VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease - A Randomized-Controlled Multicenter Study

Conditions
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Severe Aortic Valve Stenosis

Intervention / Treatment
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* Other: Virtual Reality assisted information


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-armed, randomized with controlled parallel groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>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. | Other: Virtual Reality assisted information<br>* Patients 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.<br>|
| No Intervention: Control Arm<br>Patients in the control arm receive no virtual reality assisted information. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay in days | Primary endpoint is the mean hospital stay in each group in days. | from start of hospitalizations until hospital leave up until day 360 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 day before procedure | 
| 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. | 1 day before procedure | 
| 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. | 1 day before procedure | 
| 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. | during procedure | 
| Anxiety during the procedure as assessed by State-Trait-Anxiety-Inventory questionnaire | 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. | during procedure | 
| Pain during the 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. | during procedure | 
| Anxiety/stress before, during, and after surgery (measured as serum cortisol) | 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. | on the 1 day before, during and on day 1-3 after procedure | 
| Anxiety / stress before, during and after the procedure (amylase and cortisol in saliva). | 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. | on the 1 day before, during and on day 1-3 after procedure | 
| Knowledge test 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. | 1 day before procedure after informed consent | 
| Major bleeding and minor bleeding during hospitalization. | 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. | at hospital leave up to 360 days after procedure | 
| Survival / rehospitalization at 6 and 12 months | After 6 and 12 months patients are contacted and information is gathered about survival of the patients and possible rehospitalization events. | after 6 and 12 months after hospital leave | 
| Maximum length of hospital stay, in days | In addition to the mean hospital stay in days, a maximum hospital stay is also calculated. | at hospital leave up to 360 days after procedure |