- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07854106
Hybrid Simulation in Postpartum Hemorrhage Training for Nursing Students
The Effect of Hybrid Simulation-Based Postpartum Hemorrhage Management Training on Nursing Students' Satisfaction, Self-Confidence, and Clinical Readiness in Women's Health Nursing Education: A Randomized Controlled Trial
Abstract Postpartum hemorrhage (PPH) is a leading cause of maternal mortality and morbidity worldwide, requiring nursing students to acquire both theoretical knowledge and clinical competence for safe and effective management. Hybrid simulation, integrating standardized patients with high-fidelity simulators, is an innovative educational approach that simultaneously enhances communication and psychomotor skills.
This prospective randomized controlled study aims to evaluate the effects of a hybrid simulation-based postpartum hemorrhage management training on nursing students' learning satisfaction, self-confidence, and clinical readiness.
The study was conducted with third-year nursing students at Eskisehir Osmangazi University Faculty of Health Sciences, Department of Nursing. Participants were randomly assigned to either an intervention group receiving hybrid simulation-based training using standardized patients and a birthing simulator, or a control group receiving routine education.
Data were collected before and after the intervention using a Personal Information Form, the Student Satisfaction and Self-Confidence in Learning Scale, and the Nursing Clinical Readiness Scale to evaluate outcomes between the groups.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Eyalet/İl Seçin
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Eskişehir, Eyalet/İl Seçin, Turquía (Türkiye)
- Eskisehir Osmangazi University Faculty of Health Sciences
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Being an undergraduate nursing student at Eskisehir Osmangazi University Faculty of Health Sciences
- Being a third-year student enrolled in the Women's Health and Diseases Nursing course for the first time
- Volunteering to participate and providing written informed consent
- Not having previously received structured simulation training on postpartum hemorrhage management
- Having no physical, cognitive, or psychiatric health conditions that impair communication
Exclusion Criteria:
- Incomplete completion of data collection instruments
- Non-attendance at pre-test or post-test assessments
- Failure to complete the assigned educational intervention
- Withdrawal of consent or voluntary withdrawal at any stage of the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention Group
Nursing students receiving hybrid simulation-based postpartum hemorrhage (PPH) management training. |
Students receive interactive hybrid simulation-based training combining standardized patients and task trainers focused on postpartum hemorrhage management skills, clinical decision-making, and team communication. |
|
Comparador activo: Control Group
Nursing students receiving standard postpartum hemorrhage management education. |
Students receive traditional curriculum-based theoretical education and standard lecture-based instruction on postpartum hemorrhage management. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Readiness for Nursing Practice Scale
Periodo de tiempo: Baseline and immediately post-intervention
|
Assessed using the Turkish version of the Nursing Clinical Readiness Scale (originally developed by Kim and Shin, 2022; Turkish validation by Kavuran et al., 2023) to evaluate nursing students' clinical readiness in managing postpartum hemorrhage. The scale consists of 35 items rated on a 10-point Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree). Total scores range from 35 to 350 (or mean item scores from 1 to 10), where higher scores indicate a higher level of clinical readiness. |
Baseline and immediately post-intervention
|
|
Student Satisfaction and Self-Confidence in Learning Scale
Periodo de tiempo: Baseline and immediately post-intervention
|
Assessed using the Turkish version of the Student Satisfaction and Self-Confidence in Learning Scale (originally developed by Jeffries and Rizzolo, 2006; Turkish validation by Unver et al., 2017). The scale consists of 12 items across two subscales: Satisfaction with Current Learning (5 items) and Self-Confidence in Learning (7 items), rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Scores are calculated by dividing the sum of scores by the number of items, with mean scores ranging from 1 to 5 (total score range: 12 to 60), where higher scores indicate higher levels of student satisfaction and self-confidence in learning. |
Baseline and immediately post-intervention
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UludagU-SHMYO-MU-02
- 2025-SBB-1124 (Otro identificador: Bartın University Social and Human Sciences Ethics Committee)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Individual participant data will not be shared publicly to protect participant confidentiality. De-identified data may be made available from the corresponding author upon reasonable request.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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