Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Use Of Virtual Reality For Pain Control in Dermatological Bedside Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04287491
Recruitment Status : Withdrawn (Lack of funding)
First Posted : February 27, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Hadar Lev-Tov, 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.

Condition or disease Intervention/treatment Phase
Pain Other: Oculus Go Virtual Reality System Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Use Of Virtual Reality For Pain Control in Dermatological Bedside Procedures
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2022

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.




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Change in heart rate [ Time Frame: Baseline, up to 2 hours ]
    Heart rate will be assessed in beats per minute.

  2. Change in oxygen saturation [ Time Frame: Baseline, up to 2 hours ]
    Oxygen saturation will be assessed as a percentage.

  3. Incidence of intervention related adverse events [ Time Frame: Baseline, up to 2 hours ]
    Intervention related adverse events will be assessed per treating physician discretion.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04287491


Locations
Layout table for location information
United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
Layout table for investigator information
Principal Investigator: Hadar Lev-Tov, MD University of Miami
Layout table for additonal information
Responsible Party: Hadar Lev-Tov, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT04287491    
Other Study ID Numbers: 20190653
First Posted: February 27, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No