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Impact of Virtual Reality on Pre-procedural anxieTy Prior to Heart cathEterIzAtion - VR-THEIA (VR-THEIA)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662607
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Ryan Madder, MD, Spectrum Health Hospitals

Study Description
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Brief Summary:
The primary aim of this study is to test the hypothesis that use of VR combined with standard procedural education will result in less pre-procedural anxiety than standard procedural education alone among patients undergoing first-time cardiac catheterization. The VR technology being evaluated in this study will allow patients to experience a 3-D simulation of certain aspects of their upcoming procedure prior to the actual procedure date.

Condition or disease Intervention/treatment Phase
Preprocedure Anxiety Behavioral: Virtual reality experience Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Virtual Reality on Pre-procedural anxieTy Prior to Heart cathEterIzAtion - VR-THEIA
Actual Study Start Date : April 18, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
Standard pre-procedural education for cardiac catheterization.
Experimental: Treatment
Standard pre-procedural education plus virtual reality experience for cardiac catheterization.
 Behavioral: Virtual reality experience
  • Baseline wellness self-assessment administered (reporting on absence or presence and degree of severity of headache, nausea, dizziness, fatigue and vision abnormalities)
  • Seated comfortably and free of direct obstruction
  • Shown individual components of the VR system (View-Master with smartphone; headphones); given instructions; encouraged to ask questions.
  • Begin the VR experience. Study personnel stay in the room & provide guidance and answer questions regarding the technology
  • When VR experience concluded, wellness self-assessment will be administered again.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Anxiety Measured by the STAI [ Time Frame: Change from baseline visit to procedure day. Baseline visits will occur up to 4 weeks prior to procedure. ]
    The primary outcome of this study is patient anxiety, as measured by the State Trait Anxiety Inventory (STAI) score.


Secondary Outcome Measures :
  1. Sense of Preparedness evaluated by site survey [ Time Frame: Procedure day ]
    The secondary outcome of this study is patient preparedness, as measured by the frequency of "strongly agree" as an answer to a nine question survey about preparedness.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled to undergo a left-heart catheterization procedure at the Meijer Heart Center
  • 18-75 years of age
  • Signed study consent form

Exclusion Criteria:

  • History of cardiac procedure(s) in a cardiac catheterization laboratory
  • History of seizures, migraine headaches or severe susceptibility to motion sickness
  • Currently taking psychotropic drugs or on long-term psychotropic treatment
  • Unable to read and speak English
  • Visually impaired
  • Unable to provide written consent
Contacts and Locations
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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): NCT03662607


Contacts
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Contact: Stacie M VanOosterhout, MEd 616-391-1162 stacie.vanoosterhout@spectrumhealth.org

Locations
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United States, Michigan
Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Stacie M VanOosterhout, MEd    616-391-1162    stacie.vanoosterhout@spectrumhealth.org   
Principal Investigator: Ryan D Madder, MD         
Sponsors and Collaborators
Spectrum Health Hospitals
More Information
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Responsible Party: Ryan Madder, MD, MD, Spectrum Health Hospitals
ClinicalTrials.gov Identifier: NCT03662607    
Other Study ID Numbers: 2017-074
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are no plans to share data at this time.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ryan Madder, MD, Spectrum Health Hospitals:
preprocedure
anxiety
cardiac catheterization
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders