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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Mathias Maleczek, PD Dr.
- 电话号码:+4314040041020
- 邮箱:mathias.maleczek@meduniwien.ac.at
研究联系人备份
- 姓名:Florian Berger, Dr.
- 电话号码:+4314040041020
- 邮箱:florian.berger@meduniwien.ac.at
学习地点
-
-
State of Vienna
-
Vienna、State of Vienna、奥地利、1090
- Medical University of Vienna
-
接触:
- Mathias Maleczek, PD Dr.
- 电话号码:+4314040041020
- 邮箱:mathias.maleczek@meduniwien.ac.at
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器: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
其他名称:
|
|
实验性的: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 |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
SRS-Score
大体时间: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. |
Immediately after each scenario (scenario 1 and scenario 2, on the day of training)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Perceived realism on a Numeric Rating Scale (NRS)
大体时间: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. |
Immediately after each scenario (scenario 1 and scenario 2, on the day of training)
|
|
Themes on perceived realism and training experience (reflexive thematic analysis of focus groups)
大体时间: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. |
Immediately after the debriefing of the second scenario, on the day of training
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.