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

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

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.

Study Overview

• Status: Completed
• Conditions: Self Efficacy; Episiotomy; Simulation Based Medical Education
• Intervention / Treatment: Behavioral: Suture Simulation Training for Episiotomy Repair

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Atasehir, Turkey
    • Fenerbahçe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm 1: Suture Simulation Training; Participants in this arm will receive suture simulation training for episiotomy repair. This includes both theoretical instruction and hands-on practice using a suture simulator in a controlled, guided setting. The purpose of this intervention is to enhance self-efficacy and competence in episiotomy suturing.	Behavioral: Suture Simulation Training for Episiotomy Repair; 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.)
Experimental: Experimental Arm 2: Sponge Simulation Training; Participants in this arm will receive sponge simulation training for episiotomy repair. The training includes theoretical education followed by hands-on practice using sponge materials that mimic soft tissue. The goal is to develop suturing skills and improve participants' self-efficacy in performing episiotomy repairs in a safe and controlled environment.	Behavioral: Suture Simulation Training for Episiotomy Repair; 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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Self-Efficacy Scores for Episiotomy Repair	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.	Baseline (pre-training), immediately after training, and 4 weeks post-training

Collaborators and Investigators

• Sponsor: Fenerbahce University

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2024
• Primary Completion (Actual): May 17, 2024
• Study Completion (Actual): August 17, 2024

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): April 3, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 51.2024fbu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: ogul.zeynep.ogul

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No