- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07854106
Hybrid Simulation in Postpartum Hemorrhage Training for Nursing Students
The Effect of Hybrid Simulation-Based Postpartum Hemorrhage Management Training on Nursing Students' Satisfaction, Self-Confidence, and Clinical Readiness in Women's Health Nursing Education: A Randomized Controlled Trial
Abstract Postpartum hemorrhage (PPH) is a leading cause of maternal mortality and morbidity worldwide, requiring nursing students to acquire both theoretical knowledge and clinical competence for safe and effective management. Hybrid simulation, integrating standardized patients with high-fidelity simulators, is an innovative educational approach that simultaneously enhances communication and psychomotor skills.
This prospective randomized controlled study aims to evaluate the effects of a hybrid simulation-based postpartum hemorrhage management training on nursing students' learning satisfaction, self-confidence, and clinical readiness.
The study was conducted with third-year nursing students at Eskisehir Osmangazi University Faculty of Health Sciences, Department of Nursing. Participants were randomly assigned to either an intervention group receiving hybrid simulation-based training using standardized patients and a birthing simulator, or a control group receiving routine education.
Data were collected before and after the intervention using a Personal Information Form, the Student Satisfaction and Self-Confidence in Learning Scale, and the Nursing Clinical Readiness Scale to evaluate outcomes between the groups.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Eyalet/İl Seçin
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Eskişehir, Eyalet/İl Seçin, Turkey (Türkiye)
- Eskisehir Osmangazi University Faculty of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being an undergraduate nursing student at Eskisehir Osmangazi University Faculty of Health Sciences
- Being a third-year student enrolled in the Women's Health and Diseases Nursing course for the first time
- Volunteering to participate and providing written informed consent
- Not having previously received structured simulation training on postpartum hemorrhage management
- Having no physical, cognitive, or psychiatric health conditions that impair communication
Exclusion Criteria:
- Incomplete completion of data collection instruments
- Non-attendance at pre-test or post-test assessments
- Failure to complete the assigned educational intervention
- Withdrawal of consent or voluntary withdrawal at any stage of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Nursing students receiving hybrid simulation-based postpartum hemorrhage (PPH) management training. |
Students receive interactive hybrid simulation-based training combining standardized patients and task trainers focused on postpartum hemorrhage management skills, clinical decision-making, and team communication. |
|
Active Comparator: Control Group
Nursing students receiving standard postpartum hemorrhage management education. |
Students receive traditional curriculum-based theoretical education and standard lecture-based instruction on postpartum hemorrhage management. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Readiness for Nursing Practice Scale
Time Frame: Baseline and immediately post-intervention
|
Assessed using the Turkish version of the Nursing Clinical Readiness Scale (originally developed by Kim and Shin, 2022; Turkish validation by Kavuran et al., 2023) to evaluate nursing students' clinical readiness in managing postpartum hemorrhage. The scale consists of 35 items rated on a 10-point Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree). Total scores range from 35 to 350 (or mean item scores from 1 to 10), where higher scores indicate a higher level of clinical readiness. |
Baseline and immediately post-intervention
|
|
Student Satisfaction and Self-Confidence in Learning Scale
Time Frame: Baseline and immediately post-intervention
|
Assessed using the Turkish version of the Student Satisfaction and Self-Confidence in Learning Scale (originally developed by Jeffries and Rizzolo, 2006; Turkish validation by Unver et al., 2017). The scale consists of 12 items across two subscales: Satisfaction with Current Learning (5 items) and Self-Confidence in Learning (7 items), rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Scores are calculated by dividing the sum of scores by the number of items, with mean scores ranging from 1 to 5 (total score range: 12 to 60), where higher scores indicate higher levels of student satisfaction and self-confidence in learning. |
Baseline and immediately post-intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- UludagU-SHMYO-MU-02
- 2025-SBB-1124 (Other Identifier: Bartın University Social and Human Sciences Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Individual participant data will not be shared publicly to protect participant confidentiality. De-identified data may be made available from the corresponding author upon reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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