Back to resultsImpact of Virtual Reality on Pre-procedural anxieTy Prior to Heart cathEterIzAtion - VR-THEIA (VR-THEIA)
Primary Purpose
Preprocedure Anxiety
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual reality experience
Sponsored by
About this trial
This is an interventional treatment trial for Preprocedure Anxiety focused on measuring preprocedure, anxiety, cardiac catheterization
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
Sites / Locations
- Spectrum Health
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Treatment
Arm Description
Standard pre-procedural education for cardiac catheterization.
Standard pre-procedural education plus virtual reality experience for cardiac catheterization.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03662607
First Posted
September 27, 2017
Last Updated
July 6, 2023
Sponsor
Spectrum Health Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT03662607
Brief Title
Impact of Virtual Reality on Pre-procedural anxieTy Prior to Heart cathEterIzAtion - VR-THEIA
Acronym
VR-THEIA
Official Title
Impact of Virtual Reality on Pre-procedural anxieTy Prior to Heart cathEterIzAtion - VR-THEIA
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 18, 2017 (Actual)
Primary Completion Date
November 29, 2021 (Actual)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spectrum Health Hospitals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preprocedure Anxiety
Keywords
preprocedure, anxiety, cardiac catheterization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard pre-procedural education for cardiac catheterization.
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Standard pre-procedural education plus virtual reality experience for cardiac catheterization.
Intervention Type
Behavioral
Intervention Name(s)
Virtual reality experience
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Anxiety Measured by the STAI
Description
The primary outcome of this study is patient anxiety, as measured by the State Trait Anxiety Inventory (STAI) score.
Time Frame
Change from baseline visit to procedure day. Baseline visits will occur up to 4 weeks prior to procedure.
Secondary Outcome Measure Information:
Title
Sense of Preparedness evaluated by site survey
Description
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.
Time Frame
Procedure day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There are no plans to share data at this time.
Learn more about this trial
Impact of Virtual Reality on Pre-procedural anxieTy Prior to Heart cathEterIzAtion - VR-THEIA
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