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

April 2, 2026 updated by: Ryan Madder, MD, Corewell Health West
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Anxiety Measured by the Sate-Trait Anxiety Inventory (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. STAI is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety. Scores range from 20 to 80, with higher scores correlating with greater anxiety.
Change from baseline visit to procedure day. Baseline visits will occur up to 4 weeks prior to procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Procedure day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corewell Health West

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2017

Primary Completion (Actual)

November 29, 2021

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

September 27, 2017

First Submitted That Met QC Criteria

September 5, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-074

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are no plans to share data at this time.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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