Anxiety Reduction in TAVI Using Virtual Reality Trial

Erasmus Medical Center150 enrolled

Overview

The ART-VR Trial is an international multi-center, open label, randomized controlled trial evaluating the effect of an immersive VR environment on procedural anxiety in patients undergoing transfemoral aortic valve replacement (TAVR) under local anaesthesia.

Virtual reality (VR) allows patients to be fully immerged in an engaging, interactive 3D environment. Its applications are broad and include treatment of phobias, stress-disorders, pain reduction. Recently, VR has been adopted in various medical procedures to reduce pre- and per-procedural anxiety. In TAVR, per-procedural VR immersion could potentially reduce patient anxiety leading to increased overall patient satisfaction. However, contemporary large scale, randomized evidence on VR application in TAVR is lacking. The objective of this trial is to evaluate the effect of an immersive VR environment on procedural anxiety in patients undergoing TAVR under local anaesthesia in a randomized controlled setting. A total of 150 patients with severe aortic stenosis (AS) who undergo transfemoral TAVR under local aneasthesia will be included. The main study endpoint is procedural anxiety assessed on a visual analogue scale (VAS) directly post-procedure.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Aortic Stenosis, Severe Anxiety

Interventions

Virtual Reality ImmersionOTHER

An immersive virtual reality experience will be generated by a head mounted device which shows the user pre-recorded videos (SynVR Relax \& Distract, SyncVR Medical BV, Utrecht, The Netherlands). These videos are recorded in 360 degree views and matched with the users' viewing direction by the head mounted device matches. The user will not be able to see its in vivo surroundings (i.e. the Cathlab) and will be focused on the digital content. The VR immersion will be put into place throughout the entire TAVR procedure starting before femoral access obtainment and ending after access closure.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years * Symptomatic severe aortic stenosis * Indication for transfemoral TAVI under local anaesthesia per local heart team consensus * Patient is able to understand and sign written informed consent * Patient speaks Dutch, German or English Exclusion Criteria: * Need for emergent TAVI * Need for planned concomitant cardiac intervention during index procedure * History of TAVI under local anesthesia/conscious sedation * Chronic use of benzodiapines, opioids, pregabalin or antidepressants * History of opioid use (within 8-30 days prior to randomization) * Claustrophobia * Any psychiatric illness diagnosed by a psychiatrist or psychologist * Blindness or severe visual impairment despite visual aid (glasses, contact lenses) * Epilepsy * Extensive cognitive impairment (MMSE \<21 or as diagnosed by geriatrician)

Locations (1)

Erasmus University Medical Center

Rotterdam, South Holland, Netherlands

RECRUITING

Outcomes

Primary Outcomes

Procedural Anxiety

Procedural anxiety assessed on a visual analogue scale directly post-procedure. Range: 0 (no anxiety) to 10 (worst anxiety).

Time frame: Immediately after the TAVR procedure

Secondary Outcomes

Change of Anxiety

Difference between pre-procedural and post-procedural anxiety visual analogue scale scores

Time frame: 1 day (From directly before the TAVR procedure until directly after the TAVR procedure)

Procedural Pain

Procedural pain assessed on a visual analogue scale directly post-procedure. Range: 0 (no pain) to 10 (worst pain).

Time frame: Immediately after the TAVR procedure

Procedural Use of Sedatives

Procedural sedative use and dosage. Amount of benzodiazepine used in milligrams

Time frame: Up to 1 day (Depending on procedure duration)

Procedural Use of Analgesics

Procedural analgesic use and dosage. Amount of Lidocaine (or equivalent) used in milligrams

Time frame: Up to 1 day (Depending on procedure duration)

Patient Procedural Satisfaction

Procedural satisfaction assessed after 24hrs using for procedures under regional anaesthesia. Score assessed on a visual analogue scale. Range: 0 (not at all satisfied) to 10 (very satisfied).

Time frame: One day post procedure

Central Contacts

Nicolas Van Mieghem, MD, PhD

CONTACT

+31107035260 n.vanmieghem@erasmusmc.nl

Data from ClinicalTrials.gov

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