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

NCT ID: NCT07263659

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2024-12-31

Brief Summary

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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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control Group - Standard Education

Participants in this group will receive standard pre-procedural education according to the hospital's routine practice. This includes verbal and written information provided by the healthcare team about the MitraClip or TricuspidClip procedure, preparation, and aftercare.

Group Type NO_INTERVENTION

No interventions assigned to this group

VR Group - Standard 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.

Group Type ACTIVE_COMPARATOR

Standard Education plus Virtual Reality (VR)

Intervention Type 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.

Interventions

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Standard 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Virtual reality

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abby Geerlings

OTHER

Sponsor Role lead

Responsible Party

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Abby Geerlings

PhD/MD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Amsterdam UMC

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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W21_185#21.239

Identifier Type: -

Identifier Source: org_study_id

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