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

Study Overview
=================
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.

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

Conditions
-----------------
Preprocedure Anxiety

Intervention / Treatment
-----------------
* Behavioral: Virtual reality experience


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard pre-procedural education for cardiac catheterization. | |
| Experimental: Treatment<br>Standard pre-procedural education plus virtual reality experience for cardiac catheterization. | Behavioral: Virtual reality experience<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Anxiety Measured by the STAI | The primary outcome of this study is patient anxiety, as measured by the State Trait Anxiety Inventory (STAI) score. | Change from baseline visit to procedure day. Baseline visits will occur up to 4 weeks prior to procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sense of Preparedness evaluated by site survey | The secondary outcome of this study is patient preparedness, as measured by the frequency of strongly agree as an answer to a nine question survey about preparedness. | Procedure day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preprocedure, anxiety, cardiac catheterization