- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06872879
The EFFECT of SIMULATION-BASED TRAINING on POSTPARTUM HAEMORRHAGE MANAGEMENT SKILLS ((SBT))
The EFFECT of SIMULATION-BASED TRAINING with TWO DIFFERENT REALITY LEVELS on POSTPARTUM HAEMORRHAGE MANAGEMENT SKILLS in NURSING STUDENTS
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yılda Arzu ABA, RN, Professor
- Phone Number: +90 505 567 04 83
- Email: yaba@bandirma.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Volunteering to participate in the research
- To have a grade point average of 2.00 and above
Exclusion Criteria:
- Not participating in all stages of the training programme
- Incomplete completion of data collection tools
- Wanting to leave the research.
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 |
|---|---|
|
Active Comparator: Group 1
Students in the VEMS (Visually Enhanced Mental Simulation) group will receive a structured training programme to improve their PPH management skills.
|
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. 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. |
|
Active Comparator: Group 2
Students in the hybrid simulation group will receive a simulation-based training in which the standard patient and part task trainer are used together.
|
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. 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2 weeks after the completion of the simulation training
|
|
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.
|
2 weeks after the completion of the simulation training
|
Collaborators and Investigators
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-128
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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