Clinical trial NCT05645224: VR-PAT for Pain and Anxiety Management During Pediatric Dermatologic Laser Procedures
Official title: Pilot Feasibility Clinical Trial of Virtual Reality for Pain Management During Repeated Pediatric Laser Procedures
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Procedural Anxiety
Procedural Pain
Keywords: Laser
Dermatology
Virtual Reality
VR
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in procedural pain
timeFrame: Assessed immediately following each laser procedure
measure: Change in procedural anxiety
timeFrame: 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:
measure: Self-reported VR experience
timeFrame: Immediately following laser procedure in VR-PAT group
measure: Nurse-reported utility
timeFrame: Immediately following laser procedure in VR-PAT group
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Henry Xiang, MD, MPH, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References: