Postpartum HemorrhageNCT07912021
The Effect of Using Virtual Simulation on Students' Knowledge and Skill Levels Regarding Postpartum Hemorrhage Management
A study testing Virtual Simulation and Case Study in people with Postpartum Hemorrhage and Nursing Education, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to find out whether virtual simulation helps nursing students learn how to manage postpartum hemorrhage (heavy bleeding after childbirth). Third-year nursing students taking the Obstetrics and Gynecology Nursing course were randomly assigned to one of three groups: virtual simulation, case… 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, Nursing Education, Virtual Simulation
- What is being tested?
- Virtual Simulation and Case Study
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Oct 2025to 12 Dec 2025
- 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 a nursing student at Eskisehir Osmangazi University Faculty of Health Sciences, Department of Nursing
- Being enrolled in the Obstetrics and Gynecology Nursing course
- Taking the Obstetrics and Gynecology Nursing course for the first time
- Having a smartphone with an Android or iOS operating system, or a computer
- Having no communication problems
- Volunteering to participate in the study and providing written informed consent
Who cannot join
- Being a graduate of the nursing assistant or midwifery assistant programs of vocational health high schools
- Withdrawal Criteria (after randomization):
- Not completing the assigned intervention (virtual simulation scenarios or case studies)
- Not completing, or incompletely completing, the knowledge test at any measurement point
- Not attending the skill assessment
- Inability to evaluate the video recording of the skill assessment due to technical reasons (excluded from the skill analysis only)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi University Faculty of Health Sciences
Eskişehir, Eskişehir, 26040
About this study
Official title: The Effect of Using Virtual Simulation on Students' Knowledge and Skill Levels Regarding Postpartum Hemorrhage Management: Randomized Controlled Study
The purpose of this study is to find out whether virtual simulation helps nursing students learn how to manage postpartum hemorrhage (heavy bleeding after childbirth). Third-year nursing students taking the Obstetrics and Gynecology Nursing course were randomly assigned to one of three groups: virtual simulation, case study, or control. Students' knowledge was measured with a postpartum hemorrhage knowledge test, and their skills were assessed with a skill evaluation checklist during a hybrid simulation scenario. The results will show whether virtual simulation improves students' knowledge and skills compared with case study and standard education.
Read the detailed description
Background: Postpartum hemorrhage (PPH) remains one of the leading causes of maternal mortality worldwide. Nurses play a critical role in the early recognition and timely management of PPH; however, nursing students have limited opportunities to gain clinical experience in this obstetric emergency. Virtual simulation provides a safe, standardized, and repeatable learning environment that may support the development of knowledge and clinical skills in such high-risk, low-frequency situations.
Objective: This randomized controlled trial aims to evaluate the effect of virtual simulation on nursing students' knowledge and skill levels regarding postpartum hemorrhage management, compared with case-based learning and standard education.
Methods: The study was conducted with third-year nursing students enrolled in the Obstetrics and Gynecology Nursing course at Eskisehir Osmangazi University. Prior to the main study, a pilot study was conducted with 15 fourth-year nursing students who had previously completed the course. These students were outside the study population and were not included in the sample or the analysis.
After written informed consent was obtained and the Student Descriptive Characteristics Form was completed, participants were allocated to three groups using stratified randomization: virtual simulation group, case study group, and control group. All participants received standard theoretical education on postpartum hemorrhage, after which the Postpartum Hemorrhage Knowledge Test was administered as a pretest.
Following the theoretical education, students in the virtual simulation group were given a brief orientation to the platform and completed five virtual simulation scenarios on postpartum hemorrhage management over a one-week period. Students in the case study group worked on written case studies based on the same scenarios and developed nursing care plans in small groups of 8-10 students via the Zoom platform. The control group received no additional intervention beyond standard education.
The knowledge test was administered to all groups one week after the intervention (posttest) and four weeks after the intervention (follow-up). Clinical skills were subsequently assessed using the Skill Evaluation Checklist during a hybrid simulation scenario with standardized patients, conducted in mixed groups. Each simulation session was followed by a structured debriefing, after which the knowledge test was administered for the fourth time. Upon completion of the study, students in the control group were given access to the virtual simulation platform for ethical reasons.
Funding: This study was funded by Eskisehir Osmangazi University Scientific Research Projects Coordination Unit (Project No: TDK-2025-3302).
- Conditions
- Postpartum Hemorrhage, Nursing Education, Virtual Simulation
- Being tested
- Virtual Simulation, Case Study
- Keywords
- Virtual Simulation, Simulation Training, Nursing Education, Postpartum Hemorrhage, Hybrid Simulation, Case-Based Learning
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual SimulationBehavioural
Following a brief orientation (approximately 15 minutes), students completed virtual simulation scenarios on postpartum hemorrhage management over one week.
Case StudyBehavioural
Students worked on written case studies based on the same postpartum hemorrhage scenarios and developed nursing care plans in small groups of 8-10 via the Zoom platform.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Simulation Group | Experimental | Students received standard theoretical education on postpartum hemorrhage, followed by a brief platform orientation and completion of five virtual simulation scenarios on postpartum hemorrhage management over a one-week period. Receives: Behavioral: Virtual Simulation |
| Case Study Group | Active comparator | Students received standard theoretical education on postpartum hemorrhage, followed by case studies based on the same scenarios used in the virtual simulation group. Students developed nursing care plans in small groups of 8-10 via the Zoom platform. Receives: Behavioral: Case Study |
| Control Group | No intervention | Students received only standard theoretical education on postpartum hemorrhage included in the course curriculum, with no additional intervention. After the study was completed, students were given access to the virtual simulation platform for ethical reasons. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum Hemorrhage Knowledge Level
Students' knowledge of postpartum hemorrhage management was assessed using the Postpartum Hemorrhage Knowledge Test developed by Citak and Duran Aksoy (2023). The test consists of 20 questions; each correct answer is scored as 1 point, and each incorrect or blank answer as 0 points. Total scores range from 0 to 20, with higher scores indicating a higher level of knowledge.
Measured: Baseline (after theoretical education), 1 week post-intervention, 4 weeks post-intervention, and immediately after the skill assessment.
Postpartum Hemorrhage Management Skill Level
Students' skills in postpartum hemorrhage management were assessed during a hybrid simulation scenario with standardized patients using the Postpartum Hemorrhage Management Skill Evaluation Form developed by Mert-Karadas and Terzioglu (2019).Each item is rated on a 5-point scale from 0 (performed none of the activities) to 4 (performed all of the activities), yielding a total score ranging from 0 to 160. Higher scores indicate a higher level of skill. A situation-specific scoring approach was used, and outcome assessors were blinded to group allocation.
Measured: 4-5 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start22 Oct 2025
- Primary completion12 Dec 2025
- Study completion12 Dec 2025
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
- Model description
- Participants were randomly allocated to one of three parallel groups: virtual simulation group, case study group, and control group. All groups received standard theoretical education on postpartum hemorrhage. In addition, the virtual simulation group completed virtual simulation scenarios, the case study group completed case studies based on the same scenarios, and the control group received no additional intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 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
- NCT07912021
- Sponsor's protocol ID
- TDK-2025-3302
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 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, as the informed consent obtained from participants did not include permission for data sharing with third parties and in order to protect participant confidentiality. The study findings will be disseminated in aggregate form through the doctoral thesis and peer-reviewed publications.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Virtual Simulation on Students' Knowledge and Skill Levels Regarding Postpartum Hemorrhage Management: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07912021
- Acronym / sponsor ID
- TDK-2025-3302
- Conditions
- Postpartum Hemorrhage, Nursing Education, Virtual Simulation
- Keywords
- Virtual Simulation, Simulation Training, Nursing Education, Postpartum Hemorrhage, Hybrid Simulation, Case-Based Learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Collaborators
- Eskisehir Osmangazi University
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 3 Nov 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.
The purpose of this study is to find out whether virtual simulation helps nursing students learn how to manage postpartum hemorrhage (heavy bleeding after childbirth). Third-year nursing students taking the Obstetrics and Gynecology Nursing course were randomly assigned to one of three groups: virtual simulation, case study, or control. Students' knowledge was measured with a postpartum hemorrhage knowledge test, and their skills were assessed with a skill evaluation checklist during a hybrid simulation scenario. The results will show whether virtual simulation improves students' knowledge and skills compared with case study and standard education.
Detailed description
Background: Postpartum hemorrhage (PPH) remains one of the leading causes of maternal mortality worldwide. Nurses play a critical role in the early recognition and timely management of PPH; however, nursing students have limited opportunities to gain clinical experience in this obstetric emergency. Virtual simulation provides a safe, standardized, and repeatable learning environment that may support the development of knowledge and clinical skills in such high-risk, low-frequency situations.
Objective: This randomized controlled trial aims to evaluate the effect of virtual simulation on nursing students' knowledge and skill levels regarding postpartum hemorrhage management, compared with case-based learning and standard education.
Methods: The study was conducted with third-year nursing students enrolled in the Obstetrics and Gynecology Nursing course at Eskisehir Osmangazi University. Prior to the main study, a pilot study was conducted with 15 fourth-year nursing students who had previously completed the course. These students were outside the study population and were not included in the sample or the analysis.
After written informed consent was obtained and the Student Descriptive Characteristics Form was completed, participants were allocated to three groups using stratified randomization: virtual simulation group, case study group, and control group. All participants received standard theoretical education on postpartum hemorrhage, after which the Postpartum Hemorrhage Knowledge Test was administered as a pretest.
Following the theoretical education, students in the virtual simulation group were given a brief orientation to the platform and completed five virtual simulation scenarios on postpartum hemorrhage management over a one-week period. Students in the case study group worked on written case studies based on the same scenarios and developed nursing care plans in small groups of 8-10 students via the Zoom platform. The control group received no additional intervention beyond standard education.
The knowledge test was administered to all groups one week after the intervention (posttest) and four weeks after the intervention (follow-up). Clinical skills were subsequently assessed using the Skill Evaluation Checklist during a hybrid simulation scenario with standardized patients, conducted in mixed groups. Each simulation session was followed by a structured debriefing, after which the knowledge test was administered for the fourth time. Upon completion of the study, students in the control group were given access to the virtual simulation platform for ethical reasons.
Funding: This study was funded by Eskisehir Osmangazi University Scientific Research Projects Coordination Unit (Project No: TDK-2025-3302).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants were randomly allocated to one of three parallel groups: virtual simulation group, case study group, and control group. All groups received standard theoretical education on postpartum hemorrhage. In addition, the virtual simulation group completed virtual simulation scenarios, the case study group completed case studies based on the same scenarios, and the control group received no additional intervention.
| Arm | Type | Receives |
|---|---|---|
| Virtual Simulation Group | Experimental | Behavioral: Virtual SimulationStudents received standard theoretical education on postpartum hemorrhage, followed by a brief platform orientation and completion of five virtual simulation scenarios on postpartum hemorrhage management over a one-week period. |
| Case Study Group | Active comparator | Behavioral: Case StudyStudents received standard theoretical education on postpartum hemorrhage, followed by case studies based on the same scenarios used in the virtual simulation group. Students developed nursing care plans in small groups of 8-10 via the Zoom platform. |
| Control Group | No intervention | –Students received only standard theoretical education on postpartum hemorrhage included in the course curriculum, with no additional intervention. After the study was completed, students were given access to the virtual simulation platform for ethical reasons. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being a nursing student at Eskisehir Osmangazi University Faculty of Health Sciences, Department of Nursing
- Being enrolled in the Obstetrics and Gynecology Nursing course
- Taking the Obstetrics and Gynecology Nursing course for the first time
- Having a smartphone with an Android or iOS operating system, or a computer
- Having no communication problems
Key exclusion criteria (6 listed)
- Being a graduate of the nursing assistant or midwifery assistant programs of vocational health high schools
- Not completing the assigned intervention (virtual simulation scenarios or case studies)
- Not completing, or incompletely completing, the knowledge test at any measurement point
- Not attending the skill assessment
- Inability to evaluate the video recording of the skill assessment due to technical reasons (excluded from the skill analysis only)
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 |
|---|---|---|
| Virtual SimulationFollowing a brief orientation (approximately 15 minutes), students completed virtual simulation scenarios on postpartum hemorrhage management over one week. | Behavioural | Virtual Simulation Group |
| Case StudyStudents worked on written case studies based on the same postpartum hemorrhage scenarios and developed nursing care plans in small groups of 8-10 via the Zoom platform. | Behavioural | Case Study Group |
Primary outcome
Postpartum Hemorrhage Knowledge Level
Time frame: Baseline (after theoretical education), 1 week post-intervention, 4 weeks post-intervention, and immediately after the skill assessment.
Students' knowledge of postpartum hemorrhage management was assessed using the Postpartum Hemorrhage Knowledge Test developed by Citak and Duran Aksoy (2023). The test consists of 20 questions; each correct answer is scored as 1 point, and each incorrect or blank answer as 0 points. Total scores range from 0 to 20, with higher scores indicating a higher level of knowledge.
Postpartum Hemorrhage Management Skill Level
Time frame: 4-5 weeks post-intervention
Students' skills in postpartum hemorrhage management were assessed during a hybrid simulation scenario with standardized patients using the Postpartum Hemorrhage Management Skill Evaluation Form developed by Mert-Karadas and Terzioglu (2019).Each item is rated on a 5-point scale from 0 (performed none of the activities) to 4 (performed all of the activities), yielding a total score ranging from 0 to 160. Higher scores indicate a higher level of skill. A situation-specific scoring approach was used, and outcome assessors were blinded to group allocation.
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 3 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared, as the informed consent obtained from participants did not include permission for data sharing with third parties and in order to protect participant confidentiality. The study findings will be disseminated in aggregate form through the doctoral thesis and peer-reviewed publications.
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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 Virtual Simulation and Case Study in people with Postpartum Hemorrhage and Nursing Education, 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 6 inclusion and 6 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 3 Nov 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?
Postpartum Hemorrhage Knowledge Level (time frame: Baseline (after theoretical education), 1 week post-intervention, 4 weeks post-intervention, and immediately after the skill assessment.). 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 3 Nov 2026; AzTrials last refreshed its copy on 4 Nov 2026.