Anxiety Reduction in TAVI Using Virtual Reality Trial

Anxiety Clinical Trial

— ART-VR  

Official title:

Anxiety Reduction in TAVI Using Virtual Reality Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05069987
• Other study ID #: MEC-2021-0417
• Secondary ID: NL77298.078.21
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: July 2022
• Source: Erasmus Medical Center
• Contact: Nicolas Van Mieghem, MD, PhD
• Phone: +31107035260
• Email: n.vanmieghem[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Aortic Valve Stenosis

Intervention

Other:
• Virtual Reality Immersion
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.

Locations

Country	Name	City	State
Netherlands	Erasmus University Medical Center	Rotterdam	Zuid Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient reported procedural Nausea and Vomiting	Patient reported nausea and vomiting during the procedure (yes/no)	Up to 1 day (Depending on procedure duration)
Other	Admission time	Time leaving cathlab until discharge	Up to 7 days
Primary	Procedural Anxiety	Procedural anxiety assessed on a visual analogue scale directly post-procedure. Range: 0 (no anxiety) to 10 (worst anxiety).	Immediately after the TAVR procedure
Secondary	Change of Anxiety	Difference between pre-procedural and post-procedural anxiety visual analogue scale scores	1 day (From directly before the TAVR procedure until directly after the TAVR procedure)
Secondary	Procedural Pain	Procedural pain assessed on a visual analogue scale directly post-procedure. Range: 0 (no pain) to 10 (worst pain).	Immediately after the TAVR procedure
Secondary	Procedural Use of Sedatives	Procedural sedative use and dosage. Amount of benzodiazepine used in milligrams	Up to 1 day (Depending on procedure duration)
Secondary	Procedural Use of Analgesics	Procedural analgesic use and dosage. Amount of Lidocaine (or equivalent) used in milligrams	Up to 1 day (Depending on procedure duration)
Secondary	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).	One day post procedure