Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Theoretical Versus Hands-On Training of Shoulder Dystocia Management: a Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 203
- 试验地点
- 4
- 主要终点
- OSATS Score
研究概览
简要总结
This trial tests whether hands-on training is superior to expert demonstration regarding the management of shoulder dystocia (stuck shoulder) during delivery on a training model.
详细描述
We prospectively randomize probands to a 30 min hands-on (group 1) and a 30 min demonstration (group 2) training session teaching a standardized SD algorithm scheme on a pelvic training model. Probands are tested with a 22 item Objective Structured Assessment of Technical Skills (OSATS) scoring system after training and 72 hours thereafter. OSATS scores are the primary outcome. Performance time (PT), self assessment (SA), confidence (CON), and global rating scale (GRS) are the secondary outcomes. Statistics will beperformed using Mann-Whitney U-test, chi-square test, and multivariable logistic regression analysis.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •informed consent
排除标准
- 未提供
结局指标
主要结局
OSATS Score
时间窗: 30 minutes
Probands are tested with a 22 item Objective Structured Assessment of Technical Skills (OSATS) scoring system after training and 72 hours thereafter.
次要结局
- Performance Time(30 minutes)
- Global Rating Scale(30 minutes)
研究者
Clemens Tempfer
Department head ObGyn
Ruhr University of Bochum