Episiotomy
The Effectiveness of Episiotomy Training Using Model-Based Simulation: A Randomized Controlled Study
Sponsor study identifier
interventional
90
0 countries
N/A
Study Start
October 19, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 19, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 20, 2026
Actual (reported)October 27, 2026
Actual (reported)November 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Baseline and one month after the educational intervention
Student Satisfaction and Self-Confidence in Learning
Immediately after the educational intervention
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.
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.
First Submitted
October 20, 2026
First Posted
October 27, 2026
Contact the study team to confirm eligibility.
Study Start
October 19, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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