EpisiotomyEpisiotomyNCT07899658
Model-Based Episiotomy Training
A study testing Model-Based Episiotomy Simulation Training in people with Episiotomy, run by Kırklareli University.
Trial summary
This study aims to evaluate whether practical episiotomy training using simulation models improves midwifery students' confidence in their ability to perform the procedure, their confidence in learning, and their satisfaction with the training. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Episiotomy
- What is being tested?
- Model-Based Episiotomy Simulation Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 19 Oct 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary agreement to participate in the study
- Ability to speak and understand Turkish
- Age 18 years or older
- Being a third-year undergraduate midwifery student
- Taking the Childbirth Knowledge III course for the first time
Who cannot join
- Not agreeing to participate in the study
- Inability to speak or understand Turkish
- Being younger than 18 years
- Not being a third-year undergraduate midwifery student
- Repeating the Childbirth Knowledge III course due to previous failure or for grade improvement
About this study
Official title: The Effectiveness of Episiotomy Training Using Model-Based Simulation: A Randomized Controlled Study
This study aims to evaluate whether practical episiotomy training using simulation models improves midwifery students' confidence in their ability to perform the procedure, their confidence in learning, and their satisfaction with the training.
An episiotomy is a surgical cut made in the area between the vaginal opening and the anus during childbirth when medically necessary. Proper repair of this cut and any tears that may occur during childbirth is important for maternal health. Therefore, midwifery students need to develop appropriate knowledge and skills before graduation. Practicing on simulation models may help students gain experience and confidence in a safe learning environment before performing procedures on real patients.
Read more
The study will be conducted among third-year midwifery students at the Faculty of Health Sciences, Kırklareli University, Türkiye. Students aged 18 years or older who are taking the Childbirth Knowledge III course for the first time will be eligible to participate. Approximately 90-100 students are expected to take part. Participation will be voluntary.
Students who agree to participate will be randomly assigned by computer to one of two groups. The first group will receive standard episiotomy education, including a presentation and an educational video. The second group will receive the same standard education plus hands-on practice using special episiotomy simulation models. Practical training will be conducted in small groups under the guidance of the researchers.
Before training, all students will complete a questionnaire about their background and educational experience, as well as questions assessing how confident they feel in their ability to perform episiotomy-related procedures. Immediately after training, students will complete questionnaires assessing their satisfaction with the education and their confidence in learning. One month later, their perceived ability to perform episiotomy-related procedures will be assessed again. After all assessments are completed, students in the standard education group will also be offered the opportunity to practice using simulation models.
No procedures will be performed on real patients as part of this study. Participants' information will be kept confidential and used only for scientific purposes. Students may withdraw from the study at any time.
The study will examine whether adding hands-on simulation training to standard education improves students' confidence, perceived ability, and satisfaction with learning. The findings may help improve midwifery education and contribute to better quality maternity care in the future.
Read the detailed description
### Background and Rationale
This study is designed to evaluate the effectiveness of model-based simulation training in improving midwifery students' perceived self-efficacy regarding episiotomy-related procedures, self-confidence in learning, and satisfaction with education. The study will compare conventional education with conventional education supplemented by hands-on training using episiotomy simulation models.
An episiotomy is a surgical incision made in the perineum, the area between the vaginal opening and the anus, during childbirth when clinically indicated. Perineal tears may also occur during vaginal birth. Appropriate repair of episiotomy incisions and childbirth-related perineal injuries is important for maternal recovery and postpartum health.
Midwives play an important role in providing care during childbirth. Therefore, acquiring appropriate knowledge and practical skills related to episiotomy and perineal repair is an important component of midwifery education.
Traditional teaching approaches, including lectures, presentations, and educational videos, are commonly used in midwifery programs. However, theoretical education alone may not provide sufficient opportunities for students to develop confidence in procedures requiring practical and technical skills, such as suturing and perineal repair.
Simulation-based education allows students to practice clinical procedures using specially designed models without involving real patients. This educational approach provides opportunities for repeated practice, instructor guidance, and feedback in a controlled learning environment.
Previous research suggests that simulation-based education may improve students' confidence, perceived competence, and satisfaction with learning. Nevertheless, additional evidence is needed regarding the effectiveness of model-based episiotomy training compared with conventional education among undergraduate midwifery students.
### Study Objective
The primary objective of this study is to determine whether adding model-based simulation training to conventional episiotomy education improves midwifery students' perceived self-efficacy regarding episiotomy-related procedures.
The study will also evaluate the effects of the educational approaches on students' self-confidence in learning and satisfaction with the educational experience.
The researchers hypothesize that students receiving additional hands-on simulation training will demonstrate higher perceived self-efficacy, learning self-confidence, and educational satisfaction than students receiving conventional education alone.
### Study Design and Setting
This study is planned as a single-center, two-arm, randomized controlled educational trial.
The research will be conducted at the Department of Midwifery, Faculty of Health Sciences, Kırklareli University, Türkiye, during the 2026-2027 academic year.
The study population will consist of third-year undergraduate midwifery students enrolled in the Childbirth Knowledge III course during the fall semester.
Approximately 90-100 students are expected to be eligible for participation. The researchers aim to recruit all students who meet the eligibility criteria and voluntarily agree to participate.
Eligible participants will be randomly assigned to either the intervention group or the control group using a computer-generated simple randomization procedure. Each participant will receive an identification number for the randomization process, and allocation will be conducted to distribute participants between the two groups in an unbiased manner.
### Eligibility Criteria
Participants will be eligible if they are aged 18 years or older, can speak and understand Turkish, are third-year undergraduate midwifery students, are taking the Childbirth Knowledge III course for the first time, and voluntarily agree to participate.
Students who do not provide consent, are younger than 18 years, cannot speak or understand Turkish, are not third-year midwifery students, or are repeating the course will not be included.
### Educational Interventions
Control Group: Conventional Episiotomy Education
Participants assigned to the control group will receive standard education related to episiotomy.
The educational intervention will consist of a slide presentation and an instructional video addressing episiotomy-related knowledge and procedures.
No hands-on simulation practice using episiotomy models will be provided to this group during the initial intervention and assessment period.
This group will serve as the comparison group for evaluating the additional effects of model-based simulation training.
Intervention Group: Conventional Education Plus Model-Based Simulation
Participants assigned to the intervention group will receive the same standard education as the control group, followed by additional hands-on training using episiotomy simulation models.
Students will practice episiotomy-related procedures on specially designed training models under the supervision and guidance of the research team.
Approximately seven to eight simulation models are expected to be available. Therefore, participants will complete the practical training in small groups to facilitate active participation and supervised practice.
The principal investigator and four assistant researchers will support the training process, provide guidance, and help maintain consistency in the implementation of the educational intervention.
All educational activities will be conducted in a classroom setting.
No episiotomy procedures, surgical incisions, or suturing procedures will be performed on real patients as part of this study.
Following completion of the one-month outcome assessments in both groups, participants in the control group will also be offered hands-on practice using episiotomy simulation models.
### Data Collection and Assessment Schedule
Data will be collected using a participant information form and two established questionnaires.
Baseline Assessment
Before the educational intervention, participants in both groups will complete a 12-item participant information form developed by the researchers.
The form will collect information about demographic characteristics, educational background, and previous knowledge and experiences related to episiotomy.
Participants will also complete the Episiotomy Self-Efficacy Scale before training.
The Episiotomy Self-Efficacy Scale consists of 17 items covering cognitive, affective, motivational, and psychomotor dimensions of perceived self-efficacy related to episiotomy procedures and repair.
Each item is scored using a five-point response scale. Total scores range from 17 to 85, with higher scores indicating greater perceived episiotomy self-efficacy.
Immediate Post-Training Assessment
Immediately after completing their assigned educational intervention, participants in both groups will complete the Student Satisfaction and Self-Confidence in Learning Scale.
This instrument contains 13 items assessing two dimensions: satisfaction with learning and self-confidence in learning.
The questionnaire evaluates participants' perceptions of the educational approach, the learning experience, and their confidence in acquiring and applying the educational content.
Total scores range from 13 to 65, with higher scores indicating greater satisfaction and self-confidence in learning.
One-Month Follow-Up Assessment
One month after the educational intervention, participants in both groups will complete the Episiotomy Self-Efficacy Scale again.
This follow-up assessment is intended to determine whether students' perceived self-efficacy regarding episiotomy-related procedures has changed after the educational intervention.
Baseline and one-month scores will be compared to examine changes within each group and differences between the groups.
The one-month assessment will also help determine whether any differences in perceived self-efficacy remain detectable beyond the immediate training period.
### Outcome Measures
The main outcome of interest will be perceived episiotomy self-efficacy, assessed using the Episiotomy Self-Efficacy Scale before training and one month after training.
Additional outcomes will include student satisfaction with learning and self-confidence in learning, assessed immediately after the educational intervention.
The study will compare the two educational approaches to determine whether additional model-based simulation practice is associated with differences in these outcomes.
The study does not include direct assessment of clinical performance on real patients. Therefore, the findings will reflect students' self-reported perceptions of their abilities and educational experiences rather than objectively measured clinical competence.
### Statistical Analysis
The collected data will be analyzed using statistical software.
Descriptive statistics, including frequencies, percentages, means, and standard deviations, will be used to summarize participant characteristics and study outcomes.
Baseline characteristics and initial assessment scores will be compared between the intervention and control groups.
Changes in episiotomy self-efficacy scores from baseline to the one-month follow-up will be evaluated within each group.
Between-group comparisons will be performed to assess differences in episiotomy self-efficacy at the one-month follow-up and differences in post-training satisfaction and self-confidence in learning.
Appropriate parametric or nonparametric statistical tests will be selected according to the distribution and characteristics of the data.
Statistical significance will be defined as a p-value below 0.05.
### Ethical Considerations and Participant Safety
Before study implementation, approval from the relevant ethics committee and institutional authorization will be obtained.
All eligible students will receive information about the purpose of the study, the educational procedures, the assessment schedule, and the voluntary nature of participation.
Written informed consent will be obtained from students who agree to participate.
Participants will be informed that they may withdraw from the research at any time.
All collected information will be kept confidential and used only for scientific research purposes.
The intervention is educational and will be conducted using simulation models in a classroom environment. No clinical procedures will be performed on patients as part of the study.
### Expected Contributions and Study Limitations
This study is expected to provide evidence regarding the effectiveness of adding hands-on model-based simulation training to conventional episiotomy education in undergraduate midwifery programs.
The findings may help educators determine whether simulation-based practice improves students' perceived self-efficacy, confidence in learning, and satisfaction with their educational experience.
The study has several limitations. It will be conducted at a single university, which may limit the generalizability of the findings to other educational institutions.
Furthermore, the outcomes will be measured using self-reported questionnaires rather than direct observations of clinical performance. Consequently, improvements in perceived self-efficacy should not be interpreted as confirmed improvements in actual clinical competence.
The follow-up period will be limited to one month, preventing conclusions about the longer-term effects of simulation training.
Despite these limitations, the study may contribute to the development of more effective teaching approaches in midwifery education and support future research on simulation-based clinical skills training.
In the longer term, improvements in midwifery education may contribute to better preparation of future midwives and potentially support the quality of maternity care.
- Conditions
- Episiotomy
- Being tested
- Model-Based Episiotomy Simulation Training
- Keywords
- Episiotomy, Simulation Training, Students, Midwifery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Model-Based Episiotomy Simulation TrainingOther
Participants will receive hands-on episiotomy training using simulation models in small groups, under the guidance of researchers, in addition to standard education consisting of a presentation and an educational video.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Participants in this group will receive standard episiotomy education consisting of a presentation and an educational video, followed by hands-on training using episiotomy simulation models. Training will be conducted in small groups under the supervision of the researchers. Receives: Other: Model-Based Episiotomy Simulation Training |
| Active Comparator Arm | No intervention | Participants in this group will receive standard episiotomy education consisting of a presentation and an educational video without initial hands-on simulation training. After completion of the one-month follow-up assessments, participants will also be offered practical training using episiotomy simulation models. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Episiotomy Self-Efficacy
Episiotomy self-efficacy will be assessed using the 17-item Episiotomy Self-Efficacy Scale, which evaluates students' perceived ability to perform episiotomy-related procedures. Total scores range from 17 to 85, with higher scores indicating greater perceived self-efficacy. Changes in scores will be compared between the intervention and control groups.
Measured: Baseline and one month after the educational intervention
Secondary outcomes (1)
Student Satisfaction and Self-Confidence in Learning
Student satisfaction and self-confidence in learning will be assessed using the 13-item Student Satisfaction and Self-Confidence in Learning Scale. The scale includes two subscales: satisfaction with learning (5 items) and self-confidence in learning (8 items). Total scores range from 13 to 65, with higher scores indicating greater satisfaction and self-confidence in learning. Scores will be compared between the intervention and control groups.
Measured: Immediately after the educational intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start19 Oct 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpisiotomyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a two-arm, parallel-group, randomized controlled trial. Eligible participants will be randomly assigned to the intervention or control group using computer-generated simple randomization. The control group will receive standard episiotomy education consisting of a presentation and an educational video. The intervention group will receive the same standard education supplemented by hands-on training using episiotomy simulation models. Episiotomy self-efficacy will be assessed at baseline and one month after training, while student satisfaction and self-confidence in learning will be evaluated immediately after training. Following completion of the one-month assessments, control group participants will also be offered hands-on simulation training.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seçil Hür, Kırklareli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899658
- Sponsor's protocol ID
- KırklareliU-EBE-SH-02
- Acronym
- Episiotomy
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Episiotomy Training Using Model-Based Simulation: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07899658
- Acronym / sponsor ID
- Episiotomy / KırklareliU-EBE-SH-02
- Conditions
- Episiotomy
- Keywords
- Episiotomy, Simulation Training, Students, Midwifery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 19 Oct 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 27 Oct 2026 (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.
This study aims to evaluate whether practical episiotomy training using simulation models improves midwifery students' confidence in their ability to perform the procedure, their confidence in learning, and their satisfaction with the training.
An episiotomy is a surgical cut made in the area between the vaginal opening and the anus during childbirth when medically necessary. Proper repair of this cut and any tears that may occur during childbirth is important for maternal health. Therefore, midwifery students need to develop appropriate knowledge and skills before graduation. Practicing on simulation models may help students gain experience and confidence in a safe learning environment before performing procedures on real patients.
The study will be conducted among third-year midwifery students at the Faculty of Health Sciences, Kırklareli University, Türkiye. Students aged 18 years or older who are taking the Childbirth Knowledge III course for the first time will be eligible to participate. Approximately 90-100 students are expected to take part. Participation will be voluntary.
Students who agree to participate will be randomly assigned by computer to one of two groups. The first group will receive standard episiotomy education, including a presentation and an educational video. The second group will receive the same standard education plus hands-on practice using special episiotomy simulation models. Practical training will be conducted in small groups under the guidance of the researchers.
Before training, all students will complete a questionnaire about their background and educational experience, as well as questions assessing how confident they feel in their ability to perform episiotomy-related procedures. Immediately after training, students will complete questionnaires assessing their satisfaction with the education and their confidence in learning. One month later, their perceived ability to perform episiotomy-related procedures will be assessed again. After all assessments are completed, students in the standard education group will also be offered the opportunity to practice using simulation models.
No procedures will be performed on real patients as part of this study. Participants' information will be kept confidential and used only for scientific purposes. Students may withdraw from the study at any time.
The study will examine whether adding hands-on simulation training to standard education improves students' confidence, perceived ability, and satisfaction with learning. The findings may help improve midwifery education and contribute to better quality maternity care in the future.
Detailed description
### Background and Rationale
This study is designed to evaluate the effectiveness of model-based simulation training in improving midwifery students' perceived self-efficacy regarding episiotomy-related procedures, self-confidence in learning, and satisfaction with education. The study will compare conventional education with conventional education supplemented by hands-on training using episiotomy simulation models.
An episiotomy is a surgical incision made in the perineum, the area between the vaginal opening and the anus, during childbirth when clinically indicated. Perineal tears may also occur during vaginal birth. Appropriate repair of episiotomy incisions and childbirth-related perineal injuries is important for maternal recovery and postpartum health.
Midwives play an important role in providing care during childbirth. Therefore, acquiring appropriate knowledge and practical skills related to episiotomy and perineal repair is an important component of midwifery education.
Traditional teaching approaches, including lectures, presentations, and educational videos, are commonly used in midwifery programs. However, theoretical education alone may not provide sufficient opportunities for students to develop confidence in procedures requiring practical and technical skills, such as suturing and perineal repair.
Simulation-based education allows students to practice clinical procedures using specially designed models without involving real patients. This educational approach provides opportunities for repeated practice, instructor guidance, and feedback in a controlled learning environment.
Previous research suggests that simulation-based education may improve students' confidence, perceived competence, and satisfaction with learning. Nevertheless, additional evidence is needed regarding the effectiveness of model-based episiotomy training compared with conventional education among undergraduate midwifery students.
### Study Objective
The primary objective of this study is to determine whether adding model-based simulation training to conventional episiotomy education improves midwifery students' perceived self-efficacy regarding episiotomy-related procedures.
The study will also evaluate the effects of the educational approaches on students' self-confidence in learning and satisfaction with the educational experience.
The researchers hypothesize that students receiving additional hands-on simulation training will demonstrate higher perceived self-efficacy, learning self-confidence, and educational satisfaction than students receiving conventional education alone.
### Study Design and Setting
This study is planned as a single-center, two-arm, randomized controlled educational trial.
The research will be conducted at the Department of Midwifery, Faculty of Health Sciences, Kırklareli University, Türkiye, during the 2026-2027 academic year.
The study population will consist of third-year undergraduate midwifery students enrolled in the Childbirth Knowledge III course during the fall semester.
Approximately 90-100 students are expected to be eligible for participation. The researchers aim to recruit all students who meet the eligibility criteria and voluntarily agree to participate.
Eligible participants will be randomly assigned to either the intervention group or the control group using a computer-generated simple randomization procedure. Each participant will receive an identification number for the randomization process, and allocation will be conducted to distribute participants between the two groups in an unbiased manner.
### Eligibility Criteria
Participants will be eligible if they are aged 18 years or older, can speak and understand Turkish, are third-year undergraduate midwifery students, are taking the Childbirth Knowledge III course for the first time, and voluntarily agree to participate.
Students who do not provide consent, are younger than 18 years, cannot speak or understand Turkish, are not third-year midwifery students, or are repeating the course will not be included.
### Educational Interventions
Control Group: Conventional Episiotomy Education
Participants assigned to the control group will receive standard education related to episiotomy.
The educational intervention will consist of a slide presentation and an instructional video addressing episiotomy-related knowledge and procedures.
No hands-on simulation practice using episiotomy models will be provided to this group during the initial intervention and assessment period.
This group will serve as the comparison group for evaluating the additional effects of model-based simulation training.
Intervention Group: Conventional Education Plus Model-Based Simulation
Participants assigned to the intervention group will receive the same standard education as the control group, followed by additional hands-on training using episiotomy simulation models.
Students will practice episiotomy-related procedures on specially designed training models under the supervision and guidance of the research team.
Approximately seven to eight simulation models are expected to be available. Therefore, participants will complete the practical training in small groups to facilitate active participation and supervised practice.
The principal investigator and four assistant researchers will support the training process, provide guidance, and help maintain consistency in the implementation of the educational intervention.
All educational activities will be conducted in a classroom setting.
No episiotomy procedures, surgical incisions, or suturing procedures will be performed on real patients as part of this study.
Following completion of the one-month outcome assessments in both groups, participants in the control group will also be offered hands-on practice using episiotomy simulation models.
### Data Collection and Assessment Schedule
Data will be collected using a participant information form and two established questionnaires.
Baseline Assessment
Before the educational intervention, participants in both groups will complete a 12-item participant information form developed by the researchers.
The form will collect information about demographic characteristics, educational background, and previous knowledge and experiences related to episiotomy.
Participants will also complete the Episiotomy Self-Efficacy Scale before training.
The Episiotomy Self-Efficacy Scale consists of 17 items covering cognitive, affective, motivational, and psychomotor dimensions of perceived self-efficacy related to episiotomy procedures and repair.
Each item is scored using a five-point response scale. Total scores range from 17 to 85, with higher scores indicating greater perceived episiotomy self-efficacy.
Immediate Post-Training Assessment
Immediately after completing their assigned educational intervention, participants in both groups will complete the Student Satisfaction and Self-Confidence in Learning Scale.
This instrument contains 13 items assessing two dimensions: satisfaction with learning and self-confidence in learning.
The questionnaire evaluates participants' perceptions of the educational approach, the learning experience, and their confidence in acquiring and applying the educational content.
Total scores range from 13 to 65, with higher scores indicating greater satisfaction and self-confidence in learning.
One-Month Follow-Up Assessment
One month after the educational intervention, participants in both groups will complete the Episiotomy Self-Efficacy Scale again.
This follow-up assessment is intended to determine whether students' perceived self-efficacy regarding episiotomy-related procedures has changed after the educational intervention.
Baseline and one-month scores will be compared to examine changes within each group and differences between the groups.
The one-month assessment will also help determine whether any differences in perceived self-efficacy remain detectable beyond the immediate training period.
### Outcome Measures
The main outcome of interest will be perceived episiotomy self-efficacy, assessed using the Episiotomy Self-Efficacy Scale before training and one month after training.
Additional outcomes will include student satisfaction with learning and self-confidence in learning, assessed immediately after the educational intervention.
The study will compare the two educational approaches to determine whether additional model-based simulation practice is associated with differences in these outcomes.
The study does not include direct assessment of clinical performance on real patients. Therefore, the findings will reflect students' self-reported perceptions of their abilities and educational experiences rather than objectively measured clinical competence.
### Statistical Analysis
The collected data will be analyzed using statistical software.
Descriptive statistics, including frequencies, percentages, means, and standard deviations, will be used to summarize participant characteristics and study outcomes.
Baseline characteristics and initial assessment scores will be compared between the intervention and control groups.
Changes in episiotomy self-efficacy scores from baseline to the one-month follow-up will be evaluated within each group.
Between-group comparisons will be performed to assess differences in episiotomy self-efficacy at the one-month follow-up and differences in post-training satisfaction and self-confidence in learning.
Appropriate parametric or nonparametric statistical tests will be selected according to the distribution and characteristics of the data.
Statistical significance will be defined as a p-value below 0.05.
### Ethical Considerations and Participant Safety
Before study implementation, approval from the relevant ethics committee and institutional authorization will be obtained.
All eligible students will receive information about the purpose of the study, the educational procedures, the assessment schedule, and the voluntary nature of participation.
Written informed consent will be obtained from students who agree to participate.
Participants will be informed that they may withdraw from the research at any time.
All collected information will be kept confidential and used only for scientific research purposes.
The intervention is educational and will be conducted using simulation models in a classroom environment. No clinical procedures will be performed on patients as part of the study.
### Expected Contributions and Study Limitations
This study is expected to provide evidence regarding the effectiveness of adding hands-on model-based simulation training to conventional episiotomy education in undergraduate midwifery programs.
The findings may help educators determine whether simulation-based practice improves students' perceived self-efficacy, confidence in learning, and satisfaction with their educational experience.
The study has several limitations. It will be conducted at a single university, which may limit the generalizability of the findings to other educational institutions.
Furthermore, the outcomes will be measured using self-reported questionnaires rather than direct observations of clinical performance. Consequently, improvements in perceived self-efficacy should not be interpreted as confirmed improvements in actual clinical competence.
The follow-up period will be limited to one month, preventing conclusions about the longer-term effects of simulation training.
Despite these limitations, the study may contribute to the development of more effective teaching approaches in midwifery education and support future research on simulation-based clinical skills training.
In the longer term, improvements in midwifery education may contribute to better preparation of future midwives and potentially support the quality of maternity care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is designed as a two-arm, parallel-group, randomized controlled trial. Eligible participants will be randomly assigned to the intervention or control group using computer-generated simple randomization. The control group will receive standard episiotomy education consisting of a presentation and an educational video. The intervention group will receive the same standard education supplemented by hands-on training using episiotomy simulation models. Episiotomy self-efficacy will be assessed at baseline and one month after training, while student satisfaction and self-confidence in learning will be evaluated immediately after training. Following completion of the one-month assessments, control group participants will also be offered hands-on simulation training.
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Other: Model-Based Episiotomy Simulation TrainingParticipants in this group will receive standard episiotomy education consisting of a presentation and an educational video, followed by hands-on training using episiotomy simulation models. Training will be conducted in small groups under the supervision of the researchers. |
| Active Comparator Arm | No intervention | –Participants in this group will receive standard episiotomy education consisting of a presentation and an educational video without initial hands-on simulation training. After completion of the one-month follow-up assessments, participants will also be offered practical training using episiotomy simulation models. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntary agreement to participate in the study
- Ability to speak and understand Turkish
- Age 18 years or older
- Being a third-year undergraduate midwifery student
- Taking the Childbirth Knowledge III course for the first time
Key exclusion criteria (5 listed)
- Not agreeing to participate in the study
- Inability to speak or understand Turkish
- Being younger than 18 years
- Not being a third-year undergraduate midwifery student
- Repeating the Childbirth Knowledge III course due to previous failure or for grade improvement
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-Based Episiotomy Simulation TrainingParticipants will receive hands-on episiotomy training using simulation models in small groups, under the guidance of researchers, in addition to standard education consisting of a presentation and an educational video. | Other | Experimental Arm |
Primary outcome
Change in Episiotomy Self-Efficacy
Time frame: Baseline and one month after the educational intervention
Episiotomy self-efficacy will be assessed using the 17-item Episiotomy Self-Efficacy Scale, which evaluates students' perceived ability to perform episiotomy-related procedures. Total scores range from 17 to 85, with higher scores indicating greater perceived self-efficacy. Changes in scores will be compared between the intervention and control groups.
1 secondary outcome
Student Satisfaction and Self-Confidence in Learning
Time frame: Immediately after the educational intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Pelvic Floor Dysfunction, Perineal Laceration
Recruiting
Impact of Early Physiotherapy on Pain, Quality of Life, Pelvic Floor Function, and Sexual Health Post-Episiotomy
Gynecological; Surgery (Previous), Causing Obstructed Labor
Not yet recruiting
Repeated Pudendal Nerve Block and Physiotherapy for Prevention of Chronic Post-Episiotomy Pain
Chronic Post-episiotomy Pain, Postpartum Dyspareunia
Not yet recruiting
Effect of Mosaic Art on Episiotomy Repair Skills, Anxiety, and Learning Attitudes in Midwifery Students
Education, Nursing
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Model-Based Episiotomy Simulation Training in people with Episiotomy, run by Kırklareli University.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Episiotomy Self-Efficacy (time frame: Baseline and one month after the educational intervention). 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 27 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.