- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07519252
Effect of Simulation-Based Postpartum Hemorrhage Training on Team Performance in Senior Anesthesiology Teams (PPH-SIM)
A Prospective Interventional Study Evaluating the Effect of Simulation-Based Postpartum Hemorrhage Training on Team Performance and Crisis Resource Management Skills Among Senior Anesthesiology Residents
Study Overview
Status
Intervention / Treatment
Detailed Description
Postpartum hemorrhage (PPH) remains a leading cause of maternal morbidity and mortality worldwide, requiring rapid recognition and effective team-based management. Simulation-based training has emerged as a valuable educational tool to enhance both technical and non-technical skills in high-risk clinical scenarios.
This prospective interventional study is designed to assess the impact of simulation-based postpartum hemorrhage training on team performance and crisis resource management (CRM) skills among senior anesthesiology residents. Participants will take part in a structured high-fidelity simulation program replicating obstetric hemorrhage scenarios.
Performance will be evaluated using validated scoring systems for crisis resource management and team performance, including assessments of leadership, communication, situational awareness, and decision-making. Pre- and post-training evaluations will be conducted to measure the effectiveness of the intervention.
The primary objective is to determine whether simulation-based training improves overall team performance. Secondary outcomes include improvements in communication skills, response time, adherence to clinical protocols, and self-reported confidence levels.
This study aims to contribute to the growing body of evidence supporting simulation-based education in anesthesiology and obstetric emergency management.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mehmet Kırıköz, MD
- Phone Number: +905364524996
- Email: mehmetkirikoz@hacettepe.edu.tr
Study Contact Backup
- Name: Banu Kılıçaslan, MD
Study Locations
-
-
Ankara
-
Ankara, Ankara, Turkey (Türkiye), 06100
- Hacettepe University Faculty of Medicine
-
Principal Investigator:
- Banu Kılıçaslan, MD
-
Contact:
- Mehmet Kırıköz, MD
- Phone Number: +905364524996
- Email: mehmetkirikoz@hacettepe.edu.tr
-
Contact:
- Banu Kılıçaslan, MD
- Phone Number: +903123051250 +905322969290
- Email: banuk9oct@gmail.com
-
Sub-Investigator:
- Mehmet Kırıköz, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Senior anesthesiology residents
- Currently working in the department of anesthesiology and reanimation
- Voluntary participation in the study
Exclusion Criteria:
- Refusal to participate
- Incomplete participation in the simulation session
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Simulation-Based Training Group
Participants will undergo a structured high-fidelity simulation-based training program focused on postpartum hemorrhage management.
Performance will be assessed before and after the intervention.
|
High-fidelity simulation-based training designed to improve management of postpartum hemorrhage, including crisis resource management skills, team communication, and clinical decision-making.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Crisis Resource Management (CRM) Score
Time Frame: Baseline and immediately after simulation training
|
Team performance will be assessed using a validated Crisis Resource Management (CRM) scoring system based on a 5-point Likert scale (1-5).
Each item is scored from 1 (poor performance) to 5 (excellent performance), with higher scores indicating better team performance.
Scores will be recorded before and immediately after the simulation-based training, and the change in total CRM score will be analyzed.
|
Baseline and immediately after simulation training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Team Performance Score
Time Frame: Baseline and immediately after simulation training
|
Team performance will be evaluated using a structured assessment tool focusing on communication, leadership, and coordination during simulation scenarios.
The assessment is based on a 5-point Likert scale (1-5), where higher scores indicate better performance.
Scores will be recorded before and immediately after the simulation-based training.
|
Baseline and immediately after simulation training
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mehmet Kırıköz, MD, Hacettepe University
- Study Director: Banu Kılıçaslan, MD, Hacettepe University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUTF-ANES-PPH-2026
- THD-2025-22292 (Other Identifier: Hacettepe University Scientific Research Projects Unit)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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