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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Mathias Maleczek, PD Dr.
- Numero di telefono: +4314040041020
- Email: mathias.maleczek@meduniwien.ac.at
Backup dei contatti dello studio
- Nome: Florian Berger, Dr.
- Numero di telefono: +4314040041020
- Email: florian.berger@meduniwien.ac.at
Luoghi di studio
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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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Contatto:
- Mathias Maleczek, PD Dr.
- Numero di telefono: +4314040041020
- Email: mathias.maleczek@meduniwien.ac.at
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: 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
Altri nomi:
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Sperimentale: 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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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SRS-Score
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Perceived realism on a Numeric Rating Scale (NRS)
Lasso di tempo: 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)
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Processi patologici
- Malattie urogenitali femminili e complicanze della gravidanza
- Complicanze ostetriche del lavoro
- Complicazioni della gravidanza
- Emorragia
- Ipertensione, indotta dalla gravidanza
- Disturbi puerperali
- Emorragia uterina
- Condizioni patologiche, segni e sintomi
- Eclampsia
- Emorragia postpartum
Altri numeri di identificazione dello studio
- Fidelity C
Piano per i dati dei singoli partecipanti (IPD)
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