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Pain intensity: Verbal Numerical Rating Scale (VNRS)

  Assessed using the Verbal Numerical Rating Scale (VNRS). The NRS is an 11-item scale for pain intensity ranging from 0 to 10; 0=no pain to 10= worst pain ever felt.

  Before the procedure to establish baseline (T0); immediately after the first sequence (T1); immediately after the second sequence (T2)

• Levels of anxiety

  Assessed using the Child Fear Scale (CFS). The CFS is a self-reported measure of anxiety adapted from the Faces Anxiety Scale for specific use in children undergoing painful experiences. It consists of five faces ranging from 0 (no fear/anxiety) through 4 (extremely fearful/anxious). The child is asked to indicate which face shows best how he/she felt during the procedure.

  Before the procedure to establish baseline (T0); immediately after the first sequence (T1); immediately after the second sequence (T2)

Secondary Outcomes (7)

• Mean difference in cognitive, affective and sensory components of pain between groups

  Immediately after the first sequence (T1); immediately after the second sequence (T2)

• Children's satisfaction levels

  Immediately after the second sequence (T2)

• Healthcare professional's satisfaction level

  Immediately after the second sequence (T2)

• Need for rescue medication

  Immediately after the first sequence (T1); immediately after the second sequence (T2)

• Occurrence of adverse events

  Immediately after the first sequence (T1); immediately after the second sequence (T2)

Study Arms (2)

Virtual Reality Distraction

EXPERIMENTAL

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

Device: Virtual Reality Distraction

Standard Treatment

ACTIVE COMPARATOR

Standard treatment during burn treatment, dressing changes and hydrotherapy.

Drug: Standard Treatment

Interventions

Virtual Reality Distraction DEVICE

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.

Virtual Reality Distraction

Standard Treatment DRUG

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.

Standard Treatment

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

St. Justine's Hospital

Montreal, Quebec, H1T 3C5, Canada

RECRUITING

Study Officials

• Sylvie Le May, PhD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvie Le May, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Every patient (20) will be their own control (20+20 = 40). Allocation to either intervention or control will be randomized at first and then switched at the crossover period.

Study Record Dates

• First Submitted: August 30, 2020
• First Posted: September 4, 2020
• Study Start: May 27, 2022
• Primary Completion: August 31, 2023
• Study Completion: May 30, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)