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

Heinrich-Heine University, Duesseldorf

Status: Enrolling

Conditions: Severe Aortic Valve Stenosis

Treatments: Other: Virtual Reality assisted information

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05552352

VRAP-Heart

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

300 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

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.

Treatment:

Other: Virtual Reality assisted information

Control Arm

No Intervention group

Description:

Patients in the control arm receive no virtual reality assisted information.