Clinical trial NCT06908278: The Impact of Simulation-Based Education on Midwifery Students' Episiotomy Self-Efficacy Levels
Official title: The Impact of Simulation-Based Education on Midwifery Students' Episiotomy Self-Efficacy Levels: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Episiotomy
Self Efficacy
Simulation Based Medical Education
Lead sponsor: Fenerbahce University
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Self-Efficacy Scores for Episiotomy Repair
timeFrame: Baseline (pre-training), immediately after training, and 4 weeks post-training
Secondary outcomes:
Other outcomes:
Locations:
city: Atasehir
country: Turkey
facility: Fenerbahce University
Study officials:
References: