Clinical trial NCT05069987: Anxiety Reduction in TAVI Using Virtual Reality Trial
Official title: Anxiety Reduction in TAVI Using Virtual Reality Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Stenosis, Severe
Anxiety
Keywords: Immersive Virtual Reality
Procedural Anxiety
TAVR
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomly assigned, in a 1:1 ratio, to either procedural VR-immersion or non-VR control.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Procedural Anxiety
timeFrame: Immediately after the TAVR procedure
Secondary outcomes:
measure: Change of Anxiety
timeFrame: 1 day (From directly before the TAVR procedure until directly after the TAVR procedure)
measure: Procedural Pain
timeFrame: Immediately after the TAVR procedure
measure: Procedural Use of Sedatives
timeFrame: Up to 1 day (Depending on procedure duration)
measure: Procedural Use of Analgesics
timeFrame: Up to 1 day (Depending on procedure duration)
measure: Patient Procedural Satisfaction
timeFrame: One day post procedure
Other outcomes:
measure: Patient reported procedural Nausea and Vomiting
timeFrame: Up to 1 day (Depending on procedure duration)
measure: Admission time
timeFrame: Up to 7 days
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
state: Zuid Holland
Study officials:
References: