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

NCT07263659 | Completed

• 1 other identifier: W21_185#21.239
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Virtual Reality; Mitraclip; Triclip

Outcome Measures

Primary Outcomes (1)

• Change in Pre-procedural anxiety

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

  1 week prior to procedure

Study Arms (2)

Control Group - Standard Education

NO INTERVENTION

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.

VR Group - Standard Education plus Virtual Reality (VR)

ACTIVE COMPARATOR

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.

Behavioral: Standard Education plus Virtual Reality (VR)

Interventions

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.

Also known as: Virtual reality

VR Group - Standard Education plus Virtual Reality (VR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Abby Geerlings: lead

Study Sites (1)

Amsterdam UMC

Amsterdam, 1105 AZ, Netherlands

Location

MeSH Terms

Conditions

Anxiety Disorders; Mitral Valve Insufficiency; Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Mental Disorders; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD/MD

Model Details: 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.

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: October 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

NL (1)