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

NCT06908278 | Completed

• 1 other identifier: 51.2024fbu
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Episiotomy; Self Efficacy; Simulation Based Medical Education

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Experimental Arm 1: Suture Simulation Training

EXPERIMENTAL

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

Experimental Arm 2: Sponge Simulation Training

EXPERIMENTAL

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

Interventions

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.)

Experimental Arm 1: Suture Simulation Training; Experimental Arm 2: Sponge Simulation Training

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fenerbahce University: lead

Study Sites (1)

Fenerbahce University

Ataşehir, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assit. Prof

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 3, 2025
• Study Start: April 17, 2024
• Primary Completion: May 17, 2024
• Study Completion: August 17, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)