Use Of Virtual Reality For Pain Control in Dermatological Bedside Procedures

Pain Clinical Trial

Official title:

Use Of Virtual Reality For Pain Control in Dermatological Bedside Procedures

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04287491
• Other study ID #: 20190653
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: June 2020
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

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