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Clinical Trials/NCT07263659
NCT07263659
Completed
Not Applicable

Virtual Reality Reduces Pre-Procedural Anxiety in TEER Pa-tients, But Timing Seems Crucial

Abby Geerlings1 site in 1 country75 target enrollmentStarted: October 1, 2021Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Abby Geerlings
Enrollment
75
Locations
1
Primary Endpoint
Change in Pre-procedural anxiety

Overview

Brief Summary

This study aims to evaluate the effect of adding virtual reality (VR) education to standard pre-procedural information on anxiety levels in patients scheduled for MitraClip or TricuspidClip procedures. Participants will receive either standard pre-procedural information or standard information supplemented with a VR experience that explains the procedure and hospital environment. The main outcomes will include changes in patient-reported anxiety before and after the procedure. The goal of this study is to determine whether the use of VR can improve patient understanding, reduce procedural anxiety, and enhance overall well-being

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adults scheduled for elective mitral (M-TEER) or tricuspid (T-TEER) transcatheter edge-to-edge repair procedures.

Exclusion Criteria

  • Insufficient proficiency in Dutch.
  • Severe visual or auditory impairment that would prevent full engagement with the VR content.
  • Any mental or physical condition that, in the judgment of the clinical team, significantly interferes with participation (e.g., advanced cognitive decline, acute psychological distress, or inability to tolerate wearing a VR headset).

Outcomes

Primary Outcomes

Change in Pre-procedural anxiety

Time Frame: 1 week prior to procedure

Change in state anxiety (S-STAI score) immediately after patient education (VR intervention vs. standard verbal education) and onw week prior to the procedure.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Abby Geerlings
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Abby Geerlings

PhD/MD

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Sites (1)

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