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

Official title

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

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.

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.

Interventions

• Other Virtual Reality assisted information
  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.

Primary outcome measures

• Length of hospital stay in days [Time frame: from start of hospitalizations until hospital leave up until day 360]

Secondary outcome measures (12)

• 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 [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 [Time frame: 1 day before procedure]
• Anxiety during the procedure as assessed by visual analog scale [Time frame: during procedure]
• Anxiety during the procedure as assessed by State-Trait-Anxiety-Inventory questionnaire [Time frame: during procedure]
• Pain during the procedure [Time frame: during procedure]
• Anxiety/stress before, during, and after surgery (measured as serum cortisol) [Time frame: 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). [Time frame: on the 1 day before, during and on day 1-3 after procedure]
• Knowledge test after informed consent [Time frame: 1 day before procedure after informed consent]
• Major bleeding and minor bleeding during hospitalization. [Time frame: at hospital leave up to 360 days after procedure]
• Survival / rehospitalization at 6 and 12 months [Time frame: after 6 and 12 months after hospital leave]
• Maximum length of hospital stay, in days [Time frame: at hospital leave up to 360 days after procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Germany · 2 centers

• Universitätsklinikum Düsseldorf, Klinik für Kardiologie, Pneumologie & Angiologie — Düsseldorf
• Universitätsklinikum Köln, Klinik III für Innere Medizin, Herzzentrum, Kerpener Straße 62 — Cologne

Identifiers

NCT: NCT05552352 · VRAP-Heart

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗