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Completed

NCT Number: NCT06908278

The Impact of Simulation-Based Education on Midwifery Students' Episiotomy Self-Efficacy Levels

Problem: Self-efficacy, the belief in one's ability to perform tasks, plays a critical role in learning. Inadequate self-efficacy can hinder the development of essential clinical skills in midwifery students.

Background: Simulation-based education provides a safe learning environment that enhances students' skills and confidence without the fear of mistakes. However, the comparative effectiveness of different simulation methods on self-efficacy remains unclear.

Aim: This randomized controlled trial aims to evaluate the effectiveness of suture simulation training versus sponge simulation training on midwifery students' self-efficacy in episiotomy repair. Specifically, it seeks to answer the following questions:

Does suture simulation training improve self-efficacy in episiotomy repair more effectively than sponge simulation training?

What challenges or difficulties do students encounter with each simulation method?

Methods: A total of 84 midwifery students participated in the study. They were randomly assigned to two groups:

Intervention 1 (n=42): Practiced on a suture simulator.

Intervention 2 (n=42): Practiced on a sponge simulator.

Both groups received identical theoretical training on episiotomy repair through slide presentations and video demonstrations over two sessions lasting four hours. Students:

Engaged in hands-on training with their assigned simulation method for four weeks.

Attended clinic visits every two weeks for skill assessments and feedback.

Maintained a self-report diary documenting their confidence levels and skill progression.

Data collection included demographic characteristics, self-efficacy assessments using the Episiotomy Skills Self-Efficacy Scale (ESSES), and observational data. Statistical analyses were planned using t-tests and chi-square tests, with significance set at p<0.05.

Future results will be analyzed and reported separately in the Results Section, following data collection and processing.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fenerbahce University

Ataşehir, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Ability to communicate in Turkish.

Enrollment in the midwifery department.

Registration in courses on midwifery care for high-risk pregnancies and postpartum care following high-risk deliveries.

Exclusion criteria

Inability to communicate in Turkish.

Not enrolled in the midwifery department.

Not registered in the relevant courses.

Any condition preventing participation in hands-on simulation training.

Treatment and study plan

Suture Simulation Training for Episiotomy Repair

Behavioral

This intervention involves training participants to perform episiotomy repairs using a suture simulator. Participants will practice suturing techniques in a controlled, safe environment to improve their self-efficacy in performing the procedure. The training includes both theoretical learning and hands-on practice. The goal is to enhance the participants' confidence and competence in performing episiotomies.

(This description outlines the nature of the intervention and the learning objectives.)

Primary outcomes

  1. Change in Self-Efficacy Scores for Episiotomy Repair

    Time frame: Baseline (pre-training), immediately after training, and 4 weeks post-training

    Self-efficacy in episiotomy repair will be assessed using the Episiotomy Skills Self-Efficacy Scale (ESSES). The ESSES is a validated instrument measuring students' confidence in performing episiotomy repair. Scores range from 0 to 100, with higher scores indicating greater self-efficacy.

Sponsors and collaborators

Lead sponsor

Fenerbahce University

Other

Registry information

Official study title

The Impact of Simulation-Based Education on Midwifery Students' Episiotomy Self-Efficacy Levels: A Randomized Controlled Trial

Acronym: SBE

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 3, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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