Clinical trial NCT05552352: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Aortic Valve Stenosis
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
First posted: 2022-09-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-armed, randomized with controlled parallel groups.
Primary purpose: SUPPORTIVE_CARE

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.

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
* 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

Primary outcomes:
measure: Length of hospital stay in days
timeFrame: from start of hospitalizations until hospital leave up until day 360
Secondary outcomes:
measure: Mental state on the day before the procedure as assessed by visual analog scale
timeFrame: 1 day before procedure
measure: Mental state on the day before the procedure as assessed by State-Trait-Anxiety-Inventory questionnaire
timeFrame: 1 day before procedure
measure: Mental state on the day before the procedure as assessed by Hospital Anxiety and Depression Scale German Version questionnaire
timeFrame: 1 day before procedure
measure: Anxiety during the procedure as assessed by visual analog scale
timeFrame: during procedure
measure: Anxiety during the procedure as assessed by State-Trait-Anxiety-Inventory questionnaire
timeFrame: during procedure
measure: Pain during the procedure
timeFrame: during procedure
measure: Anxiety/stress before, during, and after surgery (measured as serum cortisol)
timeFrame: on the 1 day before, during and on day 1-3 after procedure
measure: Anxiety / stress before, during and after the procedure (amylase and cortisol in saliva).
timeFrame: on the 1 day before, during and on day 1-3 after procedure
measure: Knowledge test after informed consent
timeFrame: 1 day before procedure after informed consent
measure: Major bleeding and minor bleeding during hospitalization.
timeFrame: at hospital leave up to 360 days after procedure
measure: Survival / rehospitalization at 6 and 12 months
timeFrame: after 6 and 12 months after hospital leave
measure: Maximum length of hospital stay, in days
timeFrame: at hospital leave up to 360 days after procedure
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf, Klinik für Kardiologie, Pneumologie & Angiologie
state: NRW
Study officials:
affiliation: Heinrich-Heine University, Duesseldorf
name: Christian Jung, Prof MD PhD
role: PRINCIPAL_INVESTIGATOR
References: