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NCT Number: NCT05645224

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Procedural Anxiety Neurologic Manifestations Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Procedural Pain Signs and Symptoms

Age range

5 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VR-PAT

Other

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

Primary outcomes

  1. 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.

  2. 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

  1. Self-reported VR experience

    Time frame: 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.

  2. Nurse-reported utility

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Dec 9, 2022
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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