Brief Title
Anxiety Reduction in TAVI Using Virtual Reality Trial
Official Title
Anxiety Reduction in TAVI Using Virtual Reality Trial
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.
Study Type
Interventional
Primary Outcome
Procedural Anxiety
Secondary Outcome
Change of Anxiety
Condition
Aortic Stenosis, Severe
Intervention
Virtual Reality Immersion
Study Arms / Comparison Groups
VR-immersion
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
150
Start Date
September 16, 2021
Completion Date
May 31, 2023
Primary Completion Date
December 31, 2022
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)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, +31107035260, [email protected]
Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT05069987
Organization ID
MEC-2021-0417
Secondary IDs
NL77298.078.21
Responsible Party
Principal Investigator
Study Sponsor
Erasmus Medical Center
Study Sponsor
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Verification Date
July 2022