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

Not Applicable

• Conditions: Procedural Pain; Procedural Anxiety
• Interventions: Other: VR-PAT

• Registration Number: NCT05645224
• Lead Sponsor: Nationwide Children's Hospital

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.

Study Timeline

• Study First Submitted: 2022-11-30
• Study First Submitted QC: 2022-12-08
• Study First Posted: 2022-12-09
• Study Start: 2023-01-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
VR-PAT	VR-PAT	Participant wears the Pico Neo 3 Pro Eye headset and actively plays the VR-PAT game.

Primary Outcome Measures

Name	Time	Method
Change in procedural anxiety	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.
Change in procedural pain	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.

Secondary Outcome Measures

Name	Time	Method
Self-reported VR experience	Immediately following laser procedure in VR-PAT group	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.
Nurse-reported utility	Immediately following laser procedure in VR-PAT group	Binary (Yes/No) questions of whether the nurse found VR-PAT to be helpful and easy to use during the procedure.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States