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Effect of Simulation-Based Education on Knowledge, Skills, and Self-Efficacy in Postpartum Hemorrhage Management

29 de mayo de 2026 actualizado por: Ömercan Aksoy

Effect of Simulation-Based Education on Knowledge, Skills, and Self-Efficacy in Postpartum Hemorrhage Management: A Randomized Controlled Trial

Postpartum hemorrhage is an important obstetric emergency that requires early recognition and timely management. Midwifery students may have limited opportunities to practise postpartum hemorrhage management repeatedly in real clinical settings. Simulation-based education may help students practise assessment, decision-making, emergency interventions, communication, and documentation in a safe learning environment.

This study evaluated the effect of simulation-based education on third-year midwifery students' knowledge, postpartum hemorrhage management skill performance, and self-efficacy. Participants were randomly assigned to either an intervention group or a control group. Both groups received traditional theoretical education on postpartum hemorrhage management. The intervention group additionally received simulation-based postpartum hemorrhage management education using a high-fidelity birthing simulator.

Knowledge and self-efficacy were assessed before the intervention, immediately after the intervention, and four weeks later. Skill performance was assessed immediately after the intervention and again four weeks later using a structured skills checklist. The study aimed to determine whether simulation-based education improved students' learning outcomes compared with traditional theoretical education alone.

Descripción general del estudio

Descripción detallada

This randomized controlled study was designed to evaluate the effect of simulation-based education on midwifery students' learning outcomes in postpartum hemorrhage management. The study was conducted with third-year undergraduate midwifery students at a university in Istanbul, Türkiye.

Eligible participants were third-year midwifery students who had completed the Normal Birth and Midwifery Care course and were enrolled in the High-Risk Birth and Midwifery Care course during the 2022-2023 academic year. Students who agreed to participate were randomly assigned to an intervention group or a control group.

All participants first received traditional theoretical education on postpartum hemorrhage management. The theoretical education included the definition, importance, etiology, risk factors, prevention, treatment, and management of postpartum hemorrhage. The intervention group then received additional simulation-based postpartum hemorrhage management education. The simulation session was conducted in a simulation laboratory arranged as a postpartum patient room and used a high-fidelity birthing simulator. The simulation included prebriefing, a postpartum hemorrhage scenario, and debriefing. Moulage and clinical equipment were used to support scenario realism.

The control group received traditional theoretical education only and did not participate in the simulation-based education session. Participants in both groups completed the same outcome assessments.

The primary learning outcomes were postpartum hemorrhage management knowledge, skill performance, and self-efficacy. Knowledge was measured using the Postpartum Hemorrhage Management Knowledge Test. Self-efficacy was measured using the Postpartum Hemorrhage Management Self-Efficacy Form. Skill performance was assessed using the Postpartum Hemorrhage Management Skills Checklist by external observers.

Knowledge and self-efficacy were measured at three time points: baseline, immediately after the intervention, and four weeks after the intervention. Skill performance was assessed immediately after the intervention and at the four-week follow-up. The study compared changes in these outcomes between the intervention and control groups to determine whether simulation-based education provided additional benefit beyond traditional theoretical education.

Tipo de estudio

Intervencionista

Inscripción (Actual)

45

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Descripción

Inclusion Criteria:

  • Third-year undergraduate midwifery students enrolled in the Department of Midwifery during the 2022-2023 academic year
  • Completion of the Normal Birth and Midwifery Care course
  • Enrollment in the High-Risk Birth and Midwifery Care course during the study period
  • Voluntary agreement to participate in the study
  • Ability to attend all study sessions and follow-up assessments

Exclusion Criteria:

  • Previous participation in structured postpartum hemorrhage simulation-based training
  • Absence from any part of the educational intervention or outcome assessments
  • Withdrawal of consent during the study period

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Simulation-Based PPH Management Education Group
Participants in this arm received traditional theoretical education on postpartum hemorrhage management followed by simulation-based postpartum hemorrhage management education using a high-fidelity birthing simulator. The simulation session included prebriefing, a postpartum hemorrhage scenario, and debriefing.
Simulation-based education was delivered using a high-fidelity birthing simulator in a simulation laboratory arranged as a postpartum patient room. The session included a 5-minute prebriefing, a 15-minute postpartum hemorrhage management scenario, and a 30-minute debriefing. The scenario required learners to assess vital signs, lochia, fundus, pain, and IV catheter status; recognize postpartum hemorrhage; communicate using SBAR; initiate emergency interventions; and document care.Simulation-based education was delivered using a high-fidelity birthing simulator in a simulation laboratory arranged as a postpartum patient room. The session included a 5-minute prebriefing, a 15-minute postpartum hemorrhage management scenario, and a 30-minute debriefing. The scenario required learners to assess vital signs, lochia, fundus, pain, and IV catheter status; recognize postpartum hemorrhage; communicate using SBAR; initiate emergency interventions; and document care.
Otros nombres:
  • Simulation-based PPH management education
Traditional theoretical education was delivered face-to-face in a classroom setting and lasted approximately one hour. The session covered the definition, importance, etiology, risk factors, prevention, treatment, and management of postpartum hemorrhage. The education was supported by a PowerPoint presentation and included lecture, question-answer, discussion, and brainstorming methods.
Otros nombres:
  • Traditional theoretical PPH education
Comparador activo: Traditional Theoretical PPH Education Group
Participants in this arm received traditional theoretical education on postpartum hemorrhage management only. They did not receive simulation-based education during the study period.
Traditional theoretical education was delivered face-to-face in a classroom setting and lasted approximately one hour. The session covered the definition, importance, etiology, risk factors, prevention, treatment, and management of postpartum hemorrhage. The education was supported by a PowerPoint presentation and included lecture, question-answer, discussion, and brainstorming methods.
Otros nombres:
  • Traditional theoretical PPH education

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
PPH Management Skill Performance Score
Periodo de tiempo: Post-intervention and four-week follow-up
PPH management skill performance was assessed using the Postpartum Hemorrhage Management Skills Checklist. The checklist includes 23 items scored as 0 = needs improvement, 1 = partially adequate, and 2 = adequate. Total scores range from 0 to 46, with higher scores indicating better PPH management skill performance.PPH management skill performance was assessed using the Postpartum Hemorrhage Management Skills Checklist. The checklist includes 23 items scored as 0 = needs improvement, 1 = partially adequate, and 2 = adequate. Total scores range from 0 to 46, with higher scores indicating better PPH management skill performance.
Post-intervention and four-week follow-up

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
PPH Management Knowledge Score
Periodo de tiempo: Baseline, post-intervention, and four-week follow-up
PPH management knowledge was assessed using the Postpartum Hemorrhage Management Knowledge Test. The test includes 23 items scored as 0 = incorrect and 1 = correct. Total scores range from 0 to 23, with higher scores indicating higher knowledge of PPH management.
Baseline, post-intervention, and four-week follow-up
PPH Management Self-Efficacy Score
Periodo de tiempo: Baseline, post-intervention, and four-week follow-up
PPH management self-efficacy was assessed using the Postpartum Hemorrhage Management Self-Efficacy Form. The form includes 13 items rated on a five-point Likert scale. Total scores range from 13 to 65, with higher scores indicating higher perceived self-efficacy in PPH management.
Baseline, post-intervention, and four-week follow-up

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de mayo de 2023

Finalización primaria (Actual)

15 de junio de 2023

Finalización del estudio (Actual)

15 de junio de 2023

Fechas de registro del estudio

Enviado por primera vez

24 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

24 de mayo de 2026

Publicado por primera vez (Actual)

1 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data will not be shared because participant consent did not include permission for sharing de-identified individual-level data outside the primary research group.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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