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

NCT ID: NCT02468427

Last Updated: 2022-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-10-31

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.

Conditions

Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

hands-on teaching

Intervention Type: OTHER

Training session of 30 minutes duration with every proband performing a vacuum extraction on a pelvic training model.

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.

Group Type: ACTIVE_COMPARATOR

Frontal teaching

Intervention Type: OTHER

Training session of 30 minutes duration consisting of a video which demonstrates how to perform a vacuum extraction on a pelvic training model.

Interventions

hands-on teaching

Training session of 30 minutes duration with every proband performing a vacuum extraction on a pelvic training model.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• language barrier
• unwillingness to participate

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ruhr University of Bochum

OTHER

Sponsor Role: lead

Responsible Party

Clemens Tempfer

Prof. Clemens Tempfer, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Clemens B Tempfer, MD

Role: PRINCIPAL_INVESTIGATOR

Ruhr University Bochum

Locations

Dept. OBGYN Ruhr University Bochum

Herne, , Germany

Countries

Germany

References

Hilal Z, Kumpernatz AK, Rezniczek GA, Cetin C, Tempfer-Bentz EK, Tempfer CB. A randomized comparison of video demonstration versus hands-on training of medical students for vacuum delivery using Objective Structured Assessment of Technical Skills (OSATS). Medicine (Baltimore). 2017 Mar;96(11):e6355. doi: 10.1097/MD.0000000000006355.

Reference Type: RESULT

PMID: 28296771 (View on PubMed)

Other Identifiers

VACUUM-OSATS

Identifier Type: -

Identifier Source: org_study_id