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

Heinrich-Heine University, Duesseldorf300 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

300

Conditions

Severe Aortic Valve Stenosis

Interventions

Virtual Reality assisted informationOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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, 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 * Moderately severe or severe dementia syndrome noted in the medical history or identified during the informed consent discussion * 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

Locations (2)

Universitätsklinikum Düsseldorf, Klinik für Kardiologie, Pneumologie & Angiologie

Düsseldorf, North Rhine-Westphalia, Germany

RECRUITING

Universitätsklinikum Köln, Klinik III für Innere Medizin, Herzzentrum, Kerpener Straße 62

Cologne, Germany

RECRUITING

Outcomes

Primary Outcomes

Length of hospital stay in days

Primary endpoint is the mean hospital stay in each group in days.

Time frame: from start of hospitalizations until hospital leave up until day 360

Secondary Outcomes

Mental state on the day before the procedure as assessed by visual analog scale

Time frame: 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.

Time frame: 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.

Time frame: 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.

Central Contacts

Christian Jung, Prof MD PhD

CONTACT

+49 211 81 christian.jung@med.uni-duesseldorf.de

Raphael Bruno, MD

CONTACT

+49 211 81 raphael.bruno@med.uni-duesseldorf.de

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.