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Virtual Reality for Burns (VR-MOBILE Trial)

N/A

Recruiting

Led By Sylvie Le May, PhD

Research Sponsored by St. Justine's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of a consenting parent who can understand, read and write either French or English

Between the ages of 6 to 17 years and suffering from a burn injury requiring hydrotherapy, physiotherapy or occupational therapy care

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after the first sequence (t1); immediately after the second sequence (t2)

Awards & highlights

VR-MOBILE Trial Summary

This trial will test whether virtual reality can help burn patients during their painful wound-cleaning procedures.

Who is the study for?

This trial is for children aged 6 to 17 with burn injuries needing special therapy. They must have a parent who can consent in French or English. Kids can't join if they have cognitive issues, epilepsy, face burns that prevent wearing VR headsets, or can't sit at an angle needed for the game.Check my eligibility

What is being tested?

The study tests if Virtual Reality (VR) games during treatment can help manage pain and anxiety better than standard drug care alone in pediatric burn patients. Each child will experience both the VR game and standard care in random order during one session.See study design

What are the potential side effects?

Since this trial involves non-pharmacological intervention (VR), side effects are minimal but may include discomfort from wearing the headset or motion sickness from the VR environment.

VR-MOBILE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My parent or guardian can read and understand English or French and agrees to consent.

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I am between 6 to 17 years old and need therapy for a burn injury.

VR-MOBILE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after the first sequence (t1); immediately after the second sequence (t2)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after the first sequence (t1); immediately after the second sequence (t2)

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after the first sequence (t1); immediately after the second sequence (t2) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Levels of anxiety

Pain intensity: Verbal Numerical Rating Scale (VNRS)

Secondary outcome measures

Children's satisfaction levels

Healthcare professional's satisfaction level

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

+4 more

VR-MOBILE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Virtual Reality DistractionExperimental Treatment1 Intervention

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

Group II: Standard TreatmentActive Control1 Intervention

Standard treatment during burn treatment, dressing changes and hydrotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Virtual Reality Distraction

2016

Completed Phase 3

~740

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Justine's HospitalLead Sponsor

196 Previous Clinical Trials

79,009 Total Patients Enrolled

4 Trials studying Burns

76 Patients Enrolled for Burns

Sylvie Le May, PhDPrincipal InvestigatorSt. Justine's Hospital

13 Previous Clinical Trials

1,481 Total Patients Enrolled

2 Trials studying Burns

18 Patients Enrolled for Burns

Media Library

Virtual Reality Distraction Clinical Trial Eligibility Overview. Trial Name: NCT04538573 — N/A

Burns Research Study Groups: Virtual Reality Distraction, Standard Treatment

Burns Clinical Trial 2023: Virtual Reality Distraction Highlights & Side Effects. Trial Name: NCT04538573 — N/A

Virtual Reality Distraction 2023 Treatment Timeline for Medical Study. Trial Name: NCT04538573 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the intended outcome of this investigation?

"This clinical trial aims to evaluate pain intensity through a Verbal Numerical Rating Scale (VNRS) at three different points: before the procedure (T0), immediately after the first sequence (T1), and immediately after the second sequence (T2). Secondary outcomes include maximal range-of-motion of injured limb(s) using a goniometer, parent's satisfaction level with treatments on a numerical scale from 0 to 10; and children's satisfaction levels also rated on a numerical scale from 0 to 10."

Answered by AI

Is enrollment for this trial still available?

"This clinical trial is searching for 20 participants aged between 6 and 17 that have suffered burns."

Answered by AI

Are there currently any vacancies in this research trial?

"Affirmative. According to clinicaltrials.gov, this trial is currently enrolling participants and has been since May 27th 2022. The most recent update was on June 27th 2022 and the study seeks 20 patients from a single site for enrolment."

Answered by AI

How many participants have signed up for the research thus far?

"Affirmative. According to clinicaltrials.gov, this trial is actively recruiting participants, having been posted on May 27th 2022 and revised most recently on June 27th of the same year. Twenty patients are needed at a single location for participation in this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Virtual Reality MObility for Burn Patients

Sylvie Le May 2022. "Virtual Reality MObility for Burn Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04538573.