Anxiety Reduction in TAVI Using Virtual Reality Trial
- Conditions
- Aortic Stenosis, SevereAnxiety
- Interventions
- Other: Virtual Reality Immersion
- Registration Number
- NCT05069987
- Lead Sponsor
- Erasmus Medical Center
- Brief 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.
- Detailed 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 & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VR-immersion Virtual Reality Immersion -
- Primary Outcome Measures
Name Time Method Procedural Anxiety Immediately after the TAVR procedure Procedural anxiety assessed on a visual analogue scale directly post-procedure. Range: 0 (no anxiety) to 10 (worst anxiety).
- Secondary Outcome Measures
Name Time Method Change of Anxiety 1 day (From directly before the TAVR procedure until directly after the TAVR procedure) Difference between pre-procedural and post-procedural anxiety visual analogue scale scores
Procedural Pain Immediately after the TAVR procedure Procedural pain assessed on a visual analogue scale directly post-procedure. Range: 0 (no pain) to 10 (worst pain).
Procedural Use of Sedatives Up to 1 day (Depending on procedure duration) Procedural sedative use and dosage. Amount of benzodiazepine used in milligrams
Procedural Use of Analgesics Up to 1 day (Depending on procedure duration) Procedural analgesic use and dosage. Amount of Lidocaine (or equivalent) used in milligrams
Patient Procedural Satisfaction One day post procedure 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).
Trial Locations
- Locations (1)
Erasmus University Medical Center
🇳🇱Rotterdam, Zuid Holland, Netherlands