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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Recruitment Status : Withdrawn (Lack of funding)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

Tracking Information
First Submitted Date  ICMJE February 25, 2020
First Posted Date  ICMJE February 27, 2020
Last Update Posted Date June 16, 2020
Estimated Study Start Date  ICMJE January 1, 2021
Estimated Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2020)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2020)
  • Change in heart rate [ Time Frame: Baseline, up to 2 hours ]
    Heart rate will be assessed in beats per minute.
  • Change in oxygen saturation [ Time Frame: Baseline, up to 2 hours ]
    Oxygen saturation will be assessed as a percentage.
  • Incidence of intervention related adverse events [ Time Frame: Baseline, up to 2 hours ]
    Intervention related adverse events will be assessed per treating physician discretion.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use Of Virtual Reality For Pain Control in Dermatological Bedside Procedures
Official Title  ICMJE Use Of Virtual Reality For Pain Control in Dermatological Bedside Procedures
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Pain
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Virtual Reality Group
This group will receive the virtual reality intervention during out-patient bedside procedures.
Intervention: Other: Oculus Go Virtual Reality System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 12, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2020)
30
Estimated Study Completion Date  ICMJE April 1, 2022
Estimated Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04287491
Other Study ID Numbers  ICMJE 20190653
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hadar Lev-Tov, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hadar Lev-Tov, MD University of Miami
PRS Account University of Miami
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP