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

July 7, 2022 updated by: Clemens Tempfer, Ruhr University of Bochum

Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Operative-Vaginal Delivery by Vacuum Extraction on a Pelvic Training Model

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

137

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Herne, Germany, 44625
        • Dept. OBGYN Ruhr University Bochum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • language barrier
  • unwillingness to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OSATS scores
Time Frame: 5 min after the training
24 predefined OSATS items
5 min after the training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OSATS scores after 48 hours
Time Frame: 48 hours after the training
24 predefined OSATS items
48 hours after the training
OSATS scores after 72 hours
Time Frame: 72 hours after the training
24 predefined OSATS items
72 hours after the training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruhr University of Bochum

Investigators

  • Principal Investigator: Clemens B Tempfer, MD, Ruhr University Bochum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

May 3, 2015

First Submitted That Met QC Criteria

June 9, 2015

First Posted (Estimate)

June 10, 2015

Study Record Updates

Last Update Posted (Actual)

July 8, 2022

Last Update Submitted That Met QC Criteria

July 7, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • VACUUM-OSATS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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