- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Descrição detalhada
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 de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Istanbul
-
Istanbul, Istanbul, Turquia (Türkiye), 34408
- Istanbul Atlas University
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Episiotomy Skills Self-Efficacy
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Anxiety (STAI)
Prazo: 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)
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ece NİLÜFER, MSc Candidate, Atlas University
- Diretor de estudo: Meserret ASLAN, PhD Candidate, Atlas University
- Cadeira de estudo: Gülay RATHFISCH, Atlas University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- E-22686390-050.99-87329
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .