Virtual Reality to Reduce Intra-procedural Anxiety and Sedation Needs During Procedures
Not Applicable
Withdrawn
- Conditions
- Arrhythmia
- Interventions
- Device: Virtual Reality (VR)
- Registration Number
- NCT04279665
- Lead Sponsor
- Mayo Clinic
- Brief Summary
Researchers are assessing whether use of a virtual reality experience, used during the procedure, can reduce anxiety and improve satisfaction related to the procedure, especially when no or little sedation is being used.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Patients undergoing invasive EP procedures with plan for no or minimal conscious sedation
Exclusion Criteria
- Patients unable to consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Subjects undergoing electrophysiology procedure Virtual Reality (VR) Subjects will wear a virtual reality (VR) headset for a total of 40 minutes separated over 2 sessions during an electrophysiology procedure they are already scheduled to undergo.
- Primary Outcome Measures
Name Time Method Subject comfort 20 minutes Measured using a survey question asking participants to rank their comfort over the last 20 minutes using a scale of 5 being extremely positive; 4 being somewhat positive; 3 being neutral; 2 being somewhat negative; 1 being extremely negative
Subject anxiety 20 minutes Measured using a survey question asking participants to rank their anxiety level over the last 20 minutes using a scale of 5 being extremely good (ie, less anxiety); 1 being extremely bad (ie, more anxiety).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States