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Virtual Reality Therapy for Burns (BURN-360 Trial)

N/A

Recruiting

Led By Alan D Rogers, MD

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

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

Must have

Patients who will require inpatient stay for at least two consecutive daily dressing changes

Age ≥ 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed 1) at baseline 2) after 2nd dressing procedure, 3) at discharge, 4) at 3 month follow up visit

Awards & highlights

BURN-360 Trial Summary

This trial will use an immersive Virtual Reality distraction tool to help manage pain during burn injury treatment.

Who is the study for?

This trial is for adults over 18 who are alert, can watch VR videos and answer questions. They must be in the hospital for at least two days of dressing changes after one skin graft surgery for burns but haven't had significant face, neck or scalp burns, resistant bacteria infections, communication issues, severe motion sickness history or need mechanical ventilation or IV sedation.Check my eligibility

What is being tested?

The study tests if immersive Virtual Reality (VR) during dressing changes post-skin graft surgery can reduce pain and anxiety. This could potentially lower the need for opioid painkillers. Participants will use VR headgear to view 360 videos created by researchers and rate their pain and anxiety before and after.See study design

What are the potential side effects?

While not a medication with direct side effects, using VR may cause discomfort like dizziness or nausea especially in those prone to motion sickness. The study excludes individuals with a history of significant motion sickness to minimize this risk.

BURN-360 Trial Eligibility Criteria

Inclusion Criteria

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

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I will need to stay in the hospital for at least two days for dressing changes.

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I am 18 years old or older.

BURN-360 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 dressing changes: day 1 and day 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 dressing changes: day 1 and day 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 dressing changes: day 1 and day 2 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in opioid consumption between the first two dressing changes

Cumulative opioid analgesia consumption

Secondary outcome measures

Additive effect of VR exposure on pain

Anxiety assessment

Dressing change efficiency

+5 more

BURN-360 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: VR-360 group (VR-group)Experimental Treatment1 Intervention

Patients will watch a VR-360 distraction video during dressing change. The patient will be asked or helped to wear the HMD write in full at the onset of a procedure and watch the VR-360 video during the dressing change procedure. When experiencing pain, the patient may indicate the need for further analgesic medication during the procedure, the patient will be asked to push a button in their hand that will trigger a light-based signal for the nurse to provide further analgesic medication. Should their hands both be involved in the burn injury, the patient will indicate the same verbally.

Group II: Control Group (standard treatment)Active Control1 Intervention

The patients will receive standard treatment and will be instructed to use the same button to indicate their pain.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

657 Previous Clinical Trials

1,551,231 Total Patients Enrolled

5 Trials studying Burns

406 Patients Enrolled for Burns

Alan D Rogers, MDPrincipal InvestigatorSHSC

Media Library

Immersive VR Video Clinical Trial Eligibility Overview. Trial Name: NCT04820400 — N/A

Burns Research Study Groups: VR-360 group (VR-group), Control Group (standard treatment)

Burns Clinical Trial 2023: Immersive VR Video Highlights & Side Effects. Trial Name: NCT04820400 — N/A

Immersive VR Video 2023 Treatment Timeline for Medical Study. Trial Name: NCT04820400 — N/A

Frequently Asked Questions

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

Are there any remaining positions in this clinical trial open to participants?

"Affirmative. As per the information on clinicaltrials.gov, this research initiative is actively recruiting participants as of May 4th 2022 - an update from its initial posting date of March 24 2021. The overall recruitment target for this trial stands at 80 individuals across a single site."

Answered by AI

What is the estimated sample size of this clinical experiment?

"Right, clinicaltrials.gov affirms that this research project is actively seeking participants. It was launched on March 24th 2021 and updated last on May 4th 2022. Currently, 80 individuals need to be registered from 1 centre."

Answered by AI

What is the expected result of this trial?

"This trial has one main goal; to measure cumulative opioid analgesia consumption during the peri-procedural period (starting 4 hours before, and finishing after a four hour dressing change). Additionally, it seeks to evaluate the additive effect of virtual reality exposure on pain by calculating dose differences between two consecutive dressings. Participants will also be asked rate their anxiety using the Visual Analogue Scale for Anxiety (VASa) and rate their pain with Numeric Rating Scale for Pain (NRS); both are 0-10 scales where zero is no discomfort and 10 is unbearable suffering."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reducing Pain and Anxiety During Dressing Changes After Burn Surgery Using Virtual Reality

2021. "Reducing Pain and Anxiety During Dressing Changes After Burn Surgery Using Virtual Reality". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04820400.