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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07263659

Enrollment

Registered

2025-12-04

Start date

2021-10-01

Completion date

2024-12-31

Last updated

2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Mitraclip, Mitral Regurgitation, TriClip, Tricuspid Regurgitation (TR), Virtual Reality

Keywords

Virtual Reality, Mitraclip, Triclip

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

Interventions

BEHAVIORALStandard Education plus Virtual Reality (VR)

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Intervention model description

articipants will be randomly assigned to one of two parallel groups: a control group receiving standard pre-procedural information and an intervention group receiving standard information supplemented with a virtual reality (VR) educational session. Outcomes will be compared between groups.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Change in Pre-procedural anxiety	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.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026