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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-09

Study Completion Date

2026-01-31

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.

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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.

Conditions

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Procedural Anxiety Procedural Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Researcher conducting the post-procedural survey is blinded to the group assignment

Study Groups

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VR-PAT

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

Group Type EXPERIMENTAL

VR-PAT

Intervention Type OTHER

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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VR-PAT

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

Intervention Type OTHER

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

Minimum Eligible Age

5 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No