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

Not Applicable

Active, not recruiting

• Conditions: Preprocedure Anxiety
• Interventions: Behavioral: Virtual reality experience

• Registration Number: NCT03662607
• Lead Sponsor: Spectrum Health Hospitals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-18
• Study First Submitted: 2017-09-27
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-07
• Primary Completion: 2021-11-29
• Results First Submitted: 2025-01-07
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-19
• Last Update Submitted: 2025-02-19
• Results First Posted: 2025-03-11
• Last Update Posted: 2025-03-11
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Virtual reality experience	Standard pre-procedural education plus virtual reality experience for cardiac catheterization.

Primary Outcome Measures

Name	Time	Method
Change in Anxiety Measured by the Sate-Trait Anxiety Inventory (STAI)	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.

Trial Locations

Locations (1)

Spectrum Health; 🇺🇸 Grand Rapids, Michigan, United States