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NCT04279665 Clinical Trial

Virtual Reality to Reduce Intra-procedural Anxiety and Sedation Needs During Procedures

Arrhythmia Clinical Trial

Official title:
Use of Virtual Reality to Reduce Intra-procedural Anxiety and Sedation Needs During Procedures Involving no or Minimal Sedation

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04279665
Other study ID # 19-005788
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date June 20, 2020
Est. completion date January 1, 2021

Study information
Verified date March 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 1, 2021
Est. primary completion date December 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Patients undergoing invasive EP procedures with plan for no or minimal conscious sedation Exclusion Criteria: - Patients unable to consent

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Virtual Reality (VR)
20 minutes of wearing a virtual reality headset with a choice of 4 environments based on their preference and another 20 minutes with a less immersive condition

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Subject anxiety 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). 20 minutes
Primary Subject comfort 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 20 minutes
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