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

Spectrum Health Hospitals

Status: Active, not recruiting

Conditions: Preprocedure Anxiety

Treatments: Behavioral: Virtual reality experience

Study type: Interventional

Funder types: Other

Identifiers

NCT03662607

2017-074

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Control

No Intervention group

Description:

Standard pre-procedural education for cardiac catheterization.

Treatment

Experimental group

Description:

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

Treatment:

Behavioral: Virtual reality experience