Anxiety during TAVI Anxiety during transcatheter aortic valve replacement procedure under local anesthesia
Conditions
Interventions
VR-immersion using a head mounted VR-device during TAVI procedure
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: o Age * 18 years o Symptomatic severe aortic stenosis o Indication for transfemoral TAVI under local anaesthesia per local heart team consensus o Patient is able to understand and sign written informed consent o Patient speaks Dutch, German or English
Exclusion criteria
Exclusion criteria: o Need for emergent TAVI o Need for planned concomitant cardiac intervention during index procedure o History of TAVI under local anesthesia/conscious sedation o Chronic use of benzodiapines, opioids, pregabalin or antidepressants o History of opioid use (within 8-30 days prior to randomization) o Claustrophobia o Any psychiatric illness diagnosed by a psychiatrist or psychologist o Blindness or severe visual impairment despite visual aid (glasses, contact lenses) o Epilepsy o Extensive cognitive impairment (MMSE
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Procedural anxiety assessed on a visual analogue scale (VAS) directly post-procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient procedural satisfaction Change in anxiety pre- vs. postprocedure Procedural pain assessed on a VAS directly post-procedure Procedural sedative use and dosage Procedural analgesic use and dosage Procedural nausea Procedural vomiting Admission time | — |
Countries
Netherlands
Outcome results
None listed