Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Operative-Vaginal Delivery by Vacuum Extraction on a Pelvic Training Model
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 137
- 试验地点
- 2
- 主要终点
- OSATS scores
研究概览
简要总结
In a prospective, randomized Trial, the investigators compare Hands-on teaching and frontal teaching using a Training Video for learning how to perform an assisted delivery by vacuum extraction on a pelvic Training model. Objective Structured Assessment of Technical Skills (OSATS) scores are the primary outcome. The investigators hypothesize that Hands-on Training is superior to a video-teaching with regard to the OSATS scores achieved by the Trainees.
详细描述
The optimal mode of Training surgical novices how to perform an assisted delivery by means of vacuum extraction is unknown. We prospectively randomize probands to a 30 min hands-on (group 1) and a 30 min demonstration (group 2) training session teaching a standardized vacuum Extraction (VE) algorithm scheme on a pelvic training model. Probands are tested with a 24 item Objective Structured Assessment of Technical Skills (OSATS) scoring system after training and 48 hours, 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medical Student
- •no previous experience in assisted delivery
- •no previous gynecologic surgery training
排除标准
- •language barrier
- •unwillingness to participate
结局指标
主要结局
OSATS scores
时间窗: 5 min after the training
24 predefined OSATS items
次要结局
- OSATS scores after 48 hours(48 hours after the training)
- OSATS scores after 72 hours(72 hours after the training)
研究者
Clemens Tempfer
Prof. Clemens Tempfer, MD
Ruhr University of Bochum
