VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease
- Conditions
- Severe Aortic Valve Stenosis
- Interventions
- Other: Virtual Reality assisted information
- Registration Number
- NCT05552352
- Lead Sponsor
- Heinrich-Heine University, Duesseldorf
- Brief Summary
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.
- Detailed Description
This prospective, randomized-controlled multicenter study investigates whether VR-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. Disorientation, anxiety, and pain can lead to the development of delirium and, through complications, to prolonged hospital stays during elective procedures. Virtual reality can combine different learning modalities (auditory, visual, written, haptic) and improve patient understanding of the procedure through educational interventions. More detailed knowledge of the environment, the players, the procedure, and safety aspects will reduce anxiety and stress before and during the procedure and reduce complications during post-interventional care. As a result, length of stay should be reduced.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- High-grade aortic valve stenosis
- Indication for elective transfemoral transcatheter aortic valve implantation under analgesia (TAVI)
- Existing heart center decision
- Age ≥ 18 years
- Signed informed consent form
- Surgery planned under general anesthesia
- Language barrier
- Severe hearing or vision impairment
- Advanced dementia syndrome
- Known seizure disorder (epilepsy)
- Positive pregnancy test on inclusion and/or pregnancy is present
- Court ordered placement in an institution
- Any psychosocial condition that makes compliance with the protocol unlikely
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Arm Virtual Reality assisted information Patients in the intervention arm receive on the day before the implantation of the artificial aortic valve, a virtual reality assisted information. On the day of the implantation the patients are informed about the process via virtual reality assisted information.
- Primary Outcome Measures
Name Time Method Length of hospital stay in days from start of hospitalizations until hospital leave up until day 360 Primary endpoint is the mean hospital stay in each group in days.
- Secondary Outcome Measures
Name Time Method Anxiety during the procedure as assessed by State-Trait-Anxiety-Inventory questionnaire during procedure 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 State-Trait-Anxiety-Inventory with minimum outcome 10 and maximum outcome 80. Lesser outcome means more anxiety.
Major bleeding and minor bleeding during hospitalization. at hospital leave up to 360 days after procedure Bleeding is a typical complication after cardio-vascular interventional procedures. Unawareness, disorientation, falls, and delirium favor the occurrence of bleeding. After hospital discharge, the occurrence of bleeding is recorded according to Valve Academic Research Consortium-2 consensus document (VARC), which is based on the bleeding academic research consortium (BARC) classification.
Survival / rehospitalization at 6 and 12 months after 6 and 12 months after hospital leave After 6 and 12 months patients are contacted and information is gathered about survival of the patients and possible rehospitalization events.
Anxiety during the procedure as assessed by visual analog scale during procedure 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.
Mental state on the day before the procedure as assessed by visual analog scale 1 day before procedure 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.
Pain during the procedure during procedure Pain can occur despite analgesia during an elective procedure such as TAVI. Pain is considered a trigger and amplifier of delirium. Patients are asked to quantify their pain on a visual analog scale during the procedure (time point: procedure performed but still in the hybrid operating room). Here, 0 corresponds to no pain and 10 to the maximum imaginable pain.
Anxiety / stress before, during and after the procedure (amylase and cortisol in saliva). on the 1 day before, during and on day 1-3 after procedure Patients will have saliva samples taken before, during and after the procedure. From these, the parameters cortisol and alpha-amylase are additionally determined on an optional basis within the scope of this study. Both parameters are considered established to quantify anxiety and stress especially intraindividually.
Maximum length of hospital stay, in days at hospital leave up to 360 days after procedure In addition to the mean hospital stay in days, a maximum hospital stay is also calculated.
Mental state on the day before the procedure as assessed by State-Trait-Anxiety-Inventory questionnaire 1 day before procedure 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 1 day before procedure 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.
Knowledge test after informed consent 1 day before procedure after informed consent In order to test to what extent the addition of a combination of different learning modalities (acoustic, visual, written, haptic) implemented in virtual reality to the medico-legal informed consent is superior to the standard informed consent, a survey is conducted after the informed consent.
Anxiety/stress before, during, and after surgery (measured as serum cortisol) on the 1 day before, during and on day 1-3 after procedure Anxiety and psychological stress are common before and during elective procedures such as TAVI. Both are considered triggers and amplifiers of delirium. Patients will have routine blood samples taken before, during, and after the procedure. From these, the parameter cortisol in serum is additionally determined optionally in the context of this study. Serum cortisol is an established parameter to quantify anxiety and stress, especially intraindividually.
Trial Locations
- Locations (1)
Universitätsklinikum Düsseldorf, Klinik für Kardiologie, Pneumologie & Angiologie
🇩🇪Düsseldorf, NRW, Germany