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Behavioural Intervention

VR-PAT for Procedural Pain

N/A
Waitlist Available
Led By Henry Xiang, MD, MPH, PhD, MBA
Research Sponsored by Nationwide Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at 3 time points (30 minutes prior to procedure, immediately prior to procedure, and within 15 minutes immediately following the procedure) for each dressing change
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to use a special kind of scan called functional near-infrared spectroscopy (fNIRS) to find and measure pain signals when patients with burns are having their dressings changed. They

Who is the study for?
This trial is for children aged 6-17 with acute burn injuries being treated at NCH burn unit, who need daily dressing changes over three days. Participants must be able to communicate in English. It's not suitable for those with motion sickness, seizures, dizziness from visual auras, or cognitive impairments that prevent study participation.
What is being tested?
The study tests how well virtual reality (VR) can help manage pain during burn dressing changes by using functional near-infrared spectroscopy (fNIRS) to track brain signals and identify pain biomarkers.
What are the potential side effects?
Since the intervention involves VR technology, potential side effects may include temporary discomfort like nausea or dizziness due to motion sickness but are generally minimal as no drugs or invasive procedures are involved.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at 3 time points (30 minutes prior to procedure, immediately prior to procedure, and within 15 minutes immediately following the procedure) for each dressing change
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at 3 time points (30 minutes prior to procedure, immediately prior to procedure, and within 15 minutes immediately following the procedure) for each dressing change for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in brain activity
Secondary study objectives
Change in procedural anxiety
Procedural pain during burn dressing changes
Self-reported VR experience

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: VR-PATExperimental Treatment1 Intervention
Participant wears the Pico Neo 3 Pro Eye headset and actively plays the VR-PAT game while also wearing the fNIRS, during their clinically scheduled burn dressing change.
Group II: ControlActive Control1 Intervention
Participant wears the fNIRS and can engage in standard distraction techniques, during their clinically scheduled burn dressing change.

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor
348 Previous Clinical Trials
5,228,065 Total Patients Enrolled
7 Trials studying Burns
2,174 Patients Enrolled for Burns
Henry Xiang, MD, MPH, PhD, MBAPrincipal InvestigatorNationwide Children's Hospital
1 Previous Clinical Trials
40 Total Patients Enrolled
~3 spots leftby Dec 2025
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