Simulation Training(SBT)NCT06872879
The EFFECT of SIMULATION-BASED TRAINING on POSTPARTUM HAEMORRHAGE MANAGEMENT SKILLS
A study testing VEMS Simulation and Hybrit Simulation in people with Simulation Training and Nursing, run by Bandırma Onyedi Eylül University.
Trial summary
This study was planned to determine the effect of simulation-based training using two different reality levels-visually enhanced mental simulation (VEMS) and hybrid simulation-on postpartum haemorrhage (PPH) management skills in nursing students. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Simulation Training, Nursing, Postpartum Hemorrhage
- What is being tested?
- VEMS Simulation and Hybrit Simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 17 Mar 2025to 24 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Volunteering to participate in the research
- To have a grade point average of 2.00 and above
Who cannot join
- Not participating in all stages of the training programme
- Incomplete completion of data collection tools
- Wanting to leave the research.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The EFFECT of SIMULATION-BASED TRAINING with TWO DIFFERENT REALITY LEVELS on POSTPARTUM HAEMORRHAGE MANAGEMENT SKILLS in NURSING STUDENTS
This study was planned to determine the effect of simulation-based training using two different reality levels-visually enhanced mental simulation (VEMS) and hybrid simulation-on postpartum haemorrhage (PPH) management skills in nursing students.
Read the detailed description
This study will be conducted to determine the effect of simulation-based training using two different reality levels-visually enhanced mental simulation (VEMS) and hybrid simulation-on postpartum haemorrhage (PPH) management skills in nursing students. PPH is one of the leading causes of postpartum maternal mortality and its effective management requires the knowledge, skills and coordination of the healthcare team. However, it is difficult for nursing students to acquire these skills directly in the clinical environment due to rare observation and structural limitations in education. Simulation-based education stands out as an important method to develop such critical clinical skills.
In this randomised comparative study, 4th year students studying at Bandırma Onyedi Eylül University, Department of Nursing who have completed the course of Women's Health and Diseases Nursing in the spring semester of the 2024-2025 academic year will be included in the study. The sample size was calculated by G*Power analysis and a total of 64 students were randomly assigned to two groups. One of the intervention groups will receive PPH management training with VEMS method and the other will receive PPH management training with hybrid simulation. The training programme will be conducted within the scope of a structured curriculum including theoretical training, skills training and simulation applications.
'Participant Information Form', "Postpartum Haemorrhage Management Observation Form" and "Student Satisfaction and Confidence in Learning Scale" will be used to collect data. The skill levels of the students will be evaluated by two independent observers, and learning satisfaction and self-confidence levels will be measured through the scales.
The findings of the study are expected to provide important contributions in evaluating the effect of simulation-based training on PPH management skills. In particular, it is investigated whether the low-cost and highly applicable VEMS method is effective in terms of student satisfaction, confidence in learning and skill development as an alternative to traditional simulation approaches. The results obtained from the study may provide evidence-based recommendations to increase the efficiency of simulation applications in nursing education.
- Conditions
- Simulation Training, Nursing, Postpartum Hemorrhage
- Being tested
- VEMS Simulation, Hybrit Simulation
- Keywords
- Simulation Training, Nursing, Postpartum Hemorrhage
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VEMS SimulationOther
Students in the VEMS (Visually Enhanced Mental Simulation) group will receive a structured training programme to improve their PPH management skills. This process consists of three main stages: Theoretical training, skills training and simulation practice.
1.1 hour theoretical training will be given to the students to remind them the basic information about PPH management.
- PPH management will be mentally visualised step by step using VEMS materials. Students will be individually involved in the scenario and will apply the steps of PPH management in a mental simulation environment. After the scenario is completed, a 30-minute debriefing session will be organised.
- Manikin simulation will be used to evaluate students' PPH management skills. Students' PPH management skills will be evaluated using the "Postpartum Haemorrhage Management Observation Form". Attitudes towards the learning process will be measured by applying the Student Satisfaction and Confidence in Learning Scale.
Hybrit SimulationOther
Students in the hybrid simulation group will receive a simulation-based training in which the standard patient and part task trainer are used together. This process consists of three main stages: theoretical training, skills training and simulation practice.
1.1 hour theoretical training to remind basic information about PPH management. 2. Standard patient and part task trainers will be used in the skills training of the students. Students will make patient assessment, check vital signs and plan necessary interventions by contacting the standard patient.After the scenario is completed, a 30-minute debriefing session will be organised.
- Manikin simulation will be used to evaluate students' PPH management skills. Students' PPH management skills will be evaluated using the "Postpartum Haemorrhage Management Observation Form". Attitudes towards the learning process will be measured by applying the Student Satisfaction and Confidence in Learning Scale.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Students in the VEMS (Visually Enhanced Mental Simulation) group will receive a structured training programme to improve their PPH management skills. Receives: Other: VEMS Simulation |
| Group 2 | Active comparator | Students in the hybrid simulation group will receive a simulation-based training in which the standard patient and part task trainer are used together. Receives: Other: Hybrit Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PPH management skill levels
The form, which enables the assessment of students' skills in the PPH management process, consists of 25 steps.
Measured: 2 weeks after the completion of the simulation training
Satisfaction and self-confidence levels in learning
Student Satisfaction and Confidence in Learning Scale will be used.
Measured: 2 weeks after the completion of the simulation training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start17 Mar 2025 (estimated)
- Primary completion10 Apr 2025 (estimated)
- Study completion24 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simulation TrainingStudies 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
- The study was a parallel design randomised comparative study designed with equality experiment to determine the effect of simulation-based training using two different reality levels (visually enhanced mental simulation (VEMS) and hybrid simulation) on PPH management skills in nursing students.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yılda Arzu Aba, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872879
- Sponsor's protocol ID
- 2022-128
- Acronym
- (SBT)
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EFFECT of SIMULATION-BASED TRAINING with TWO DIFFERENT REALITY LEVELS on POSTPARTUM HAEMORRHAGE MANAGEMENT SKILLS in NURSING STUDENTS
- ClinicalTrials.gov ID
- NCT06872879
- Acronym / sponsor ID
- (SBT) / 2022-128
- Conditions
- Simulation Training, Nursing, Postpartum Hemorrhage
- Keywords
- Simulation Training, Nursing, Postpartum Hemorrhage
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 17 Mar 2025 (estimated)
- Primary completion
- 10 Apr 2025 (estimated)
- Study completion
- 24 Apr 2025 (estimated)
- First posted
- 12 Mar 2025 (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.
This study was planned to determine the effect of simulation-based training using two different reality levels-visually enhanced mental simulation (VEMS) and hybrid simulation-on postpartum haemorrhage (PPH) management skills in nursing students.
Detailed description
This study will be conducted to determine the effect of simulation-based training using two different reality levels-visually enhanced mental simulation (VEMS) and hybrid simulation-on postpartum haemorrhage (PPH) management skills in nursing students. PPH is one of the leading causes of postpartum maternal mortality and its effective management requires the knowledge, skills and coordination of the healthcare team. However, it is difficult for nursing students to acquire these skills directly in the clinical environment due to rare observation and structural limitations in education. Simulation-based education stands out as an important method to develop such critical clinical skills.
In this randomised comparative study, 4th year students studying at Bandırma Onyedi Eylül University, Department of Nursing who have completed the course of Women's Health and Diseases Nursing in the spring semester of the 2024-2025 academic year will be included in the study. The sample size was calculated by G*Power analysis and a total of 64 students were randomly assigned to two groups. One of the intervention groups will receive PPH management training with VEMS method and the other will receive PPH management training with hybrid simulation. The training programme will be conducted within the scope of a structured curriculum including theoretical training, skills training and simulation applications.
'Participant Information Form', "Postpartum Haemorrhage Management Observation Form" and "Student Satisfaction and Confidence in Learning Scale" will be used to collect data. The skill levels of the students will be evaluated by two independent observers, and learning satisfaction and self-confidence levels will be measured through the scales.
The findings of the study are expected to provide important contributions in evaluating the effect of simulation-based training on PPH management skills. In particular, it is investigated whether the low-cost and highly applicable VEMS method is effective in terms of student satisfaction, confidence in learning and skill development as an alternative to traditional simulation approaches. The results obtained from the study may provide evidence-based recommendations to increase the efficiency of simulation applications in nursing education.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study was a parallel design randomised comparative study designed with equality experiment to determine the effect of simulation-based training using two different reality levels (visually enhanced mental simulation (VEMS) and hybrid simulation) on PPH management skills in nursing students.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: VEMS SimulationStudents in the VEMS (Visually Enhanced Mental Simulation) group will receive a structured training programme to improve their PPH management skills. |
| Group 2 | Active comparator | Other: Hybrit SimulationStudents in the hybrid simulation group will receive a simulation-based training in which the standard patient and part task trainer are used together. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Volunteering to participate in the research
- To have a grade point average of 2.00 and above
Key exclusion criteria (3 listed)
- Not participating in all stages of the training programme
- Incomplete completion of data collection tools
- Wanting to leave the research.
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 |
|---|---|---|
| VEMS SimulationStudents in the VEMS (Visually Enhanced Mental Simulation) group will receive a structured training programme to improve their PPH management skills. This process consists of three main stages: Theoretical training, skills training and simulation practice. 1.1 hour theoretical training will be given to the students to remind them the basic information about PPH management. 2. PPH management will be mentally visualised step by step using VEMS materials. Students will be individually involved in the scenario and will apply the steps of PPH management in a mental simulation environment. After the scenario is completed, a 30-minute debriefing session will be organised. 3. Manikin simulation will be used to evaluate students' PPH management skills. Students' PPH management skills will be evaluated using the "Postpartum Haemorrhage Management Observation Form". Attitudes towards the learning process will be measured by applying the Student Satisfaction and Confidence in Learning Scale. | Other | Group 1 |
| Hybrit SimulationStudents in the hybrid simulation group will receive a simulation-based training in which the standard patient and part task trainer are used together. This process consists of three main stages: theoretical training, skills training and simulation practice. 1.1 hour theoretical training to remind basic information about PPH management. 2. Standard patient and part task trainers will be used in the skills training of the students. Students will make patient assessment, check vital signs and plan necessary interventions by contacting the standard patient.After the scenario is completed, a 30-minute debriefing session will be organised. 3. Manikin simulation will be used to evaluate students' PPH management skills. Students' PPH management skills will be evaluated using the "Postpartum Haemorrhage Management Observation Form". Attitudes towards the learning process will be measured by applying the Student Satisfaction and Confidence in Learning Scale. | Other | Group 2 |
Primary outcome
PPH management skill levels
Time frame: 2 weeks after the completion of the simulation training
The form, which enables the assessment of students' skills in the PPH management process, consists of 25 steps.
Satisfaction and self-confidence levels in learning
Time frame: 2 weeks after the completion of the simulation training
Student Satisfaction and Confidence in Learning Scale will be used.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing VEMS Simulation and Hybrit Simulation in people with Simulation Training and Nursing, run by Bandırma Onyedi Eylül University.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yılda Arzu ABA, RN, Professor (+90 505 567 04 83, yaba@bandirma.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PPH management skill levels (time frame: 2 weeks after the completion of the simulation training). 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 12 Mar 2025.