SimulationNCT06870227
Scenario-Based Simulation
A study testing Using High Reality Simulator in people with Simulation, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of Scenario-Based Simulation on Clinical Learning, Confidence and Satisfaction of Midwifery Students in Management of Eclampsia Crisis in Labor Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Simulation
- What is being tested?
- Using High Reality Simulator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 1 Mar 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteer to participate in the study
- Take the Obstetric Emergencies course
Who cannot join
- Not volunteering to participate in the study
- Not taking the obstetric emergencies course
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Scenario-Based Simulation on Clinical Learning, Confidence and Satisfaction of Midwifery Students in Management of Eclampsia Crisis in Labor
The aim of this study is to determine the effect of Scenario-Based Simulation on Clinical Learning, Confidence and Satisfaction of Midwifery Students in Management of Eclampsia Crisis in Labor
Read the detailed description
Hypotheses 01; there was no difference between the clinical learning score of the experimental group and the pain score of the control group.
H02; there was no difference between the confidence score of the experimental group and the confidence score of the control group.
H03; there was no difference between the satisfaction score of the of the experimental group and the satisfaction score of the control group.
The study will be carried out in two different groups. The practice will start with meeting the students. After the students are evaluated in terms of eligibility criteria for the research, the students who are eligible will be informed about the research and written informed consent will be obtained from the students who accept. The random distribution of students to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.
Eclampsia Crisis in Labor training will be given by the responsible investigator, and then one of the groups separated by randomization will perform Eclampsia Crisis in Labor first care on the second group model using High Reality Simulator. These trainings will first be in the form of the instructor responsible for the groups demonstrating the application, and then the students will apply it one by one
- Conditions
- Simulation
- Being tested
- Using High Reality Simulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using High Reality SimulatorOther
Using High Reality Simulator will perform emergency eclampsia in labour
| Study group | Role | What they receive |
|---|---|---|
| High Reality Simulator | Experimental | Eclampsia Crisis in Labor management training will be given by the responsible investigator, and then one of the groups will be allocated by randomization. Using High Reality Simulator will perform emergency Eclampsia Crisis in Labor. These trainings will first be in the form of the instructor responsible for the groups demonstrating the application, and then the students will apply it one by one. Receives: Other: Using High Reality Simulator |
| control group | No intervention | Using model will perform emergency y Eclampsia Crisis in Labor. These trainings will first be in the form of the instructor responsible for the groups demonstrating the application, and then the students will apply it one by one. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Confidence/Competence in Patient Intervention Scale
The validity and reliability study of the scale was conducted by Terzioğlu et al (2012). The scale was developed for health professional students who had experience in teaching based on scenario-based simulation. 3 factors were obtained in the explanatory factor analysis. The three factors were classified as clinical practice (11 items), psychological support (4 items) and health care system knowledge (3 items). The validity results of the scale were evaluated between 0.80 and 0.94. The Cronbach Alpha internal consistency coefficient of the scale was 0.947. The scale contains a total of 18 items and is evaluated according to the 5-point Likert system.
Measured: immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Dec 2025
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SimulationStudies 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
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sümeyye BAL, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870227
- Sponsor's protocol ID
- 2024/572
- Status last verified
- Jul 2026
- First submitted
- 5 Mar 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Scenario-Based Simulation on Clinical Learning, Confidence and Satisfaction of Midwifery Students in Management of Eclampsia Crisis in Labor
- ClinicalTrials.gov ID
- NCT06870227
- Acronym / sponsor ID
- 2024/572
- Conditions
- Simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 11 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.
The aim of this study is to determine the effect of Scenario-Based Simulation on Clinical Learning, Confidence and Satisfaction of Midwifery Students in Management of Eclampsia Crisis in Labor
Detailed description
Hypotheses 01; there was no difference between the clinical learning score of the experimental group and the pain score of the control group.
H02; there was no difference between the confidence score of the experimental group and the confidence score of the control group.
H03; there was no difference between the satisfaction score of the of the experimental group and the satisfaction score of the control group.
The study will be carried out in two different groups. The practice will start with meeting the students. After the students are evaluated in terms of eligibility criteria for the research, the students who are eligible will be informed about the research and written informed consent will be obtained from the students who accept. The random distribution of students to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.
Eclampsia Crisis in Labor training will be given by the responsible investigator, and then one of the groups separated by randomization will perform Eclampsia Crisis in Labor first care on the second group model using High Reality Simulator. These trainings will first be in the form of the instructor responsible for the groups demonstrating the application, and then the students will apply it one by one
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Reality Simulator | Experimental | Other: Using High Reality SimulatorEclampsia Crisis in Labor management training will be given by the responsible investigator, and then one of the groups will be allocated by randomization. Using High Reality Simulator will perform emergency Eclampsia Crisis in Labor. These trainings will first be in the form of the instructor responsible for the groups demonstrating the application, and then the students will apply it one by one. |
| control group | No intervention | –Using model will perform emergency y Eclampsia Crisis in Labor. These trainings will first be in the form of the instructor responsible for the groups demonstrating the application, and then the students will apply it one by one. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Volunteer to participate in the study
- Take the Obstetric Emergencies course
Key exclusion criteria (2 listed)
- Not volunteering to participate in the study
- Not taking the obstetric emergencies course
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 |
|---|---|---|
| Using High Reality SimulatorUsing High Reality Simulator will perform emergency eclampsia in labour | Other | High Reality Simulator |
Primary outcome
Self-Confidence/Competence in Patient Intervention Scale
Time frame: immediately after intervention
The validity and reliability study of the scale was conducted by Terzioğlu et al (2012). The scale was developed for health professional students who had experience in teaching based on scenario-based simulation. 3 factors were obtained in the explanatory factor analysis. The three factors were classified as clinical practice (11 items), psychological support (4 items) and health care system knowledge (3 items). The validity results of the scale were evaluated between 0.80 and 0.94. The Cronbach Alpha internal consistency coefficient of the scale was 0.947. The scale contains a total of 18 items and is evaluated according to the 5-point Likert system.
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 9 Jul 2026.
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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 Using High Reality Simulator in people with Simulation, run by Ondokuz Mayıs 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 2 inclusion and 2 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 9 Jul 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?
Self-Confidence/Competence in Patient Intervention Scale (time frame: immediately after intervention). 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 9 Jul 2026.