Anxiety Reduction in TAVI using Virtual Reality Trial

Recruiting

Conditions: Anxiety during TAVI
Anxiety during transcatheter aortic valve replacement procedure under local anesthesia
10046973

Registration Number: NL-OMON50951

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 75

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

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 <21 or as diagnosed by geriatrician)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: Procedural anxiety assessed on a visual analogue scale (VAS)<br /><br>directly post-procedure.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Patient procedural satisfaction<br /><br>Change in anxiety pre- vs. postprocedure<br /><br>Procedural pain assessed on a VAS directly post-procedure<br /><br>Procedural sedative use and dosage<br /><br>Procedural analgesic use and dosage<br /><br>Procedural nausea<br /><br>Procedural vomiting<br /><br>Admission time </p><br>