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

Sponsor

Spectrum Health Hospitals (Other)

Overall Status

Recruiting

CT.gov ID

NCT03662607

Collaborator

(none)

172

Enrollment

Location

Arms

56.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preprocedure Anxiety	Behavioral: Virtual reality experience	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

172 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 18, 2017

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Standard pre-procedural education for cardiac catheterization.
Experimental: Treatment Standard pre-procedural education plus virtual reality experience for cardiac catheterization.	Behavioral: 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.

Arm

Intervention/Treatment

No Intervention: Control

Standard pre-procedural education for cardiac catheterization.

Experimental: Treatment

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

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

Change in Anxiety Measured by the 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.

Secondary Outcome Measures

Sense of Preparedness evaluated by site survey [Procedure day]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Spectrum Health	Grand Rapids	Michigan	United States	49503

Sponsors and Collaborators

Spectrum Health Hospitals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ryan Madder, MD, MD, Spectrum Health Hospitals

ClinicalTrials.gov Identifier:

NCT03662607

Other Study ID Numbers:

2017-074

First Posted:

Sep 7, 2018

Last Update Posted:

Oct 22, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ryan Madder, MD, MD, Spectrum Health Hospitals

preprocedure

anxiety

cardiac catheterization

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Oct 22, 2020