- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04893278
Virtual Reality in Electrophysiology Laboratory (EP)
March 12, 2024 updated by: Klaus D. Torp, Mayo Clinic
Use of Virtual Reality as An Adjunct for Anesthesia During Procedures in the Electrophysiology Laboratory: A Pilot and Feasibility Study
The purpose of this study is to evaluate the use of virtual reality (VR) technology as adjunct to routine anesthesia care for patients undergoing electrophysiology (EP) procedures.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32224
- Mayo Clinic in Florida
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Subjects will be selected from patients undergoing procedures under monitored anesthesia care.
Description
Inclusion Criteria:
- Age ≥ 18 years old.
- Patients scheduled for electrophysiology procedure with MAC.
- Subject willing to participate and able to provide informed consent.
Exclusion Criteria:
- Age < 18 years old.
- History of motion sickness or blindness.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Virtual reality
|
Use of Virtual reality goggles during procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Virtual reality as distractor
Time Frame: Up to 2hours
|
Evaluate patients' experience and satisfaction with using virutal reality during electrophysiology procedures
|
Up to 2hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of virtual reality use on pharmacological therapy
Time Frame: Up to 2 hours
|
Evalute the amount of medications use during the procedure
|
Up to 2 hours
|
Impact of virtual reality on electrophysilogy procedure
Time Frame: Up to 2 hours
|
Evaluate success rate of completing ablation while patient is utilizing virtual reality
|
Up to 2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Klaus Torp, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 31, 2021
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
May 14, 2021
First Submitted That Met QC Criteria
May 14, 2021
First Posted (Actual)
May 19, 2021
Study Record Updates
Last Update Posted (Actual)
March 15, 2024
Last Update Submitted That Met QC Criteria
March 12, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-002644
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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