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

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ClinicalTrials.gov Identifier: NCT02468427
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : October 7, 2015
Sponsor:
Information provided by (Responsible Party):
Clemens Tempfer, 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.

Condition or disease Intervention/treatment Phase
Surgery Other: hands-on teaching Other: Frontal teaching Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Operative-Vaginal Delivery by Vacuum Extraction on a Pelvic Training Model
Study Start Date : March 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Arm Intervention/treatment
Experimental: hands-on Teaching
Medical students receive a 30 minutes hands-on training session. All study probands perform assisted delivery (operative vaginal delivery) by vacuum extraction on a pelvic model immediately after the training.
Other: hands-on teaching
Training session of 30 minutes duration with every proband performing a vacuum extraction on a pelvic training model.

Active Comparator: Frontal teaching
Medical students receive a 30 minutes frontal teaching session using a training video demonstrating how to perform assisted delivery (operative vaginal delivery) by vacuum extraction on a pelvic model immediately after the training.
Other: Frontal teaching
Training session of 30 minutes duration consisting of a video which demonstrates how to perform a vacuum extraction on a pelvic training model.




Primary Outcome Measures :
  1. OSATS scores [ Time Frame: 5 min after the training ]
    24 predefined OSATS items


Secondary Outcome Measures :
  1. OSATS scores after 48 hours [ Time Frame: 48 hours after the training ]
    24 predefined OSATS items

  2. OSATS scores after 72 hours [ Time Frame: 72 hours after the training ]
    24 predefined OSATS items



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • language barrier
  • unwillingness to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468427


Locations
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Germany
Dept. OBGYN Ruhr University Bochum
Herne, Germany, 44625
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
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Principal Investigator: Clemens B Tempfer, MD Ruhr University Bochum
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Responsible Party: Clemens Tempfer, Prof. Clemens Tempfer, MD, Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT02468427    
Other Study ID Numbers: VACUUM-OSATS
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: October 7, 2015
Last Verified: October 2015