Virtual Reality for Patient Informed Consent in Neurosurgery - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Comparison of intensity of anxiety between intervention and control group
研究概览
简要总结
The goal of this randomized controlled trial is to evaluate benefits of VR (virtual reality)-based patient informed consent in neurosurgery regarding subjective patient comprehension, patient-doctor relationship and anxiety.
详细描述
Additionally, the investigators aim to assess the cost-benefit radio as well as feasibility in a clinical routine setting. Considering the increasing patient participation in decision-making, VR could lead to better understanding of complex surgical procedures, improving the perioperative process for both, patient and surgeon, and reduce anxiety.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the age of 18 and 75
- •Surgical clipping for intracranial aneurysm, resection of vascular malformations
- •Craniotomy and Resection of intracranial tumors that can be segmented for VR
排除标准
- •Visual or auditory impairment with no sufficient aid
- •Patient that had VR informed consent for surgery before
- •Psychiatric illness, cognitive impairment
结局指标
主要结局
Comparison of intensity of anxiety between intervention and control group
时间窗: one time assessment at day 1
Comparison of intensity of physical and cognitive anxiety symptoms will be assessed by the questionnaire Beck Anxiety Inventory (BAI). This questionnaire consists of 21 self-reported items (four-point scale). min score: 39 (minimal anxiety level) max score:174 (severe anxiety)
Comparison of patient doctor relationship between intervention and control group
时间窗: one time assessment at day 1
Comparison of patient doctor relationship will be assessed by PDRQ9 (patient-doctor relationship questionnaire). The questionnaire is a 9-item scale that assesses patients' perception of the relationship with the physician. Items are scored on a 5-point Likert scale ranging from 'not at all appropriate' to 'totally appropriate'. Raw sum scores range from 9 to 45, with higher scores indicating that the patient's perception of the patient-doctor relationship is more favorable.
次要结局
未报告次要终点