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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02468427
Acronym
VAC-OSATS
Enrollment
137
Registered
2015-06-10
Start date
2015-03-31
Completion date
2015-10-31
Last updated
2022-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

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.

Interventions

OTHERhands-on teaching

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

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

Sponsors

Ruhr University of Bochum
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* language barrier * unwillingness to participate

Design outcomes

Primary

MeasureTime frameDescription
OSATS scores5 min after the training24 predefined OSATS items

Secondary

MeasureTime frameDescription
OSATS scores after 72 hours72 hours after the training24 predefined OSATS items
OSATS scores after 48 hours48 hours after the training24 predefined OSATS items

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026