EpisiotomySBENCT06908278
The Impact of Simulation-Based Education on Midwifery Students' Episiotomy Self-Efficacy Levels
A study testing Suture Simulation Training for Episiotomy Repair in people with Episiotomy and Self Efficacy, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Episiotomy, Self Efficacy, Simulation Based Medical Education
- What is being tested?
- Suture Simulation Training for Episiotomy Repair
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Apr 2024to 17 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Being tested
- Suture Simulation Training for Episiotomy Repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture Simulation Training for Episiotomy RepairBehavioural
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.)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Suture Simulation Training for Episiotomy Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-training), immediately after training, and 4 weeks post-training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start17 Apr 2024
- Primary completion17 May 2024
- Study completion17 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpisiotomyStudies of the same condition, open and under way.
- More trials run by Fenerbahce UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Ogul, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908278
- Sponsor's protocol ID
- 51.2024fbu
- Acronym
- SBE
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Simulation-Based Education on Midwifery Students' Episiotomy Self-Efficacy Levels: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06908278
- Acronym / sponsor ID
- SBE / 51.2024fbu
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 17 Aug 2024 (actual)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm 1: Suture Simulation Training | Experimental | Behavioral: Suture Simulation Training for Episiotomy RepairParticipants 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. |
| Experimental Arm 2: Sponge Simulation Training | Experimental | Behavioral: Suture Simulation Training for Episiotomy RepairParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suture Simulation Training for Episiotomy RepairThis 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.) | Behavioural | Experimental Arm 1: Suture Simulation Training, Experimental Arm 2: Sponge Simulation Training |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suture Simulation Training for Episiotomy Repair in people with Episiotomy and Self Efficacy, run by Fenerbahce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-Efficacy Scores for Episiotomy Repair (time frame: Baseline (pre-training), immediately after training, and 4 weeks post-training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.