An interventional study of Deney Grubu - Intervention Name and Kontrol Grubu - Intervention Name in Episiotomy Repair Training, sponsored by Sakarya University. Not yet recruiting. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Sakarya University · Not applicable, Interventional, and Other
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.
Sakarya University is the lead sponsor of 190 studies on the registry; 53 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Deney Grubu - Intervention Name
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.
Other: Kontrol Grubu - Intervention Name
Biological Tissue and Active Bleeding-Assisted Episiotomy Repair Simulation
Traditional Beef Tongue Episiotomy Repair Training
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.
Time frame: 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.
Time frame: Immediately before and immediately after the training session (same day).
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2026, 0 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.