Comparing Simulated Patients and Manikin Based Simulation in Obstetrics

NCT07857551 — Not applicable, Not yet recruiting, 72 participants, Medical University of Vienna

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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

Registry	NCT07857551
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, other
Enrollment	72 (Estimated)
Sponsor	Medical University of Vienna (Other)
Conditions	PPH - Postpartum Hemorrhage, Eclampsia
Interventions	Trained, standardized patient, MamaAnne Patient Simulator (Other)
Dates	start 2026-10-15 (estimated), primary completion 2029-01-01 (estimated), completion 2029-01-01 (estimated), first posted 2026-10-05, last updated 2026-10-05
Locations	1 site in Austria

-Summary

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.

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Trained Simulated Patient	Active comparator	Other: Trained, standardized 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).
High-fidelity Manikin	Experimental	Other: MamaAnne Patient Simulator	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).

Trained, standardized patient (Other), also known as Arm 1: Standardized Patient: Trained, standardized patient portraying obstetric woman with MamaNatalie simulator
MamaAnne Patient Simulator (Other): Patient portrayed by high fidelity obstetric manikin MamaAnne

+Outcome measures

Primary outcomes

SRS-Score [Immediately after each scenario (scenario 1 and scenario 2, on the day of training)]: 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.

Secondary outcomes

Perceived realism on a Numeric Rating Scale (NRS) [Immediately after each scenario (scenario 1 and scenario 2, on the day of training)]: 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.
Themes on perceived realism and training experience (reflexive thematic analysis of focus groups) [Immediately after the debriefing of the second scenario, on the day of training]: 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.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Medical University of Vienna	Vienna, State of Vienna	Austria