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

• Sponsor: Nationwide Children's Hospital (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05645224
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23.7
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Procedural Anxiety; Procedural Pain	Other: VR-PAT	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• 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.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.
• Masking: Single (Investigator)
• Masking Description: Researcher conducting the post-procedural survey is blinded to the group assignment
• Primary Purpose: Supportive Care
• Official Title: Pilot Feasibility Clinical Trial of Virtual Reality for Pain Management During Repeated Pediatric Laser Procedures
• Actual Study Start Date: Jan 9, 2023
• Anticipated Primary Completion Date: Dec 30, 2024
• Anticipated Study Completion Date: Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VR-PAT Participant wears the Pico Neo 3 Pro Eye headset and actively plays the VR-PAT game.	Other: VR-PAT; Virtual Reality Pain Alleviation Therapy (VR-PAT) played on a Pico Neo 3 Pro Eye device
No Intervention: Control Participant wears the Pico Neo 3 Pro Eye headset to protect eyes, but it is not turned on.

Outcome Measures

Primary Outcome Measures

1. Change in procedural pain [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 [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 Outcome Measures

1. Self-reported VR experience [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nationwide Children's Hospital	Columbus	Ohio	United States	43205

Sponsors and Collaborators

• Nationwide Children's Hospital

Investigators

• Principal Investigator: Henry Xiang, MD, MPH, PhD, MBA, Nationwide Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Henry Xiang, Professor of Medicine and Center Director, Nationwide Children's Hospital
• ClinicalTrials.gov Identifier: NCT05645224
• Other Study ID Numbers: STUDY00002880
• First Posted: Dec 9, 2022
• Last Update Posted: Jan 31, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Henry Xiang, Professor of Medicine and Center Director, Nationwide Children's Hospital: Laser; Dermatology; Virtual Reality; VR
• Additional relevant MeSH terms: Pain, Procedural

Study Results

No Results Posted as of Jan 31, 2023