Impact of Virtual Reality on Pre-procedural anxieTy Prior to Heart cathEterIzAtion - VR-THEIA (VR-THEIA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03662607|
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : October 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Preprocedure Anxiety||Behavioral: Virtual reality experience||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||172 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Virtual Reality on Pre-procedural anxieTy Prior to Heart cathEterIzAtion - VR-THEIA|
|Actual Study Start Date :||April 18, 2017|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2021|
No Intervention: Control
Standard pre-procedural education for cardiac catheterization.
Standard pre-procedural education plus virtual reality experience for cardiac catheterization.
Behavioral: Virtual reality experience
- Change in Anxiety Measured by the STAI [ Time Frame: 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.
- Sense of Preparedness evaluated by site survey [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662607
|Contact: Stacie M VanOosterhout, MEdfirstname.lastname@example.org|
|United States, Michigan|
|Grand Rapids, Michigan, United States, 49503|
|Contact: Stacie M VanOosterhout, MEd 616-391-1162 email@example.com|
|Principal Investigator: Ryan D Madder, MD|