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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06339164
Other study ID # ObGynEASC006
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 15, 2024
Est. completion date June 30, 2024

Study information

Verified date March 2024
Source G. d'Annunzio University
Contact Claudio Celentano, MD
Phone +39 3285577305
Email celentanoclaudio70@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date June 30, 2024
Est. primary completion date May 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 24 Years to 38 Years
Eligibility Inclusion Criteria: residents in University of Chieti Medical school - Exclusion Criteria: none -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
skills and learning quality in breech delivery
evaluation of different skill retention and learning quality after different learning methods

Locations

Country Name City State
Italy Claudio Celentano Pescara PE

Sponsors (1)

Lead Sponsor Collaborator
G. d'Annunzio University

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Skills capacities Skills at the scenario (maneuvers). Deriving form charts recorded during the scenario and time enalpsed 1 months
Primary Skills capacities Skills at the scenario evaluated for 5 supervisors 1 month
Secondary learning qualities from questionnaire 1 month
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