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NCT06908278: SBE
The Impact of Simulation-Based Education on Midwifery Students' Episiotomy Self-Efficacy Levels
NA trial testing Suture Simulation Training for Episiotomy Repair in Episiotomy in 84 participants. Completed in 17 August 2024.
17 May 2024
Quick facts
| Lead sponsor | Fenerbahce University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 84 |
| Start date | 17 April 2024 |
| Primary completion | 17 May 2024 |
| Estimated completion | 17 August 2024 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Suture Simulation Training for Episiotomy Repair
Conditions studied
- Episiotomy — all drugs for Episiotomy →
- Self Efficacy — all drugs for Self Efficacy →
- Simulation Based Medical Education — all drugs for Simulation Based Medical Education →
Sponsor
Fenerbahce University
Who can join
18 and older, female only, with Episiotomy or Self Efficacy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06908278
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06908278 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fenerbahce University
- Last refreshed: 9 April 2025
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