MİDWİFERY STUDENTNCT06755216
Practical Birth Simulation for Midwifery Students
A study testing Experimantal group in people with MİDWİFERY STUDENT and Birth, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
Midwifery education consists of two parts: theoretical education and clinical training. Supporting clinical training is as important as theoretical training for the development of students' competencies. 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
- MİDWİFERY STUDENT, Birth
- What is being tested?
- Experimantal group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jan 2025to 26 Jun 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, being between the ages of 18 and 25, voluntarily agreeing to participate in the study.
Who cannot join
- The ability to withdraw from the study at any time, being of male gender.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pelvis-Fetal Head Model With Applied Birth Simulation: Practical Training for Midwifery Students
Midwifery education consists of two parts: theoretical education and clinical training. Supporting clinical training is as important as theoretical training for the development of students' competencies. This simulation training, using the pelvis-fetal head model, will allow students to better understand the difficulties and complications they may encounter during childbirth and to develop the skills to intervene in these situations. This research is a pre-test post-test measurement, observational, randomized controlled study. The population of the research will consist of 3rd and 4th year students studying in the Midwifery department of Karabuk University Faculty of Health Sciences. The research sample will consist of 64 students studying in the 3rd and 4th year of midwifery. Work data will be collected using the Personal Information Form (PIF), Learner's Guide (LG), and Student Satisfaction and Self-Confidence Scale in Learning (SSSCL). Students in the control and experimental groups will be provided with routine theoretical knowledge. During the 2nd stage of labor, cardinal movements performed by the fetal head inside the pelvis will be explained. Subsequently, students will be asked to fill out the PIF and SSSCL for pre-testing. Two weeks later, students will be taken to the laboratory environment to perform the application steps for the theoretical lesson they received and a final test will be administered. While students carry out the examination steps, full-incomplete actions in the Learner's Guide will be marked by a researcher. In short, students in the control group will receive normal theoretical knowledge, and two weeks later, the examination steps and patient evaluation stages will be confirmed. The Study Group; After providing theoretical knowledge to the students, cardinal movements performed by the fetal head in the pelvis during the 2nd stage of labor will be explained practically in a laboratory environment. Students will be taken in groups of 5 and after the explanation of the application, each student will be asked to perform all stages individually. Approximately 15 minutes will be allocated for each student. Two weeks later, the same students will be taken to the laboratory and asked to perform all procedural steps. While students perform the procedural steps, any complete or incomplete applications will be marked by the researcher and then the incomplete applications will be explained to the student for them to complete. LG and SSSCL will be filled out for the final test. SPSS 27 package program will be used for data analysis, and a statistical significance level of 0.05 will be accepted for all analyses
Read the detailed description
The second stage of labor involves cardinal movements of the fetal head within the pelvis. These movements ensure the head's alignment with the pelvis, facilitating rotation and easing delivery. It is important for midwifery students to learn these movements, as intervention may be necessary in case of any complications. Cardinal movements consist of seven key movements, and through these movements, the fetus navigates through the pelvis. Before interacting with pregnant women in clinical settings, it is crucial for midwifery students to master these cardinal and pelvic movements on a model. This ensures that, when in clinics and interacting with pregnant women, students can respond competently, confidently, and effectively. A study conducted by Tarrahi et al. (2022) found that simulation training can impact the performance of students, midwives, and gynecology residents. The increasing use of such training is also believed to improve safety for the pregnant woman, the postpartum mother, and the newborn, enhancing reliability.
This study is designed to reinforce the theoretical knowledge acquired by midwifery students, develop their practical skills, and foster competence through repeated opportunities for trial and error.
- Conditions
- MİDWİFERY STUDENT, Birth
- Being tested
- Experimantal group
- Keywords
- Midwifery, birth, model, raining
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimantal groupBehavioural
Also called Intervention group
In order to identify students who meet the criteria for the study, the PIF and SSSCL will be administered as a pre-test to female students studying in the relevant departments of Karabük University Faculty of Health Sciences.
After providing theoretical information to the students, the cardinal movements of the fetal head within the pelvis during the second stage of labor will be demonstrated in a laboratory setting. Students will be divided into groups of five, and after the demonstration, each student will be asked to perform all stages individually. Approximately 15 minutes will be allocated for each student. Two weeks later, the same students will be brought into the laboratory environment and asked to perform all procedural steps. While performing the steps, a researcher will mark the completed and missing actions on the learner's guide, and any missing steps will be explained to the student and corrected. For the post-test, the Learner's Guide (LG) and SSSCL will be administered
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | In order to identify students who meet the criteria for the study, the PIF and SSSCL will be administered as a pre-test to female students studying in the relevant departments of Karabük University Faculty of Health Sciences.
After providing theoretical information to the students, the cardinal movements of the fetal head within the pelvis during the second stage of labor will be demonstrated in a laboratory setting. Students will be divided into groups of five, and after the demonstration, each student will be asked to perform all stages individually. Approximately 15 minutes will be allocated for each student. Two weeks later, the same students will be brought into the laboratory environment and asked to perform all procedural steps. While performing the steps, a researcher will mark the completed and missing actions on the learner's guide, and any missing steps will be explained to the student and corrected. For the post-test, the Learner's Guide (LG) and SSSCL will be administere Receives: Behavioral: Experimantal group |
| Control group | No intervention | Students in both the control group will receive routine theoretical information. The cardinal movements of the fetal head within the pelvis during the second stage of labor will be explained. Afterwards, students will complete the pre-test using the personal information form (PIF) and Student Satisfaction and Self-Confidence Scale in Learning (SSSCL). Two weeks later, the students will be brought into the laboratory environment, where they will be asked to perform the practical steps of the theoretical lessons they have received, and a post-test will be administered. While performing the examination steps, a researcher will mark any omissions or completions on the learner's guide. In brief, students in the control group will receive regular theoretical information, and two weeks later, the examination steps and patient evaluation stages will be confirmed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Student Satisfaction and Self-Confidence Scale in Learning (SSSCL)
This scale, published by the National League for Nurses (NLN), is used to measure students' attitudes and beliefs regarding simulation. The scale consists of two sub-dimensions, "satisfaction with learning" and "self-confidence," with a total of 13 items. The satisfaction with learning sub-dimension includes 5 items and measures satisfaction with the teaching method, diversity of learning materials, facilitation, motivation, and the overall appropriateness of the simulation. The self-confidence sub-dimension consists of 8 items and evaluates confidence in content sufficiency, content necessity, skill development, the availability of existing resources, and knowledge on how to seek help to solve clinical problems in the simulation. The 13th item of the scale is reverse scored.
The response options for the scale are: 5 = Strongly agree, 4 = Agree, 3 = Neutral: Neither agree nor disagree, 2 = Disagree, 1 = Strongly disagree.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start22 Jan 2025
- Primary completion8 May 2025
- Study completion26 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MİDWİFERY STUDENTStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-group, parallel, prospective, and randomized controlled study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Cuvadar, Karabuk University
- Investigators
- Yağmur Mutlu, Msc, Principal investigator, Karabük University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755216
- Sponsor's protocol ID
- 2024/1895
- Other IDs
- Individual Research Project.
- Status last verified
- Jun 2025
- First submitted
- 19 Dec 2024
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvis-Fetal Head Model With Applied Birth Simulation: Practical Training for Midwifery Students
- ClinicalTrials.gov ID
- NCT06755216
- Acronym / sponsor ID
- 2024/1895
- Conditions
- MİDWİFERY STUDENT, Birth
- Keywords
- Midwifery, birth, model, raining
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 1 Jan 2025 (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.
Midwifery education consists of two parts: theoretical education and clinical training. Supporting clinical training is as important as theoretical training for the development of students' competencies. This simulation training, using the pelvis-fetal head model, will allow students to better understand the difficulties and complications they may encounter during childbirth and to develop the skills to intervene in these situations. This research is a pre-test post-test measurement, observational, randomized controlled study. The population of the research will consist of 3rd and 4th year students studying in the Midwifery department of Karabuk University Faculty of Health Sciences. The research sample will consist of 64 students studying in the 3rd and 4th year of midwifery. Work data will be collected using the Personal Information Form (PIF), Learner's Guide (LG), and Student Satisfaction and Self-Confidence Scale in Learning (SSSCL). Students in the control and experimental groups will be provided with routine theoretical knowledge. During the 2nd stage of labor, cardinal movements performed by the fetal head inside the pelvis will be explained. Subsequently, students will be asked to fill out the PIF and SSSCL for pre-testing. Two weeks later, students will be taken to the laboratory environment to perform the application steps for the theoretical lesson they received and a final test will be administered. While students carry out the examination steps, full-incomplete actions in the Learner's Guide will be marked by a researcher. In short, students in the control group will receive normal theoretical knowledge, and two weeks later, the examination steps and patient evaluation stages will be confirmed. The Study Group; After providing theoretical knowledge to the students, cardinal movements performed by the fetal head in the pelvis during the 2nd stage of labor will be explained practically in a laboratory environment. Students will be taken in groups of 5 and after the explanation of the application, each student will be asked to perform all stages individually. Approximately 15 minutes will be allocated for each student. Two weeks later, the same students will be taken to the laboratory and asked to perform all procedural steps. While students perform the procedural steps, any complete or incomplete applications will be marked by the researcher and then the incomplete applications will be explained to the student for them to complete. LG and SSSCL will be filled out for the final test. SPSS 27 package program will be used for data analysis, and a statistical significance level of 0.05 will be accepted for all analyses
Detailed description
The second stage of labor involves cardinal movements of the fetal head within the pelvis. These movements ensure the head's alignment with the pelvis, facilitating rotation and easing delivery. It is important for midwifery students to learn these movements, as intervention may be necessary in case of any complications. Cardinal movements consist of seven key movements, and through these movements, the fetus navigates through the pelvis. Before interacting with pregnant women in clinical settings, it is crucial for midwifery students to master these cardinal and pelvic movements on a model. This ensures that, when in clinics and interacting with pregnant women, students can respond competently, confidently, and effectively. A study conducted by Tarrahi et al. (2022) found that simulation training can impact the performance of students, midwives, and gynecology residents. The increasing use of such training is also believed to improve safety for the pregnant woman, the postpartum mother, and the newborn, enhancing reliability.
This study is designed to reinforce the theoretical knowledge acquired by midwifery students, develop their practical skills, and foster competence through repeated opportunities for trial and error.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a two-group, parallel, prospective, and randomized controlled study.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Experimantal groupIn order to identify students who meet the criteria for the study, the PIF and SSSCL will be administered as a pre-test to female students studying in the relevant departments of Karabük University Faculty of Health Sciences. After providing theoretical information to the students, the cardinal movements of the fetal head within the pelvis during the second stage of labor will be demonstrated in a laboratory setting. Students will be divided into groups of five, and after the demonstration, each student will be asked to perform all stages individually. Approximately 15 minutes will be allocated for each student. Two weeks later, the same students will be brought into the laboratory environment and asked to perform all procedural steps. While performing the steps, a researcher will mark the completed and missing actions on the learner's guide, and any missing steps will be explained to the student and corrected. For the post-test, the Learner's Guide (LG) and SSSCL will be administere |
| Control group | No intervention | –Students in both the control group will receive routine theoretical information. The cardinal movements of the fetal head within the pelvis during the second stage of labor will be explained. Afterwards, students will complete the pre-test using the personal information form (PIF) and Student Satisfaction and Self-Confidence Scale in Learning (SSSCL). Two weeks later, the students will be brought into the laboratory environment, where they will be asked to perform the practical steps of the theoretical lessons they have received, and a post-test will be administered. While performing the examination steps, a researcher will mark any omissions or completions on the learner's guide. In brief, students in the control group will receive regular theoretical information, and two weeks later, the examination steps and patient evaluation stages will be confirmed. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Being a 3rd or 4th-year Midwifery student, being between the ages of 18 and 25, voluntarily agreeing to participate in the study.
Key exclusion criteria (1 listed)
- The ability to withdraw from the study at any time, being of male gender.
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 |
|---|---|---|
| Experimantal groupAlso: Intervention groupIn order to identify students who meet the criteria for the study, the PIF and SSSCL will be administered as a pre-test to female students studying in the relevant departments of Karabük University Faculty of Health Sciences. After providing theoretical information to the students, the cardinal movements of the fetal head within the pelvis during the second stage of labor will be demonstrated in a laboratory setting. Students will be divided into groups of five, and after the demonstration, each student will be asked to perform all stages individually. Approximately 15 minutes will be allocated for each student. Two weeks later, the same students will be brought into the laboratory environment and asked to perform all procedural steps. While performing the steps, a researcher will mark the completed and missing actions on the learner's guide, and any missing steps will be explained to the student and corrected. For the post-test, the Learner's Guide (LG) and SSSCL will be administered | Behavioural | Intervention group |
Primary outcome
Student Satisfaction and Self-Confidence Scale in Learning (SSSCL)
Time frame: 2 weeks
This scale, published by the National League for Nurses (NLN), is used to measure students' attitudes and beliefs regarding simulation. The scale consists of two sub-dimensions, "satisfaction with learning" and "self-confidence," with a total of 13 items. The satisfaction with learning sub-dimension includes 5 items and measures satisfaction with the teaching method, diversity of learning materials, facilitation, motivation, and the overall appropriateness of the simulation. The self-confidence sub-dimension consists of 8 items and evaluates confidence in content sufficiency, content necessity, skill development, the availability of existing resources, and knowledge on how to seek help to solve clinical problems in the simulation. The 13th item of the scale is reverse scored. The response options for the scale are: 5 = Strongly agree, 4 = Agree, 3 = Neutral: Neither agree nor disagree, 2 = Disagree, 1 = Strongly disagree.
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 1 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
Yağmur Mutlu, Msc principal investigator
Karabük University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimantal group in people with MİDWİFERY STUDENT and Birth, run by Karabuk University at 1 site 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 1 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 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Student Satisfaction and Self-Confidence Scale in Learning (SSSCL) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2025.