Anxiety Reduction in TAVI Using Virtual Reality Trial — ART-VR  

Anxiety Clinical Trial

Official title: Anxiety Reduction in TAVI Using Virtual Reality Trial

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Aortic Valve Stenosis

• NCT number: NCT05069987
• Study type: Interventional
• Source: Erasmus Medical Center
• Contact: Nicolas Van Mieghem, MD, PhD
• Phone: +31107035260
• Email: n.vanmieghem@erasmusmc.nl
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2021
• Completion date: May 31, 2023