Impact of Virtual Reality on Pre-procedural anxieTy Prior to Heart cathEterIzAtion - VR-THEIA (VR-THEIA)
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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
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Condition or disease | Intervention/treatment | Phase |
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Preprocedure Anxiety | Behavioral: Virtual reality experience | Not Applicable |
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 |
Arm | Intervention/treatment |
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No Intervention: Control
Standard pre-procedural education for cardiac catheterization.
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Experimental: Treatment
Standard pre-procedural education plus virtual reality experience for cardiac catheterization.
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Behavioral: Virtual reality experience
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- 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.
- 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.

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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 |
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

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
Contact: Stacie M VanOosterhout, MEd | 616-391-1162 | stacie.vanoosterhout@spectrumhealth.org |
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 |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
preprocedure anxiety cardiac catheterization |
Anxiety Disorders Mental Disorders |