Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Operative-Vaginal Delivery by Vacuum Extraction on a Pelvic Training Model
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ruhr University of Bochum
- Enrollment
- 137
- Locations
- 1
- Primary Endpoint
- OSATS scores
Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Medical Student
- •no previous experience in assisted delivery
- •no previous gynecologic surgery training
Exclusion Criteria
- •language barrier
- •unwillingness to participate
Outcomes
Primary Outcomes
OSATS scores
Time Frame: 5 min after the training
24 predefined OSATS items
Secondary Outcomes
- OSATS scores after 48 hours(48 hours after the training)
- OSATS scores after 72 hours(72 hours after the training)
Investigators
Clemens Tempfer
Prof. Clemens Tempfer, MD
Ruhr University of Bochum