Use Of Virtual Reality For Pain Control in Dermatological Bedside Procedures

Not Applicable

Withdrawn

• Conditions: Pain
• Interventions: Other: Oculus Go Virtual Reality System

• Registration Number: NCT04287491
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-02-25
• Study First Posted: 2020-02-27
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-12
• Last Update Posted: 2020-06-16
• Study Start: 2021-01-01
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual Reality Group	Oculus Go Virtual Reality System	This group will receive the virtual reality intervention during out-patient bedside procedures.

Primary Outcome Measures

Name	Time	Method
Change in average pain as assessed by the visual analog scale (VAS)	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	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 Outcome Measures

Name	Time	Method
Change in oxygen saturation	Baseline, up to 2 hours	Oxygen saturation will be assessed as a percentage.
Incidence of intervention related adverse events	Baseline, up to 2 hours	Intervention related adverse events will be assessed per treating physician discretion.
Change in heart rate	Baseline, up to 2 hours	Heart rate will be assessed in beats per minute.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States