SurgeryVAC-OSATSNCT02468427
Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Delivery by Vacuum Extraction
A study testing hands-on teaching and Frontal teaching in people with Surgery, run by Ruhr University of Bochum at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgery
- What is being tested?
- hands-on teaching and Frontal teaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2015to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medical Student
- no previous experience in assisted delivery
- no previous gynecologic surgery training
Who cannot join
- language barrier
- unwillingness to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- hands-on teaching, Frontal teaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hands-on teachingOther
Training session of 30 minutes duration with every proband performing a vacuum extraction on a pelvic training model.
Frontal teachingOther
Training session of 30 minutes duration consisting of a video which demonstrates how to perform a vacuum extraction on a pelvic training model.
| Study group | Role | What they receive |
|---|---|---|
| hands-on Teaching | Experimental | 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. Receives: Other: hands-on teaching |
| Frontal teaching | Active comparator | 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. Receives: Other: Frontal teaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSATS scores
24 predefined OSATS items
Measured: 5 min after the training
Secondary outcomes (2)
OSATS scores after 48 hours
24 predefined OSATS items
Measured: 48 hours after the training
OSATS scores after 72 hours
24 predefined OSATS items
Measured: 72 hours after the training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clemens Tempfer, Ruhr University of Bochum
- Investigators
- Clemens B Tempfer, MD, Principal investigator, Ruhr University Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468427
- Sponsor's protocol ID
- VACUUM-OSATS
- Acronym
- VAC-OSATS
- Status last verified
- Jul 2022
- First submitted
- 3 May 2015
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28296771
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Operative-Vaginal Delivery by Vacuum Extraction on a Pelvic Training Model
- ClinicalTrials.gov ID
- NCT02468427
- Acronym / sponsor ID
- VAC-OSATS / VACUUM-OSATS
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 10 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hands-on Teaching | Experimental | Other: hands-on teachingMedical 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 comparator | Other: Frontal teachingMedical 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medical Student
- no previous experience in assisted delivery
- no previous gynecologic surgery training
Key exclusion criteria (2 listed)
- language barrier
- unwillingness to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hands-on teachingTraining session of 30 minutes duration with every proband performing a vacuum extraction on a pelvic training model. | Other | hands-on Teaching |
| Frontal teachingTraining session of 30 minutes duration consisting of a video which demonstrates how to perform a vacuum extraction on a pelvic training model. | Other | Frontal teaching |
Primary outcome
OSATS scores
Time frame: 5 min after the training
24 predefined OSATS items
2 secondary outcomes
OSATS scores after 48 hours
Time frame: 48 hours after the training
OSATS scores after 72 hours
Time frame: 72 hours after the training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Results publication: PubMed 28296771Hilal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clemens B Tempfer, MD principal investigator
Ruhr University Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hands-on teaching and Frontal teaching in people with Surgery, run by Ruhr University of Bochum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSATS scores (time frame: 5 min after the training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02468427, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2022.