Pilot Feasibility Clinical Trial of Virtual Reality for Pain Management During Repeated Pediatric Laser Procedures
Overview
- Phase
- N/A
- Intervention
- VR-PAT
- Conditions
- Procedural Anxiety
- Sponsor
- Nationwide Children's Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in procedural pain
- Status
- Active, Not Recruiting
- Last Updated
- last month
Overview
Brief Summary
This study will assess the feasibility and efficacy of our Virtual Reality Pain Alleviation Therapy (VR-PAT) for pain management during pediatric and young adult outpatient laser procedures and evaluate the impact of VR use on reducing anxiety in patients undergoing dermatologic laser procedures. The investigators hypothesize that patients using VR-PAT will report less pain and anxiety during the laser procedure than patients who do not play the game.
Detailed Description
In this two-group crossover randomized clinical trial, patients will be randomly assigned to either the VR-PAT intervention group or control group (same VR google without game) at the first laser procedure and will then cross-over to the alternative group for the second laser procedure. Survey questions to assess pain and anxiety and control for confounding factors will be asked before and after each procedure.
Investigators
Henry Xiang
Professor of Medicine and Center Director
Nationwide Children's Hospital
Eligibility Criteria
Inclusion Criteria
- •dermatology patients (5+ years) who are undergoing first laser procedure at the Nationwide Children's Outpatient Laser
- •have a legal guardian present for patients less than 18 years old for the procedure (for informed consent)
- •can communicate orally
Exclusion Criteria
- •any wounds that may interfere with study procedures
- •usage of a diode laser (VR safety has not been established yet)
- •vision, hearing, or cognitive/motor impairments preventing valid administration of study measures
- •history of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras
- •minors in foster care
- •unable to communicate in English
- •pregnant women
- •prisoners
Arms & Interventions
VR-PAT
Participant wears the Pico Neo 3 Pro Eye headset and actively plays the VR-PAT game.
Intervention: VR-PAT
Control
Participant wears the Pico Neo 3 Pro Eye headset to protect eyes, but it is not turned on.
Outcomes
Primary Outcomes
Change in procedural pain
Time Frame: Assessed immediately following each laser procedure
0-10 Numerical Rating Scale (NRS) (self-reported and caregiver-reported (if \<18 years)), 0(min)-10(max), with higher score indicating worse pain. Asked for worst pain, average pain, and time spent thinking about pain.
Change in procedural anxiety
Time Frame: Assessed at 3 time points (prior to entering procedure room, prior to the procedure, and immediately following the procedure) for each laser procedure
Modified Yale Preoperative Anxiety Scale (mYPAS) (observed by researcher), 23.33(min)-100(max), with higher scores denoting higher levels of anxiety.
Secondary Outcomes
- Self-reported VR experience(Immediately following laser procedure in VR-PAT group)
- Nurse-reported utility(Immediately following laser procedure in VR-PAT group)