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

NCT03662607 | Completed Results

• 1 other identifier: 2017-074
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Preprocedure Anxiety

Keywords

preprocedure; anxiety; cardiac catheterization

Outcome Measures

Primary Outcomes (1)

• Change in Anxiety Measured by the Sate-Trait Anxiety Inventory (STAI)

  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.

Study Arms (2)

Control

NO INTERVENTION

Standard pre-procedural education for cardiac catheterization.

Treatment

EXPERIMENTAL

Standard pre-procedural education plus virtual reality experience for cardiac catheterization.

Behavioral: Virtual reality experience

Interventions

Virtual reality experience BEHAVIORAL

* 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.

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corewell Health West: lead

Study Sites (1)

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Dr. Ryan Madder
• Organization: Spectrum Health

stephen.orey@corewellhealth.org

6163916660

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: September 7, 2018
• Study Start: April 18, 2017
• Primary Completion: November 29, 2021
• Study Completion: December 31, 2025
• Last Updated: April 14, 2026
• Results First Posted: March 11, 2025

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)