Use of Virtual Reality to Reduce Intra-procedural Anxiety and Sedation Needs During Procedures Involving no or Minimal Sedation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Mayo Clinic
- Locations
- 1
- Primary Endpoint
- Subject comfort
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing invasive EP procedures with plan for no or minimal conscious sedation
Exclusion Criteria
- •Patients unable to consent
Arms & Interventions
Subjects undergoing electrophysiology procedure
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.
Intervention: Virtual Reality (VR) (Device)
Outcomes
Primary Outcomes
Subject comfort
Time Frame: 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
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Suraj Kapa
Principal Investigator
Mayo Clinic