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

NCT ID: NCT03662607

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-18
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Standard pre-procedural education for cardiac catheterization.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment

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

Group Type: EXPERIMENTAL

Virtual reality experience

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spectrum Health Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Ryan Madder, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Spectrum Health

Grand Rapids, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017-074

Identifier Type: -

Identifier Source: org_study_id