Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Shoulder Dystocia Management

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Theoretical Versus Hands-On Training of Shoulder Dystocia Management: a Randomized Trial

Conditions
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Shoulder Dystocia

Intervention / Treatment
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* Procedure: Hands-On Training
* Procedure: Demonstration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: informed consent Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hands-On Training<br>30 minutes hands-on training of maneuvers to manage shoulder dystocia | Procedure: Hands-On Training<br>* one-time, 30 minute hands-on training<br>|
| Active Comparator: Demonstration<br>30 minutes passive training by watching an expert instructor explain and perform maneuvers to manage shoulder dystocia | Procedure: Demonstration<br>* 30 minutes passive training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OSATS Score | Probands are tested with a 22 item Objective Structured Assessment of Technical Skills (OSATS) scoring system after training and 72 hours thereafter. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance Time | Time probands need to perform all test tasks | 30 minutes | 
| Global Rating Scale | Predefined score including confidence, speed, and manual capacity to perform test tasks | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shoulder dystocia, training, To assess the effectiveness of hands-on training versus expert demonstration