Use Of Virtual Reality For Pain Control in Dermatological Bedside Procedures
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|ClinicalTrials.gov Identifier: NCT04287491|
Recruitment Status : Withdrawn (Lack of funding)
First Posted : February 27, 2020
Last Update Posted : June 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pain||Other: Oculus Go Virtual Reality System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|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|
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.
- 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.
- 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.
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
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Hadar Lev-Tov, MD||University of Miami|