Use Of Virtual Reality For Pain Control in Dermatological Bedside Procedures

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 Overview

• Status: Withdrawn
• Conditions: Pain
• Intervention / Treatment: Other: Oculus Go Virtual Reality System

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Group; This group will receive the virtual reality intervention during out-patient bedside procedures.	Other: Oculus Go Virtual Reality System; The VR system will provide a 3D environment that provides distracting stimulus. Participant will put on the Oculus Go VR system headset 1-2 minutes prior to out-patient bedside procedure up to the completion of procedure which takes typically 3-5 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in average pain as assessed by the visual analog scale (VAS)	VAS has a scoring range from 0 to 10 with 0 being no pain and 10 being the worst possible pain.	Baseline, up to 2 hours
Change in maximum pain level as assessed by VAS	VAS has a scoring range from 0 to 10 with 0 being no pain and 10 being the worst possible pain.	Baseline, up to 2 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Hadar Lev-Tov, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 27, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 12, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 20190653

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No