- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06536192
Improving Gynecological Examination Skills with the Use of a Model
February 3, 2025 updated by: Ayse Cuvadar, Karabuk University
Improving Gynecological Examination Skills in Midwifery Students: a Training Study Using Models
Vaginal, abdominal, and breast examinations are among the essential gynecological examination skills for midwifery students and are crucial steps that need to be learned.
However, due to the privacy of genital areas, there are some debates regarding the teaching of these skills.
Low-fidelity mannequins and models are particularly effective and cost-efficient in acquiring basic psychomotor skills.
Thus, midwifery students can gain clinical experience, make mistakes in a safe environment, and enhance their skills.
The sample of this study consists of 64 midwifery students (experimental=32, control=32) using a pre-test, post-test design with an observational randomized controlled trial.
Data collection instruments include a Personal Information Form (PIF), Learner's Guide (LG), Self-Confidence Scale (SCS), and Self-Confidence in Learning Scale (SSSCLS.
In the experimental group, after providing theoretical knowledge, students will receive practical training on a gynecological examination model, including bimanual examination, vaginal examination with a speculum, pap smear for cervical screening, and pelvic palpation.
Each student will then perform the examination individually, with approximately 15 minutes allocated per student.
Two weeks later, the same students will be asked to perform all examination steps again.
During the examinations, the researcher will mark complete and incomplete procedures in the learner's guide, and any deficiencies will be explained to the students for completion.
The CS and SSSLS will be administered for the post-test.
In the control group, after theoretical knowledge is provided, students will be shown visual and video demonstrations of the steps of a gynecological examination.
The PIF and SCS will be administered for the pre-test, and two weeks later, students will be asked to perform the examination steps in a laboratory setting, followed by the post-test.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Gynecological examination is an important step for women's health.
Early diagnosis, treatment, intervention, and follow-up are the foundation of a healthy life.
Midwives play an important role in maintaining women's health, especially in conducting detailed gynecological and obstetric evaluations.
They should receive quality theoretical education and improve their practices.
Practical training is important in learning, especially in the health field where models and simulation applications play a significant role in clinical practices.
Therefore, clinical examination skills are sometimes taught to students using different materials, making it easier for students to learn medical knowledge and reducing the time spent on education.
The aim of this planned study is to improve midwifery students' gynecological examination skills with model support.
Study Type
Interventional
Enrollment (Actual)
68
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
-
-
-
Karabuk, Turkey, 78050
- Ayşe Çuvadar
-
Karabük, Turkey, 78050
- Karabuk University
-
-
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
Description
Inclusion Criteria:
Being a 3rd or 4th year midwifery student at Karabük University Faculty of Health Sciences
- Being between the ages of 18-25
- Voluntarily agreeing to participate in the study
- Being a citizen of the Republic of Turkey
Exclusion Criteria:
- Leave whenever you want without working.
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention (Model) group
|
|
|
No Intervention: Control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improving gynecological examination skills with the use of a model
Time Frame: Groups of 5 people receive 15 minutes of laboratory training and 15 days later, practice in the laboratory.
|
Gynecologic Disease
|
Groups of 5 people receive 15 minutes of laboratory training and 15 days later, practice in the laboratory.
|
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 (Actual)
August 25, 2024
Primary Completion (Actual)
December 30, 2024
Study Completion (Actual)
February 3, 2025
Study Registration Dates
First Submitted
July 22, 2024
First Submitted That Met QC Criteria
July 31, 2024
First Posted (Actual)
August 2, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 3, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-77192459-050.99-338662
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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