Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Delivery by Vacuum Extraction

Not Applicable

Completed

• Conditions: Surgery

• Registration Number: NCT02468427
• Lead Sponsor: Ruhr University of Bochum

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 Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-05-03
• Study First Submitted QC: 2015-06-09
• Study First Posted: 2015-06-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

• Medical Student
• no previous experience in assisted delivery
• no previous gynecologic surgery training

Exclusion Criteria

• language barrier
• unwillingness to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
OSATS scores	5 min after the training	24 predefined OSATS items

Secondary Outcome Measures

Name	Time	Method
OSATS scores after 48 hours	48 hours after the training	24 predefined OSATS items
OSATS scores after 72 hours	72 hours after the training	24 predefined OSATS items

Trial Locations

Locations (1)

Dept. OBGYN Ruhr University Bochum; 🇩🇪 Herne, Germany