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

N/AActive Not RecruitingNCT05645224

Nationwide Children's Hospital40 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Procedural Anxiety Procedural Pain

Interventions

VR-PATOTHER

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

Eligibility

Sex: ALLMin age: 5 YearsMax age: 25 Years

Medical Language ↔ Plain English

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

Locations (1)

Nationwide Children's Hospital

Columbus, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

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

Secondary Outcomes

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.

Time frame: 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.

Time frame: Immediately following laser procedure in VR-PAT group

Data from ClinicalTrials.gov

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