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

Preprocedure Anxiety Clinical Trial

— VR-THEIA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03662607
• Other study ID #: 2017-074
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 18, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Spectrum Health Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: December 31, 2025
• Est. primary completion date: November 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Preprocedure Anxiety

Intervention

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.

Locations

Country	Name	City	State
United States	Spectrum Health	Grand Rapids	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Health Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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