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Behavioural Intervention
VR-PAT for Procedural Pain
Columbus, OH
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 continuously throughout burn dressing changes (60 minutes) for the fnirs study period (up to 5 days)
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
See full description
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed continuously throughout burn dressing changes (60 minutes) for the fnirs study period (up to 5 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed continuously throughout burn dressing changes (60 minutes) for the fnirs study period (up to 5 days)
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
Closest Location:Nationwide Children's Hospital· Columbus, OH
Who is running the clinical trial?
Nationwide Children's HospitalLead Sponsor
353 Previous Clinical Trials
5,228,191 Total Patients Enrolled
Henry Xiang, MD, MPH, PhD, MBAPrincipal InvestigatorNationwide Children's Hospital
2 Previous Clinical Trials
60 Total Patients Enrolled