This prospective, randomized-controlled multicenter study investigates whether virtual reality-assisted patient education in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) can improve patient understanding and simulative orientation, thereby reducing postinterventional complications, resulting in significantly shorter length of stay.
High-grade aortic valve stenosis
Indication for elective transfemoral transcatheter aortic valve implantation under analgesia (TAVI)
Existing heart center decision
Age ≥ 18 years
Surgery planned under general anesthesia
Language barrier, defined as insufficient language proficiency at the discretion of the investigator to understand the purpose of the trial and follow the VR application.
Severe hearing impairment, preventing the patient from understanding the sound of the VR goggles, tested with the VR goggles fitted without using the VRAP-Heart software
Severe visual impairment that prevents viewing of the VR modules if it is not possible to use existing visual corrections (contact lenses, glasses) together with the VR glasses in the event of defective vision, tested with the VR goggles fitted without using the VRAP-Heart software
Parallel
Virtual Reality assisted information
Other interventionPatients in the intervention group receive a VR instructional application in the patient's room the day before TAVI implantation and in the operational suite during TAVI implantation the next day. In this application, the patient is guided through different VR parts that repeat the indication, the procedure, the localities and the post-interventional phase of the implantation with the corresponding safety instructions.
Length of hospital stay in days
Primary endpoint is the mean hospital stay in each group in days.
Mental state on the day before the procedure as assessed by visual analog scale
Anxiety and psychological stress are common before elective procedures such as TAVI. Both are considered triggers and amplifiers of delirium. Patients are asked to quantify their anxiety before the procedure using a visual analog scale ranging from 1 to 10.
Mental state on the day before the procedure as assessed by State-Trait-Anxiety-Inventory questionnaire
Anxiety and psychological stress are common before elective procedures such as TAVI. Both are considered triggers and amplifiers of delirium. Patients are asked to quantify their anxiety before the procedure using State-Trait-Anxiety-Inventory with minimum outcome 10 and maximum outcome 80. Lesser outcome means more anxiety.
Mental state on the day before the procedure as assessed by Hospital Anxiety and Depression Scale German Version questionnaire
Anxiety and psychological stress are common before elective procedures such as TAVI. Both are considered triggers and amplifiers of delirium. Patients are asked to quantify their anxiety before the procedure using Hospital Anxiety and Depression Scale German Version questionnaire. Anxiety scale in the questionnaire has values from 0 to 21 and Depression scale has values from 0 to 21. Lesser values denote less anxiety or depression.
Anxiety during the procedure as assessed by visual analog scale
Anxiety and psychological stress are common during elective procedures such as TAVI. Both are considered triggers and amplifiers of delirium. Patients are asked to quantify their anxiety before the procedure using a visual analog scale ranging from 1 to 10.
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Heinrich-Heine University, Duesseldorf
Lead sponsor
Edwards Lifesciences
Collaborator
