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OpenTrials
Completed

NCT Number: NCT07263659

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC

Amsterdam, 1105 AZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Standard Education plus Virtual Reality (VR)

Behavioral

Participants in this group will receive the same standard pre-procedural education as the control group, supplemented with an immersive virtual reality (VR) experience. The VR session provides a visual and interactive explanation of the procedure and hospital environment to enhance understanding, reduce anxiety, and improve the overall patient experience.

Other names: Virtual reality

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Abby Geerlings

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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