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Hybrid Episiotomy Training and Student Outcomes

6 maggio 2026 aggiornato da: Atlas University

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

51

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Istanbul
      • Istanbul, Istanbul, Turchia (Türkiye), 34408
        • Istanbul Atlas University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Episiotomy Skills Self-Efficacy
Lasso di tempo: Baseline and immediately after training
Scores range from 19 to 76, with higher scores indicating greater self-efficacy in episiotomy repair skills.
Baseline and immediately after training

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Anxiety (STAI)
Lasso di tempo: Baseline and immediately after training
Scores range from 20 to 80 for each subscale, with higher scores indicating higher levels of anxiety.
Baseline and immediately after training
Cognitive Load (DTCLS)
Lasso di tempo: Baseline and immediately after training
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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Ece NİLÜFER, MSc Candidate, Atlas University
  • Direttore dello studio: Meserret ASLAN, PhD Candidate, Atlas University
  • Cattedra di studio: Gülay RATHFISCH, Atlas University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

30 dicembre 2025

Completamento primario (Effettivo)

28 gennaio 2026

Completamento dello studio (Effettivo)

25 febbraio 2026

Date di iscrizione allo studio

Primo inviato

6 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

6 maggio 2026

Primo Inserito (Effettivo)

12 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 maggio 2026

Ultimo verificato

1 gennaio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • E-22686390-050.99-87329

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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