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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04279665
Recruitment Status : Suspended (Equipment changed)
First Posted : February 21, 2020
Last Update Posted : December 21, 2020
Sponsor:
Information provided by (Responsible Party):
Suraj Kapa, 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.

Condition or disease Intervention/treatment Phase
Arrhythmia Device: Virtual Reality (VR) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Use of Virtual Reality to Reduce Intra-procedural Anxiety and Sedation Needs During Procedures Involving no or Minimal Sedation
Actual Study Start Date : June 20, 2020
Actual Primary Completion Date : December 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: 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.
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




Primary Outcome Measures :
  1. 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).

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing invasive EP procedures with plan for no or minimal conscious sedation

Exclusion Criteria:

  • Patients unable to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04279665


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Suraj Kapa, MD Mayo Clinic
Additional Information:
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Responsible Party: Suraj Kapa, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04279665    
Other Study ID Numbers: 19-005788
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes