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OpenTrials
Completed

NCT Number: NCT03662607

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

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.

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Key information

Conditions

Preprocedure Anxiety Anxiety Disorders Mental Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Corewell Health West

Other

Registry information

Acronym: VR-THEIA

Important dates

Study start
2017
Primary completion
2021
Study completion
2025
First posted
Sep 7, 2018
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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