Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Delivery by Vacuum Extraction
VAC-OSATS
1 other identifier
interventional
137
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable surgery
Started Mar 2015
Shorter than P25 for not_applicable surgery
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 3, 2015
CompletedFirst Posted
Study publicly available on registry
June 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedJuly 8, 2022
July 1, 2022
7 months
May 3, 2015
July 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
OSATS scores
24 predefined OSATS items
5 min after the training
Secondary Outcomes (2)
OSATS scores after 48 hours
48 hours after the training
OSATS scores after 72 hours
72 hours after the training
Study Arms (2)
hands-on Teaching
EXPERIMENTALMedical 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.
Frontal teaching
ACTIVE COMPARATORMedical 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Medical Student
- no previous experience in assisted delivery
- no previous gynecologic surgery training
You may not qualify if:
- language barrier
- unwillingness to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept. OBGYN Ruhr University Bochum
Herne, 44625, Germany
Related Publications (1)
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.
PMID: 28296771RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Clemens B Tempfer, MD
Ruhr University Bochum
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Clemens Tempfer, MD
Study Record Dates
First Submitted
May 3, 2015
First Posted
June 10, 2015
Study Start
March 1, 2015
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
July 8, 2022
Record last verified: 2022-07