Gynecologic NursingNCT06536192
Improving Gynecological Examination Skills with the Use of a Model
A study testing Model group in people with Gynecologic Nursing and Training Group, Sensitivity, run by Karabuk University at 2 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Nursing, Training Group, Sensitivity, Gynecologic Disease
- What is being tested?
- Model group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 25 Aug 2024to 3 Feb 2025
- 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 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Leave whenever you want without working.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Karabük University
Karabük, Karabük Province, 78050
Ayşe Çuvadar
Karabük, Turkey, 78050
About this study
Official title: 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.
Read the 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.
- Being tested
- Model group
- Keywords
- Midwife, student, gynecological examination, model
- Medical subject headings
- Hypersensitivity, Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Model groupOther
- Process: Theoretical knowledge will be given to students, and then different types of gynecological examinations will be explained practically on a model in the laboratory environment.
- Process: The learner guide will be filled out.
- Process: After 15 days, students will be taken back to the laboratory environment to fill out the learner guide again. In addition, SCS and SSSLS will be filled out for the last exam.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Model) group | Experimental | 1. Process: Theoretical knowledge will be given to students, and then different types of gynecological examinations will be explained practically on a model in the laboratory environment.
2. Process: The learner guide will be filled out.
3. Process: After 15 days, students will be taken back to the laboratory environment to fill out the learner guide again. In addition, Self-Confidence Scale (SCS) and Student Satisfaction and Self-Confidence in Learning Scale (SSSLS) will be filled out for the last exam. Receives: Other: Model group |
| Control group | No intervention | 1. Procedure: The stages of gynecological examination evaluation for students, its purpose, the process of preparing the patient and evaluating them will be provided with theoretical knowledge. 2. Procedure: Pre-tests will be administered. 3. Procedure: Two weeks later, Self-Confidence Scale (SCS); Learner's Guide (LG) and (Student Satisfaction and Self-Confidence in Learning Scale) SSSCLS will be filled out for the final test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improving gynecological examination skills with the use of a model
Gynecologic Disease
Measured: Groups of 5 people receive 15 minutes of laboratory training and 15 days later, practice in the laboratory.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start25 Aug 2024
- Primary completion30 Dec 2024
- Study completion3 Feb 2025
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 Gynecologic NursingStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Cuvadar, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536192
- Sponsor's protocol ID
- E-77192459-050.99-338662
- Status last verified
- Feb 2025
- First submitted
- 22 Jul 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cuvadar A, Ozcan H, Can B. Improving gynecological examination skills in midwifery students: A training study using models. Ir J Med Sci. 2026 Jul 1. doi: 10.1007/s11845-026-04514-9. Online ahead of print.
PubMed 42384149
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Gynecological Examination Skills in Midwifery Students: a Training Study Using Models
- ClinicalTrials.gov ID
- NCT06536192
- Acronym / sponsor ID
- E-77192459-050.99-338662
- Keywords
- Midwife, student, gynecological examination, model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 25 Aug 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 3 Feb 2025 (actual)
- First posted
- 2 Aug 2024 (actual)
- 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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (Model) group | Experimental | Other: Model group1. Process: Theoretical knowledge will be given to students, and then different types of gynecological examinations will be explained practically on a model in the laboratory environment. 2. Process: The learner guide will be filled out. 3. Process: After 15 days, students will be taken back to the laboratory environment to fill out the learner guide again. In addition, Self-Confidence Scale (SCS) and Student Satisfaction and Self-Confidence in Learning Scale (SSSLS) will be filled out for the last exam. |
| Control group | No intervention | –1. Procedure: The stages of gynecological examination evaluation for students, its purpose, the process of preparing the patient and evaluating them will be provided with theoretical knowledge. 2. Procedure: Pre-tests will be administered. 3. Procedure: Two weeks later, Self-Confidence Scale (SCS); Learner's Guide (LG) and (Student Satisfaction and Self-Confidence in Learning Scale) SSSCLS will be filled out for the final test. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being a 3rd or 4th year midwifery student at Karabük University Faculty of Health Sciences
Key exclusion criteria (1 listed)
- Leave whenever you want without working.
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 |
|---|---|---|
| Model group1. Process: Theoretical knowledge will be given to students, and then different types of gynecological examinations will be explained practically on a model in the laboratory environment. 2. Process: The learner guide will be filled out. 3. Process: After 15 days, students will be taken back to the laboratory environment to fill out the learner guide again. In addition, SCS and SSSLS will be filled out for the last exam. | Other | Intervention (Model) group |
Primary outcome
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
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 5 Feb 2025.
- Derived from this study: PubMed 42384149Cuvadar A, Ozcan H, Can B. Improving gynecological examination skills in midwifery students: A training study using models. Ir J Med Sci. 2026 Jul 1. doi: 10.1007/s11845-026-04514-9. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Model group in people with Gynecologic Nursing and Training Group, Sensitivity, run by Karabuk University at 2 sites in Turkey (Türkiye).
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 4 inclusion and 1 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 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
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.). 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 NCT06536192, 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 5 Feb 2025.