- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02664025
Simulation in Teaching Vaginal Examination (VE)
September 6, 2016 updated by: Ahmed Mohamed Abbas, Assiut University
The Benefits of Simulation in Teaching Vaginal Examination for Women During Labor: a Randomized Controlled Study
Teaching technical skills during medical training can lead to some issues, which can concern ethical or medico-legal risks.
In this context, the vaginal examination (VE) is specific because it concerns the genital area and it interferes with obstetrical management.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cairo
-
Assiut, Cairo, Egypt, 002
- Ahmed Abbas
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Interns who finished their study in faculty of medicine
- Interns who never performed VE before
- Interns who accept to participate in the study
Exclusion Criteria:
- Interns who refuse to participate in the study
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
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: simulation group
Interns will carry out 10 VE on a simulator
|
|
|
No Intervention: Control group
Interns who will not perform any simulated VE
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
the improvement of vaginal examination accuracy score after practical training on simulators
Time Frame: 5 minutes
|
5 minutes
|
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
March 1, 2016
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
January 22, 2016
First Submitted That Met QC Criteria
January 25, 2016
First Posted (Estimate)
January 26, 2016
Study Record Updates
Last Update Posted (Estimate)
September 7, 2016
Last Update Submitted That Met QC Criteria
September 6, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- VE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
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.