Anxiety, Aortic Stenosis, Severe
Conditions
Keywords
Immersive Virtual Reality, Procedural Anxiety, TAVR
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.
Interventions
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.
Sponsors
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects will be randomly assigned, in a 1:1 ratio, to either procedural VR-immersion or non-VR control.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Admission time | Up to 7 days | Time leaving cathlab until discharge |
| Patient reported procedural Nausea and Vomiting | Up to 1 day (Depending on procedure duration) | Patient reported nausea and vomiting during the procedure (yes/no) |
Countries
Netherlands
Contacts
Primary ContactNicolas Van Mieghem, MD, PhD
Outcome results
None listed