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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Arrhythmia
• Arrhythmias, Cardiac

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

External Links

•   Mayo Clinic Clinical Trials