Study Stopped
Lack of funding
Use Of Virtual Reality For Pain Control in Dermatological Bedside Procedures
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2021
Typical duration for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2020
CompletedFirst Posted
Study publicly available on registry
February 27, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedJune 16, 2020
June 1, 2020
1.2 years
February 25, 2020
June 12, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Change in heart rate
Baseline, up to 2 hours
Change in oxygen saturation
Baseline, up to 2 hours
Incidence of intervention related adverse events
Baseline, up to 2 hours
Study Arms (1)
Virtual Reality Group
EXPERIMENTALThis group will receive the virtual reality intervention during out-patient bedside procedures.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hadar Lev-Tov, MD
University of Miami
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 25, 2020
First Posted
February 27, 2020
Study Start
January 1, 2021
Primary Completion
April 1, 2022
Study Completion
April 1, 2022
Last Updated
June 16, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share