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

Procedural Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05645224
• Other study ID #: STUDY00002880
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 9, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Procedural
• Procedural Anxiety
• Procedural Pain

Intervention

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

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Assessed immediately following each laser procedure
Primary	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.	Assessed at 3 time points (prior to entering procedure room, prior to the procedure, and immediately following the procedure) for each laser procedure
Secondary	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.	Immediately following laser procedure in VR-PAT group
Secondary	Nurse-reported utility	Binary (Yes/No) questions of whether the nurse found VR-PAT to be helpful and easy to use during the procedure.	Immediately following laser procedure in VR-PAT group