Comparing Simulated Patients and Manikin Based Simulation in Obstetrics
Effect of Manikin and Simulated-Patient Realism on Training Experience and Performance in Emergency Team Training: A Mixed-Methods Research Programme: Substudy C - Simulated Patient vs. MamaAnne for PPH and Eclampsia Team Training
The aim of this randomized study is to compare a live, trained simulated patient with a high-fidelity manikin in obstetric emergency team training using two standardized scenarios. The participants in this study are intact clinical teams (e.g., obstetrics, anesthesiology, and nursing/midwifery staff routinely working together in obstetric emergencies) and are recruited as a unit. Each team will either have both scenarios with the live, trained standard patient or the high fidelity manikin. Both scenarios are standardized: One scenario is about post-partum hemorrhage (PPH), a severe bleeding after giving birth, and the other scenario is about eclampsia, an emergency in obstetrics that causes hypertensive crisis and seizures. The order of scenarios is random. After each scenario all team members fill out questionnaires about realism and cognitive stress. After the second debriefing, a focus group of approximately 15 minutes is conducted with each team with a standardized procedure and questions.
Descripción general del estudio
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Intervención / Tratamiento
Descripción detallada
The focus group is led by a moderator who did not facilitate either debriefing and who holds no supervisory relationship to any participant. A short semi-structured guide of five questions is used. The focus group is a separate element of the study and is not one of the two debriefings; it begins only once the second debriefing has been formally closed.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mathias Maleczek, PD Dr.
- Número de teléfono: +4314040041020
- Correo electrónico: mathias.maleczek@meduniwien.ac.at
Copia de seguridad de contactos de estudio
- Nombre: Florian Berger, Dr.
- Número de teléfono: +4314040041020
- Correo electrónico: florian.berger@meduniwien.ac.at
Ubicaciones de estudio
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State of Vienna
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Vienna, State of Vienna, Austria, 1090
- Medical University of Vienna
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Contacto:
- Mathias Maleczek, PD Dr.
- Número de teléfono: +4314040041020
- Correo electrónico: mathias.maleczek@meduniwien.ac.at
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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:
- Individual inclusion criteria are: physician, midwife, registered nurse, or paramedic; current clinical duties in obstetric or peripartum emergency care
- written informed consent
Exclusion Criteria:
- Pregnancy
- Exclusion criteria are pregnancy and prior participation in a simulation study using the same obstetric scenarios.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Trained Simulated Patient
Both scenarios portrayed by a trained Simulated Patient (PPH: verbalized pain/distress, simulated blood loss via MamaNatalie; eclampsia: seizure activity, verbal responses where clinically appropriate, hypertensive crisis presentation). |
Trained, standardized patient portraying obstetric woman with MamaNatalie simulator
Otros nombres:
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Experimental: High-fidelity Manikin
Both scenarios portrayed by a high fidelity obstetric manikin (PPH: verbalized pain/distress, simulated blood loss via MamaAnne; eclampsia: seizure activity, verbal responses where clinically appropriate, hypertensive crisis presentation). |
Patient portrayed by high fidelity obstetric manikin MamaAnne |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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SRS-Score
Periodo de tiempo: Immediately after each scenario (scenario 1 and scenario 2, on the day of training)
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Perceived realism of the simulation measured with the Simulation Realism Scale (SRS), completed individually by every team member after each of the two scenarios. Score range [min] to [max]; higher scores indicate greater perceived realism. |
Immediately after each scenario (scenario 1 and scenario 2, on the day of training)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Perceived realism on a Numeric Rating Scale (NRS)
Periodo de tiempo: Immediately after each scenario (scenario 1 and scenario 2, on the day of training)
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Single-item perceived realism rated on a Numeric Rating Scale (NRS) from 0 (not realistic at all) to 10 (completely realistic); higher scores indicate greater perceived realism. Completed individually by every team member after each scenario. |
Immediately after each scenario (scenario 1 and scenario 2, on the day of training)
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Themes on perceived realism and training experience (reflexive thematic analysis of focus groups)
Periodo de tiempo: Immediately after the debriefing of the second scenario, on the day of training
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Debriefing and focus group transcripts are analyzed together using reflexive thematic analysis. Two researchers code independently; a codebook is developed after the first four teams and applied to the remainder, with discrepancies resolved in consensus discussion and a third researcher consulted where consensus is not reached. Coders are not blinded to modality, since modality is evident from the transcript; this is reported as a limitation. Analytic adequacy is judged against information power rather than data saturation, taking into account the narrow study aim, the high specificity of the sample, and the use of an established theoretical frame. |
Immediately after the debriefing of the second scenario, on the day of training
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
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Finalización del estudio (Estimado)
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Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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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
- Enfermedades urogenitales
- Procesos Patológicos
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Complicaciones obstétricas del parto
- Complicaciones del embarazo
- Hemorragia
- Hipertensión, inducida por el embarazo
- Trastornos Puerperales
- Hemorragia uterina
- Condiciones Patológicas, Signos y Síntomas
- Eclampsia
- Hemorragia post parto
Otros números de identificación del estudio
- Fidelity C
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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