VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease - A Randomized-Controlled Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Length of hospital stay in days
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention Arm
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.
干预措施: Virtual Reality assisted information (Other)
Control Arm
Patients in the control arm receive no virtual reality assisted information.
结局指标
主要结局
Length of hospital stay in days
时间窗: from start of hospitalizations until hospital leave up until day 360
Primary endpoint is the mean hospital stay in each group in days.
次要结局
- Pain during the procedure(during procedure)
- Anxiety during the procedure as assessed by visual analog scale(during procedure)
- Mental state on the day before the procedure as assessed by visual analog scale(1 day before procedure)
- Anxiety / stress before, during and after the procedure (amylase and cortisol in saliva).(on the 1 day before, during and on day 1-3 after procedure)
- Maximum length of hospital stay, in days(at hospital leave up to 360 days after procedure)
- Anxiety during the procedure as assessed by State-Trait-Anxiety-Inventory questionnaire(during procedure)
- Major bleeding and minor bleeding during hospitalization.(at hospital leave up to 360 days after procedure)
- Survival / rehospitalization at 6 and 12 months(after 6 and 12 months after hospital leave)
- Mental state on the day before the procedure as assessed by State-Trait-Anxiety-Inventory questionnaire(1 day before procedure)
- Mental state on the day before the procedure as assessed by Hospital Anxiety and Depression Scale German Version questionnaire(1 day before procedure)
- Knowledge test after informed consent(1 day before procedure after informed consent)
- Anxiety/stress before, during, and after surgery (measured as serum cortisol)(on the 1 day before, during and on day 1-3 after procedure)