An interventional study of Model-Based Episiotomy Simulation Training in Episiotomy, sponsored by Kırklareli University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Kırklareli University · Not applicable, Interventional, and Other
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.
### 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.
Kırklareli University is the lead sponsor of 49 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
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.
Other: Model-Based Episiotomy Simulation Training
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.
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.
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.
Time frame: Baseline and one month after the educational intervention
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.
Time frame: Immediately after the educational intervention
No study locations are listed for this record.
Start is estimated for Oct 2026; primary completion for Nov 2026, 1 month later.
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