Use Of Virtual Reality For Pain Control in Dermatological Bedside Procedures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of Miami
- Locations
- 1
- Primary Endpoint
- Change in average pain as assessed by the visual analog scale (VAS)
Study Overview
Brief Summary
The purpose of this research study is to explore the impact of virtual reality (VR) on pain perception during out-patient procedures such as wart removal, wound debridement, and lidocaine injections.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 13 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients 13 years and older.
- •Patient (or health care proxy when applicable) must sign an ICF.
- •Patient requiring any painful dermatological bedside procedure including: wound debridement, injections and liquid nitrogen application.
- •Patients willing to participate and parents able to consent.
Exclusion Criteria
- •Subjects with a diagnosis of vertigo, inner ear diseases or seizures are excluded due to the uncertainty of performance under VR conditions.
- •Subjects requiring procedures on the head are also excluded to the interference of the VR headset.
Arms & Interventions
Virtual Reality Group
This group will receive the virtual reality intervention during out-patient bedside procedures.
Intervention: Oculus Go Virtual Reality System (Other)
Outcomes
Primary Outcomes
Change in average pain as assessed by the visual analog scale (VAS)
Time Frame: Baseline, up to 2 hours
VAS has a scoring range from 0 to 10 with 0 being no pain and 10 being the worst possible pain.
Change in maximum pain level as assessed by VAS
Time Frame: Baseline, up to 2 hours
VAS has a scoring range from 0 to 10 with 0 being no pain and 10 being the worst possible pain.
Secondary Outcomes
- Change in oxygen saturation(Baseline, up to 2 hours)
- Incidence of intervention related adverse events(Baseline, up to 2 hours)
- Change in heart rate(Baseline, up to 2 hours)
Investigators
Hadar Lev-Tov
Professor
University of Miami