- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07582302
Hybrid Episiotomy Training and Student Outcomes
Effects of a Hybrid Episiotomy Repair Training Model on Midwifery Students' Self-Efficacy, Anxiety and Cognitive Load
The goal of this clinical trial is to evaluate the effects of a hybrid episiotomy repair training model on self-efficacy, anxiety, and cognitive load in third-year midwifery students. The main questions it aims to answer are:
Does standardized sponge-based training improve students' episiotomy skills self-efficacy and cognitive load? Is there a difference between chicken tissue-based training and virtual reality-based training in terms of self-efficacy, anxiety, and cognitive load outcomes?
Researchers will compare chicken tissue-based training and virtual reality-based training to determine whether there are differences in educational outcomes between these two advanced simulation methods.
Participants will:
- complete baseline assessments of anxiety, self-efficacy, and cognitive load,
- receive standardized episiotomy repair training using a sponge model,
- be randomly assigned to either chicken tissue-based hands-on training or virtual reality-based video training,
- complete post-training assessments following each training phase.
Studienübersicht
Status
Detaillierte Beschreibung
This study is a randomized comparative educational intervention designed to evaluate the effects of a hybrid episiotomy repair training model on midwifery students' self-efficacy, anxiety levels, and cognitive load. Episiotomy repair is a technically demanding clinical skill that is difficult to practice in real clinical settings due to its invasive nature and limited opportunities for hands-on experience. Therefore, simulation-based training methods are essential to support skill acquisition in a safe and controlled learning environment.
The study was conducted with third-year midwifery students enrolled in the Department of Midwifery at Istanbul Atlas University during the 2025-2026 academic year. A total of 51 students who met the inclusion criteria and provided informed consent participated in the study. All participants first received standardized theoretical and practical training on episiotomy repair using sponge models to establish baseline psychomotor competence.
Following this initial phase, participants were randomly assigned in a 1:1 ratio to one of two advanced training groups using a computer-generated randomization sequence. The first group received hands-on training using chicken tissue, which provides a more realistic tactile simulation of human perineal tissue. The second group received non-interactive virtual reality-based video training, designed to enhance cognitive and visual understanding of the episiotomy repair procedure.
Data were collected at three time points: before the training (baseline), after the standardized sponge-based training, and after completion of the assigned advanced training intervention. The primary outcomes included episiotomy skills self-efficacy, anxiety levels, and cognitive load. Self-efficacy was assessed using the Episiotomy Skills Self-Efficacy Scale (ESSES), anxiety levels were measured using the State-Trait Anxiety Inventory (STAI), and cognitive load was evaluated using the Different Types of Cognitive Load Scale (DTCLS).
The study aims to determine whether standardized sponge-based training improves students' learning outcomes and to compare the effectiveness of chicken tissue-based training and virtual reality-based training in reinforcing these outcomes. The findings are expected to contribute to the development of evidence-based educational strategies in midwifery education by identifying effective and feasible simulation-based training models for teaching episiotomy repair skills.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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-
Istanbul
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Istanbul, Istanbul, Türkei (türkiye), 34408
- Istanbul Atlas University
-
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Being a third-year midwifery student
- Having completed theoretical education on episiotomy and perineal repair
- Voluntary agreement to participate in the study
- Providing written informed consent
Exclusion Criteria:
- Having previously performed episiotomy repair actively in a clinical setting
- Having any physical condition that may affect surgical hand skills
- Not attending any of the training sessions during the study
- Not completing the data collection process
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Chicken Tissue-Based Episiotomy Repair Training
Participants in this arm received standardized episiotomy repair training using sponge models, followed by hands-on episiotomy repair practice on chicken tissue under instructor supervision.
Final assessments of self-efficacy, anxiety, and cognitive load were conducted after completion of the training.
|
Standardized theoretical and practical training on episiotomy repair using sponge models to establish baseline psychomotor skills.
Hands-on episiotomy repair training using chicken tissue to provide realistic tactile practice under instructor supervision.
|
|
Experimental: Virtual Reality-Based Episiotomy Repair Training
Participants in this arm received standardized episiotomy repair training using sponge models, followed by non-interactive virtual reality-based video training demonstrating episiotomy repair procedures.
Final assessments of self-efficacy, anxiety, and cognitive load were conducted after completion of the training.
|
Standardized theoretical and practical training on episiotomy repair using sponge models to establish baseline psychomotor skills.
Non-interactive virtual reality-based video training demonstrating episiotomy repair procedures to support cognitive and visual learning.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Episiotomy Skills Self-Efficacy
Zeitfenster: Baseline and immediately after training
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Scores range from 19 to 76, with higher scores indicating greater self-efficacy in episiotomy repair skills.
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Baseline and immediately after training
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Anxiety (STAI)
Zeitfenster: Baseline and immediately after training
|
Scores range from 20 to 80 for each subscale, with higher scores indicating higher levels of anxiety.
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Baseline and immediately after training
|
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Cognitive Load (DTCLS)
Zeitfenster: Baseline and immediately after training
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The scale assesses intrinsic, extraneous, and germane cognitive load using a Likert-type format, with higher scores indicating higher perceived cognitive load.
|
Baseline and immediately after training
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Ece NİLÜFER, MSc Candidate, Atlas University
- Studienleiter: Meserret ASLAN, PhD Candidate, Atlas University
- Studienstuhl: Gülay RATHFISCH, Atlas University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- E-22686390-050.99-87329
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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