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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
Sponsor:
Information provided by (Responsible Party):
Ryan Madder, MD, Spectrum Health Hospitals

Tracking Information
First Submitted Date  ICMJE September 27, 2017
First Posted Date  ICMJE September 7, 2018
Last Update Posted Date October 22, 2020
Actual Study Start Date  ICMJE April 18, 2017
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Virtual Reality on Pre-procedural anxieTy Prior to Heart cathEterIzAtion - VR-THEIA
Official Title  ICMJE Impact of Virtual Reality on Pre-procedural anxieTy Prior to Heart cathEterIzAtion - VR-THEIA
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Preprocedure Anxiety
Intervention  ICMJE 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.
Study Arms  ICMJE
  • No Intervention: Control
    Standard pre-procedural education for cardiac catheterization.
  • Experimental: Treatment
    Standard pre-procedural education plus virtual reality experience for cardiac catheterization.
    Intervention: Behavioral: Virtual reality experience
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2018)
172
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stacie M VanOosterhout, MEd 616-391-1162 stacie.vanoosterhout@spectrumhealth.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03662607
Other Study ID Numbers  ICMJE 2017-074
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There are no plans to share data at this time.
Responsible Party Ryan Madder, MD, Spectrum Health Hospitals
Study Sponsor  ICMJE Spectrum Health Hospitals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Spectrum Health Hospitals
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP