Comparing Simulated Patients and Manikin Based Simulation in Obstetrics
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Vienna
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Individual inclusion criteria are: physician, midwife, registered nurse, or paramedic; current clinical duties in obstetric or peripartum emergency care
written informed consent
Disqualifiers
Pregnancy
Exclusion criteria are pregnancy and prior participation in a simulation study using the same obstetric scenarios.
Trial design
Design model
Parallel
Treatments tested in this trial
Trained, standardized patient
Other interventionTrained, standardized patient portraying obstetric woman with MamaNatalie simulator
MamaAnne Patient Simulator
Other interventionPatient portrayed by high fidelity obstetric manikin MamaAnne
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Trained Simulated PatientActive comparator 1 intervention
Group B: High-fidelity ManikinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
SRS-Score
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.
Time frame
Immediately after each scenario (scenario 1 and scenario 2, on the day of training)Secondary outcomes
1
Perceived realism on a Numeric Rating Scale (NRS)
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.
Time frame
Immediately after each scenario (scenario 1 and scenario 2, on the day of training)2
Themes on perceived realism and training experience (reflexive thematic analysis of focus groups)
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.
Time frame
Immediately after the debriefing of the second scenario, on the day of trainingSponsors and contacts
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Source ClinicalTrials.gov
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