Back to resultsObjective Structured Assessment of Technical Skills (OSATS) Evaluation of Shoulder Dystocia Management
Primary Purpose
Shoulder Dystocia
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Hands-On Training
Demonstration
Sponsored by
About this trial
This is an interventional other trial for Shoulder Dystocia focused on measuring shoulder dystocia, training, To assess the effectiveness of hands-on training versus expert demonstration
Eligibility Criteria
Inclusion Criteria:
- informed consent
Exclusion Criteria:
- none
Sites / Locations
- Dept. OBGYN Ruhr University Bochum
- Dept. OBGYN, Ruhr University Bochum
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hands-On Training
Demonstration
Arm Description
30 minutes hands-on training of maneuvers to manage shoulder dystocia
30 minutes passive training by watching an expert instructor explain and perform maneuvers to manage shoulder dystocia
Outcomes
Primary Outcome Measures
OSATS Score
Probands are tested with a 22 item Objective Structured Assessment of Technical Skills (OSATS) scoring system after training and 72 hours thereafter.
Secondary Outcome Measures
Performance Time
Time probands need to perform all test tasks
Global Rating Scale
Predefined score including confidence, speed, and manual capacity to perform test tasks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01618565
Brief Title
Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Shoulder Dystocia Management
Official Title
Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Theoretical Versus Hands-On Training of Shoulder Dystocia Management: a Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Clemens Tempfer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Dystocia
Keywords
shoulder dystocia, training, To assess the effectiveness of hands-on training versus expert demonstration
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
203 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hands-On Training
Arm Type
Experimental
Arm Description
30 minutes hands-on training of maneuvers to manage shoulder dystocia
Arm Title
Demonstration
Arm Type
Active Comparator
Arm Description
30 minutes passive training by watching an expert instructor explain and perform maneuvers to manage shoulder dystocia
Intervention Type
Procedure
Intervention Name(s)
Hands-On Training
Intervention Description
one-time, 30 minute hands-on training
Intervention Type
Procedure
Intervention Name(s)
Demonstration
Intervention Description
30 minutes passive training
Primary Outcome Measure Information:
Title
OSATS Score
Description
Probands are tested with a 22 item Objective Structured Assessment of Technical Skills (OSATS) scoring system after training and 72 hours thereafter.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Performance Time
Description
Time probands need to perform all test tasks
Time Frame
30 minutes
Title
Global Rating Scale
Description
Predefined score including confidence, speed, and manual capacity to perform test tasks
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
informed consent
Exclusion Criteria:
none
Facility Information:
Facility Name
Dept. OBGYN Ruhr University Bochum
City
Herne
ZIP/Postal Code
44625
Country
Germany
Facility Name
Dept. OBGYN, Ruhr University Bochum
City
Herne
ZIP/Postal Code
44625
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
22996098
Citation
Buerkle B, Pueth J, Hefler LA, Tempfer-Bentz EK, Tempfer CB. Objective structured assessment of technical skills evaluation of theoretical compared with hands-on training of shoulder dystocia management: a randomized controlled trial. Obstet Gynecol. 2012 Oct;120(4):809-14. doi: 10.1097/AOG.0b013e31826af9a9.
Results Reference
result
Learn more about this trial
Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Shoulder Dystocia Management
We'll reach out to this number within 24 hrs