Episiotomy Repair TrainingEpisiotomyNCT07923331
Effect of a Novel Episiotomy Repair Simulator on Midwifery Students' Self-Efficacy and Anxiety
A study testing Deney Grubu - Intervention Name and Kontrol Grubu - Intervention Name in people with Episiotomy Repair Training, run by Sakarya University.
Trial summary
This randomized controlled study aims to evaluate the effects of a newly developed episiotomy repair simulator using biological tissue and simulated active bleeding on midwifery students' self-efficacy and anxiety levels. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Episiotomy Repair Training
- What is being tested?
- Deney Grubu - Intervention Name and Kontrol Grubu - Intervention Name
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 19 Nov 2026to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being enrolled in the Midwifery Department at Sakarya University.
- Being enrolled in the Normal Birth and Postpartum Period course during the 2026-2027 fall semester.
- Voluntarily agreeing to participate in the study and providing informed consent.
Who cannot join
- Having previously taken and failed the Normal Birth and Postpartum Period course.
- Being absent from the episiotomy laboratory training session.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Biological Tissue and Active Bleeding-Assisted Episiotomy Repair Simulation on Midwifery Students' Self-Efficacy and Anxiety Levels: A Randomized Controlled Trial
This randomized controlled study aims to evaluate the effects of a newly developed episiotomy repair simulator using biological tissue and simulated active bleeding on midwifery students' self-efficacy and anxiety levels.
Midwifery students enrolled in the Normal Birth and Postpartum Period course at Sakarya University will be randomly assigned to one of two groups. Both groups will receive the same theoretical training on episiotomy and its repair. Students in the intervention group will practice using the newly developed simulator, which provides a restricted working area and simulated active bleeding conditions. Students in the control group will practice using the traditional beef tongue model.
Students' episiotomy self-efficacy and state anxiety levels will be assessed before and after the training using validated measurement tools. The study aims to determine whether the newly developed simulator offers educational benefits compared with the traditional training method.
- Conditions
- Episiotomy Repair Training
- Being tested
- Deney Grubu - Intervention Name, Kontrol Grubu - Intervention Name
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deney Grubu - Intervention NameOther
Biological Tissue and Active Bleeding-Assisted Episiotomy Repair Simulation
Kontrol Grubu - Intervention NameOther
Traditional Beef Tongue Episiotomy Repair Training
| Study group | Role | What they receive |
|---|---|---|
| Biological Tissue and Active Bleeding-Assisted Episiotomy Repair Simulation | Experimental | Participants in this group will receive 50 minutes of theoretical training on episiotomy and its repair, followed by practical training using the newly developed biological tissue and active bleeding-assisted episiotomy repair simulator. The simulator provides a restricted working area, biological tissue for suturing, and simulated active bleeding conditions. Participants will complete self-efficacy and state anxiety assessments before and after the training. Receives: Other: Deney Grubu - Intervention Name |
| Traditional Beef Tongue Episiotomy Training | Active comparator | Participants in this group will receive the same 50-minute theoretical training on episiotomy and its repair, followed by practical training using the traditional beef tongue model routinely used in midwifery education. Each participant will have the opportunity to practice episiotomy and repair techniques under researcher supervision. Self-efficacy and state anxiety will be assessed before and after the training. Receives: Other: Kontrol Grubu - Intervention Name |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Episiotomy Self-Efficacy Scale Score
Episiotomy self-efficacy will be assessed using the Episiotomy Self-Efficacy Scale developed by Yolcu et al. (2025). The scale consists of 17 items across four dimensions: cognitive (5 items), affective (5 items), motivation (3 items), and psychomotor (4 items). Each item is rated on a 5-point Likert scale, with total scores ranging from 17 to 85. Higher scores indicate greater episiotomy self-efficacy. Changes in total scores from before to after training will be compared between the intervention and control groups.
Measured: Immediately before and immediately after the training session (same day).
Change in State Anxiety Inventory (STAI-State) Score
State anxiety will be assessed using the State Anxiety Inventory (STAI-State), which consists of 20 items measuring participants' anxiety at the time of assessment. Total scores range from 20 to 80, with higher scores indicating greater state anxiety. Changes in total scores from before to after training will be compared between the intervention and control groups.
Measured: Immediately before and immediately after the training session (same day).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start19 Nov 2026 (estimated)
- Primary completion10 Dec 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episiotomy Repair TrainingStudies of the same condition, open and under way.
- More trials run by Sakarya 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Hamlaci Baskaya, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923331
- Sponsor's protocol ID
- E-61923333-050.99-640482
- Acronym
- Episiotomy
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to participant confidentiality and data protection considerations. The data collected in this study will be used solely for the purposes of the research and will be securely stored by the research team.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Biological Tissue and Active Bleeding-Assisted Episiotomy Repair Simulation on Midwifery Students' Self-Efficacy and Anxiety Levels: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07923331
- Acronym / sponsor ID
- Episiotomy / E-61923333-050.99-640482
- Conditions
- Episiotomy Repair Training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 19 Nov 2026 (estimated)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 6 Nov 2026 (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.
This randomized controlled study aims to evaluate the effects of a newly developed episiotomy repair simulator using biological tissue and simulated active bleeding on midwifery students' self-efficacy and anxiety levels.
Midwifery students enrolled in the Normal Birth and Postpartum Period course at Sakarya University will be randomly assigned to one of two groups. Both groups will receive the same theoretical training on episiotomy and its repair. Students in the intervention group will practice using the newly developed simulator, which provides a restricted working area and simulated active bleeding conditions. Students in the control group will practice using the traditional beef tongue model.
Students' episiotomy self-efficacy and state anxiety levels will be assessed before and after the training using validated measurement tools. The study aims to determine whether the newly developed simulator offers educational benefits compared with the traditional training method.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biological Tissue and Active Bleeding-Assisted Episiotomy Repair Simulation | Experimental | Other: Deney Grubu - Intervention NameParticipants in this group will receive 50 minutes of theoretical training on episiotomy and its repair, followed by practical training using the newly developed biological tissue and active bleeding-assisted episiotomy repair simulator. The simulator provides a restricted working area, biological tissue for suturing, and simulated active bleeding conditions. Participants will complete self-efficacy and state anxiety assessments before and after the training. |
| Traditional Beef Tongue Episiotomy Training | Active comparator | Other: Kontrol Grubu - Intervention NameParticipants in this group will receive the same 50-minute theoretical training on episiotomy and its repair, followed by practical training using the traditional beef tongue model routinely used in midwifery education. Each participant will have the opportunity to practice episiotomy and repair techniques under researcher supervision. Self-efficacy and state anxiety will be assessed before and after the training. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being enrolled in the Midwifery Department at Sakarya University.
- Being enrolled in the Normal Birth and Postpartum Period course during the 2026-2027 fall semester.
- Voluntarily agreeing to participate in the study and providing informed consent.
Key exclusion criteria (2 listed)
- Having previously taken and failed the Normal Birth and Postpartum Period course.
- Being absent from the episiotomy laboratory training session.
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 |
|---|---|---|
| Deney Grubu - Intervention NameBiological Tissue and Active Bleeding-Assisted Episiotomy Repair Simulation | Other | Biological Tissue and Active Bleeding-Assisted Episiotomy Repair Simulation |
| Kontrol Grubu - Intervention NameTraditional Beef Tongue Episiotomy Repair Training | Other | Traditional Beef Tongue Episiotomy Training |
Primary outcome
Change in Episiotomy Self-Efficacy Scale Score
Time frame: Immediately before and immediately after the training session (same day).
Episiotomy self-efficacy will be assessed using the Episiotomy Self-Efficacy Scale developed by Yolcu et al. (2025). The scale consists of 17 items across four dimensions: cognitive (5 items), affective (5 items), motivation (3 items), and psychomotor (4 items). Each item is rated on a 5-point Likert scale, with total scores ranging from 17 to 85. Higher scores indicate greater episiotomy self-efficacy. Changes in total scores from before to after training will be compared between the intervention and control groups.
Change in State Anxiety Inventory (STAI-State) Score
Time frame: Immediately before and immediately after the training session (same day).
State anxiety will be assessed using the State Anxiety Inventory (STAI-State), which consists of 20 items measuring participants' anxiety at the time of assessment. Total scores range from 20 to 80, with higher scores indicating greater state anxiety. Changes in total scores from before to after training will be compared between the intervention and control groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to participant confidentiality and data protection considerations. The data collected in this study will be used solely for the purposes of the research and will be securely stored by the research team.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Deney Grubu - Intervention Name and Kontrol Grubu - Intervention Name in people with Episiotomy Repair Training, run by Sakarya University.
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 2 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: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Busra Y Yolcu, PhD (05350364594, busrayolcu@sakarya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Episiotomy Self-Efficacy Scale Score (time frame: Immediately before and immediately after the training session (same day).). The study lists 2 primary outcomes in all. 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 6 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.