Educational Informed Consent Video in Neurosurgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Patient Comprehension
研究概览
简要总结
This single-center randomized controlled trial addresses a critical gap in neurosurgical practice by evaluating the effectiveness of video-assisted informed consent compared to standard consent procedures.
详细描述
Importance: Informed consent in neurosurgery faces unique challenges due to procedural complexity and limited clinical time, with traditional methods often resulting in suboptimal patient comprehension.
Objective
To determine whether preoperative educational videos improve patient comprehension and satisfaction compared to standard consent procedures in neurosurgical patients.
Design: Single-center, non-blinded randomized controlled trial. Patients are randomized (1:1) using opaque envelope methods.
Setting: Department of Neurosurgery, Kantonsspital St. Gallen, Switzerland. Intervention: Video group receives individualized educational videos plus standard consent. Control group receives standard consent only. Videos coveres surgical indication, anatomy, procedural details, and risks.
Main Outcomes and Measures: Primary outcomes: patient comprehension via standardized questionnaires, satisfaction with consent process, psychological distress (Patient Health Questionnaire-4). Assessments conducted preoperatively and postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •The study population comprises adult patients scheduled for elective neurosurgical intracranial tumor resection
排除标准
- •Patients requiring emergency surgery
- •Patients with cognitive impairments preventing informed consent
- •Patients with significant language barriers impeding effective communication
研究组 & 干预措施
Video Group
Video group receives standard informed consent plus an individualized procedure-specific educational video
干预措施: Educational Informed Consent Video (Procedure)
Video Group
Video group receives standard informed consent plus an individualized procedure-specific educational video
干预措施: Standard informed consent (Procedure)
Control Group
Control group receives standard informed consent, consisting of an in-person verbal consultation with the responsible neurosurgeon supplemented by written documentation and cranial models when applicable
干预措施: Standard informed consent (Procedure)
结局指标
主要结局
Patient Comprehension
时间窗: Measurement at two timepoints: - preoperative: within 24 hours after consenting - postoperative: within 72 hours after surgery
The investigators assess patients' comprehension through standardized questionnaires developed for neurosurgical procedures. Comprehension is evaluated by dichotomized responses: patients answering all questions correctly versus those who did not.
Patient Satisfaction
时间窗: Measurement at two timepoints: - preoperative: within 24 hours after consenting - postoperative: within 72 hours after surgery
The investigators assess patients' satisfaction through standardized questionnaires developed for neurosurgical procedures. To measure satisfaction with consent and information delivery we use a visual analogue scale (0-100, higher scores indicating greater satisfaction).
Psychological Distress
时间窗: Measurement at two timepoints: - preoperative: within 24 hours after consenting - postoperative: within 72 hours after surgery
The investigators evaluate psychological distress using the Patient Health Questionnaire 4 (PHQ-4). The PHQ-4 (Patient Health Questionnaire-4) is a brief, self-administered questionnaire used to screen for both anxiety and depression. It combines the PHQ-2 (a 2-item depression screener) and the GAD-2 (a 2-item anxiety screener). The PHQ-4 is designed to be a quick and easy way to identify individuals who may be experiencing symptoms of anxiety or depression, prompting further evaluation if needed. Scoring: Each item is scored on a 4-point Likert scale (0-3), and the scores are summed for each subscale (GAD-2 and PHQ-2) and the overall PHQ-4.
次要结局
- Satisfaction with hospital stay(Measurement at two timepoints: - preoperative: within 24 hours after consenting - postoperative: within 72 hours after surgery)
研究者
Felix C. Stengel, MD
Principal Investigator
Cantonal Hospital of St. Gallen