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

NCT05645224 | Active Not Recruiting

• 1 other identifier: STUDY00002880
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Anxiety; Procedural Pain

Keywords

Laser; Dermatology; Virtual Reality; VR

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Self-reported VR experience

  Immediately following laser procedure in VR-PAT group

• Nurse-reported utility

  Immediately following laser procedure in VR-PAT group

Study Arms (2)

VR-PAT

EXPERIMENTAL

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

Other: VR-PAT

Control

NO INTERVENTION

Participant wears the Pico Neo 3 Pro Eye headset to protect eyes, but it is not turned on.

Interventions

VR-PAT OTHER

Virtual Reality Pain Alleviation Therapy (VR-PAT) played on a Pico Neo 3 Pro Eye device

VR-PAT

Eligibility Criteria

• Age: 5 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Henry Xiang, MD, MPH, PhD, MBA

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Researcher conducting the post-procedural survey is blinded to the group assignment
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Center Director

Model Details: 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.

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 9, 2022
• Study Start: January 9, 2023
• Primary Completion: November 14, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)