- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06339164
Breech Delivery Skills. Resident Learning Program (Breech)
March 24, 2024 updated by: Claudio Celentano, G. d'Annunzio University
Breech Delivery Skills. Formal Lecture vs Digital Learning in Resident Learning Program.
Breech delivery is one of the mail topic in emergency obstetrics for Italian Board of Obstetrics and Gynecology.
Formal frontal lecture and digital learning represent nowadays the two typical learning methods.
A bedside evaluation it's not feasible due to rarity of such emergency, due to the common senior physicians involvement when it occurs, and due to medico-legal risks.
Mannequin scenario represents the best way of skill evaluation
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Residents will be recruited for "breech delivery" in two different ways.
One group (20) will attend a formal frontal lecture on breech delivery of at least one hour.
A second group matched for sex distribution, age, residency year (20) will receive a digital lecture.
After one month the two groups will test their abilities on a low fidelity mannequin.
The simulation session will be recorded and evaluated by 5 specialists in a blind way.
During the simulation the main topics of breech extraction are recorded.
All residents will receive a questionnaire identifying the subject, previous experience bedside or in a course, and the agreement for video recording and data analysis.
After the simulation test they will receive a second questionnaire indicating improvement levels (using a Kirkpatrick model and a 5-point Likert scale).
Study Type
Observational
Enrollment (Estimated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Claudio Celentano, MD
- Phone Number: +39 3285577305
- Email: celentanoclaudio70@gmail.com
Study Locations
-
-
PE
-
Pescara, PE, Italy, 65100
- Claudio Celentano
-
-
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
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
all residents undergoing lecture for obstetric emergencies
Description
Inclusion Criteria: residents in University of Chieti Medical school -
Exclusion Criteria: none
-
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Formal lecture
residents undergoing frontal lecture one month before the scenario
|
evaluation of different skill retention and learning quality after different learning methods
|
|
Digital learning
residents learning digitally the topic for at least one month before the scenario
|
evaluation of different skill retention and learning quality after different learning methods
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skills capacities
Time Frame: 1 months
|
Skills at the scenario (maneuvers).
Deriving form charts recorded during the scenario and time enalpsed
|
1 months
|
|
Skills capacities
Time Frame: 1 month
|
Skills at the scenario evaluated for 5 supervisors
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
learning qualities
Time Frame: 1 month
|
from questionnaire
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Estimated)
April 15, 2024
Primary Completion (Estimated)
May 15, 2024
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
March 24, 2024
First Submitted That Met QC Criteria
March 24, 2024
First Posted (Actual)
April 1, 2024
Study Record Updates
Last Update Posted (Actual)
April 1, 2024
Last Update Submitted That Met QC Criteria
March 24, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ObGynEASC006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
questionnaire on Goggle forms
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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