Brief Title: Portable 3D Visual Material-Supported Simulation Training for Cervical Dilation Assessment
14 de julho de 2026 atualizado por: Ayşegül Şimşek, Marmara University
Accessible Simulation Approaches: The Effect of Portable Three-Dimensional Visual Material-Supported Education on University Students' Knowledge, Satisfaction, and Self-Confidence
This randomized controlled trial aimed to evaluate the effectiveness of simulation-based education supported by a portable and mobile three-dimensional (3D) visual material on university students' knowledge of cervical dilation assessment, learning satisfaction, self-confidence in learning, and perceptions of simulation design.
Undergraduate health sciences students were randomly assigned to either an intervention group receiving simulation training with the portable 3D material in addition to standard education or a control group receiving standard education alone.
The primary outcome was change in knowledge of cervical dilation assessment.
Secondary outcomes included student satisfaction, self-confidence in learning, and perceptions of simulation design.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
This study is a parallel-group, 1:1 allocation randomized controlled trial with a pretest-posttest design conducted among third-year undergraduate health sciences students enrolled in the Pregnancy and Care course. Participants were randomly assigned using a computer-generated randomization sequence with allocation concealment through sequentially numbered opaque sealed envelopes.
Both groups received the standard theoretical and laboratory curriculum on cervical dilation assessment. In addition, participants allocated to the intervention group received simulation-based training supported by a portable and foldable three-dimensional cervical dilation educational model designed to facilitate repeated individual practice outside the simulation laboratory. Students practiced with the model seven times throughout the semester using a standardized educational protocol delivered by the same instructor.
The educational material was specifically developed to provide an accessible, reusable, and portable simulation resource that allows repeated psychomotor practice without requiring permanent simulation laboratory access. The study evaluated whether supplementing standard education with repeated practice using the portable three-dimensional model improves educational outcomes compared with standard education alone. The trial was conducted in accordance with the CONSORT reporting guideline, and no protocol modifications were made after trial initiation. Ethical approval and written informed consent were obtained before participant enrollment.
Tipo de estudo
Intervencional
Inscrição (Real)
62
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Istanbul, Turquia (Türkiye), 34854
- Marmara University, Faculty of Health Sciences
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
Inclusion Criteria:
- Undergraduate student enrolled in the Faculty of Health Sciences
- Enrolled in the Pregnancy and Care course during the study period
- Aged 18 years or older
- Provided written informed consent
Exclusion Criteria:
- Did not participate in any stage of the educational intervention
- Did not complete the post-intervention assessments
- Did not complete the study questionnaires
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Intervention Group
Participants received the standard theoretical and laboratory education plus simulation-based training supported by a portable and mobile three-dimensional visual cervical dilation educational material.
Students practiced with the portable material once every two weeks throughout the semester.
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Simulation-based education supported by a portable and mobile three-dimensional visual educational material designed for cervical dilation assessment.
Participants practiced with the material repeatedly throughout the semester in addition to standard education.
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Comparador Ativo: Control Group
Participants received the standard theoretical instruction and laboratory education on cervical dilation assessment without the portable three-dimensional educational material.
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Standard theoretical instruction and laboratory training on cervical dilation assessment delivered as part of the regular curriculum.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Cervical Dilatation Assessment Knowledge Test (CDAK) Score
Prazo: Immediately after completion of the 14-week intervention
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Change in knowledge regarding cervical dilation assessment measured using the Cervical Dilatation Assessment Knowledge Test (CDAK).
Developed by the researchers in accordance with the literature.
To assess the test's content validity, it was submitted for review to 10 experts in the field, including academics and healthcare professionals (physicians, midwives, and nurses).
In the test, each correct answer was scored as 1 point, and each incorrect answer as 0 points.
The experts were asked to evaluate the items using a three-point rating scale (1 = Necessary, 2 = Useful but not necessary, 3 = Unnecessary) based on the Lawshe technique.
In addition, experts who selected the "Should be corrected" option were asked to provide suggestions for corrections to the relevant item, while those who selected the "Should be removed" option were asked to provide their reasons for removal.
As a result of the Lawshe technique, the content validity ratio (CVR) was found to be 0.79 (p<0.05).
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Immediately after completion of the 14-week intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Student Satisfaction and Self-Confidence in Learning
Prazo: Immediately after completion of the 14-week intervention
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Student satisfaction measured using the Student Satisfaction and Self-Confidence in Learning Scale (Satisfaction subscale).
Higher scores indicate greater satisfaction with learning.
Scale was developed in 2006 and adapted into Turkish in 2017.
The scale consists of 12 items and 2 subscales (Satisfaction with current learning = 5 items, Self-confidence in learning = 7 items).
The scale is a five-point Likert type with no reverse-scored items (1 = Strongly Disagree; 5 = Strongly Agree).
The total SSSS score is obtained by dividing the sum of the subscale scores by the number of items.
Higher scores indicate higher satisfaction and self-confidence.
The total Cronbach Alpha value of the scale is reported as 0.95, and in our study, it was found to be 0.95 immediately after the training and 0.95 14 weeks after the training.
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Immediately after completion of the 14-week intervention
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Simulation Design Perception
Prazo: Immediately after completion of the 14-week intervention
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Students' perceptions of simulation design measured using the Simulation Design Scale (SDS).
Higher scores indicate more positive evaluations of the simulation design.
Scale, developed in 2006 and adapted into Turkish in 2017.
The scale consists of 20 items and 5 subscales (Goals and information=5 items, Support=4 items, Problem Solving=5 items, Feedback=4 items, and Realism=2 items).
The scale is evaluated in two sections.
The first section assesses whether the best simulation design elements are applied in the simulation application.
The second section evaluates the degree to which simulation design elements are important for students.
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Immediately after completion of the 14-week intervention
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Aysegul Simsek, PhD, Marmara University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
22 de janeiro de 2024
Conclusão Primária (Real)
14 de junho de 2024
Conclusão do estudo (Real)
14 de junho de 2024
Datas de inscrição no estudo
Enviado pela primeira vez
10 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de julho de 2026
Primeira postagem (Real)
15 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
16 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- ISTUNIV-CDA-3D-2024
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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