Anxiety Clinical Trial
— ART-VROfficial title:
Anxiety Reduction in TAVI Using Virtual Reality Trial
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.
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) |
Country | Name | City | State |
---|---|---|---|
Netherlands | Erasmus University Medical Center | Rotterdam | Zuid Holland |
Lead Sponsor | Collaborator |
---|---|
Erasmus Medical Center |
Netherlands,
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 |
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