Postpartum HemorrhageNCT07854106
Hybrid Simulation in Postpartum Hemorrhage Training for Nursing Students
A study testing Hybrid Simulation-Based PPH Training and Standard Education in people with Postpartum Hemorrhage and Simulation Training, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage, Simulation Training, Nursing Education
- What is being tested?
- Hybrid Simulation-Based PPH Training and Standard Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Feb 2026to 29 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi University Faculty of Health Sciences
Eskişehir, Eyalet/İl Seçin
About this study
Official title: 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.
Read more
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.
- Conditions
- Postpartum Hemorrhage, Simulation Training, Nursing Education, Clinical Readiness, Learning Satisfaction and Self-confidence
- Being tested
- Hybrid Simulation-Based PPH Training, Standard Education
- Keywords
- Postpartum Hemorrhage, Clinical Readiness, Simulation Training, Nursing education, learning satisfaction and self-confidence
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Simulation-Based PPH TrainingBehavioural
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.
Standard EducationBehavioural
Students receive traditional curriculum-based theoretical education and standard lecture-based instruction on postpartum hemorrhage management.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Nursing students receiving hybrid simulation-based postpartum hemorrhage (PPH) management training. Receives: Behavioral: Hybrid Simulation-Based PPH Training |
| Control Group | Active comparator | Nursing students receiving standard postpartum hemorrhage management education. Receives: Behavioral: Standard Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readiness for Nursing Practice Scale
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.
Measured: Baseline and immediately post-intervention
Student Satisfaction and Self-Confidence in Learning Scale
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.
Measured: Baseline and immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start23 Feb 2026
- Primary completion24 Mar 2026
- Study completion29 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Collaborators
- Eskisehir Osmangazi University
- Responsible party
- Principal investigator, Meryem Unulu, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854106
- Sponsor's protocol ID
- UludagU-SHMYO-MU-02
- Other IDs
- 2025-SBB-1124
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07854106
- Acronym / sponsor ID
- UludagU-SHMYO-MU-02
- Conditions
- Postpartum Hemorrhage, Simulation Training, Nursing Education, Clinical Readiness, Learning Satisfaction and Self-confidence
- Keywords
- Postpartum Hemorrhage, Clinical Readiness, Simulation Training, Nursing education, learning satisfaction and self-confidence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Collaborators
- Eskisehir Osmangazi University
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 24 Mar 2026 (actual)
- Study completion
- 29 Jul 2026 (actual)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Hybrid Simulation-Based PPH TrainingNursing students receiving hybrid simulation-based postpartum hemorrhage (PPH) management training. |
| Control Group | Active comparator | Behavioral: Standard EducationNursing students receiving standard postpartum hemorrhage management education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid Simulation-Based PPH TrainingStudents receive interactive hybrid simulation-based training combining standardized patients and task trainers focused on postpartum hemorrhage management skills, clinical decision-making, and team communication. | Behavioural | Intervention Group |
| Standard EducationStudents receive traditional curriculum-based theoretical education and standard lecture-based instruction on postpartum hemorrhage management. | Behavioural | Control Group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Simulation-Based PPH Training and Standard Education in people with Postpartum Hemorrhage and Simulation Training, run by Uludag University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readiness for Nursing Practice Scale (time frame: Baseline and immediately post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.