VR-PAT for Pain and Anxiety Management During Pediatric Dermatologic Laser Procedures

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Feasibility Clinical Trial of Virtual Reality for Pain Management During Repeated Pediatric Laser Procedures

Conditions
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Procedural Anxiety, Procedural Pain

Intervention / Treatment
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* Other: VR-PAT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants will be randomly assigned to either the intervention group (VR-PAT) or the 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR-PAT<br>Participant wears the Pico Neo 3 Pro Eye headset and actively plays the VR-PAT game. | Other: VR-PAT<br>* Virtual Reality Pain Alleviation Therapy (VR-PAT) played on a Pico Neo 3 Pro Eye device<br>|
| No Intervention: Control<br>Participant wears the Pico Neo 3 Pro Eye headset to protect eyes, but it is not turned on. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in procedural pain | 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. | Assessed immediately following each laser procedure | 
| Change in procedural anxiety | Modified Yale Preoperative Anxiety Scale (mYPAS) (observed by researcher), 23.33(min)-100(max), with higher scores denoting higher levels of anxiety. | Assessed at 3 time points (prior to entering procedure room, prior to the procedure, and immediately following the procedure) for each laser procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported VR experience | 0-10 Numerical Rating Scale (NRS) (self-reported - VR-PAT arm only), 0(min)-10(max), with higher score meaning better outcome. Asked for degree of realism, pleasure, and satisfaction with VR. | Immediately following laser procedure in VR-PAT group | 
| Nurse-reported utility | Binary (Yes/No) questions of whether the nurse found VR-PAT to be helpful and easy to use during the procedure. | Immediately following laser procedure in VR-PAT group | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser, Dermatology, Virtual Reality, VR