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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05645224
Other study ID # STUDY00002880
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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