Simulation TrainingNCT06681987
Innovative Approaches in Midwifery Education
A study testing simulation training in people with Simulation Training, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
In midwifery education, simulations often cover areas such as labor and neonatal care, emergency management, birth complications, and routine maternal care. High-reality simulation mannequins allow students to practice a variety of skills, such as managing normal deliveries and complications, providing care during… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Simulation Training
- What is being tested?
- simulation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 23 Dec 2024
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- To agree to participate in the research
- To have successfully passed all courses
- The student does not have visual and hearing impairment problems
- Studying in the 7th academic semester
Who cannot join
- Refusing to participate in the research
- Incomplete/incorrect completion of data collection tools
- Receiving a psychiatric diagnosis such as anxiety disorder
- Excessive stress
- Problems with hand-eye coordination
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ağrı Ibrahim Çeçen University Faculty of Health Sciences
Ağrı, Ağrı
About this study
Official title: Simulation in Preeclampsia and Eclampsia Management: Innovative Approaches in Midwifery Education
In midwifery education, simulations often cover areas such as labor and neonatal care, emergency management, birth complications, and routine maternal care. High-reality simulation mannequins allow students to practice a variety of skills, such as managing normal deliveries and complications, providing care during caesarean section, or performing initial interventions on the newborn. It increases knowledge, critical thinking, confidence and competence, especially in obstetric emergencies where clinical exposure may be limited. Simulation supports the development of both technical and non-technical skills, including teamwork. To be effective, simulation needs to include briefing (feedback), good communication, observation, repetition, reflection and evaluation. However, it remains a valuable tool for creating safe learning environments that mimic real clinical scenarios without patient risk. It helps students practice staying calm and working in an organized manner in the face of stressful situations they may encounter in real life.
Read the detailed description
Instead of the tension and pressure that can be experienced in real patient care, simulations alleviate students' fear of making mistakes by providing a safe environment. This reduces stress and allows students to feel more relaxed. As students have the opportunity to learn from their mistakes and make amends, they can act more confidently when faced with stressful situations. However, it should not be ignored that simulation may cause stress in some students. Since simulations confront students with situations that are close to real clinical scenarios, they may cause students to feel intense pressure, especially in complex or emergency situations. Although there are no real patients in the simulation environment, the realism of the scenarios and the evaluation of their performance by the instructors may increase the stress level in some students. However, this type of stress is usually considered as part of a positive learning process because it allows students to experience less stress when they face similar situations later on. Managing stress during simulation training is also an important part of the training. Post-simulation feedback and evaluation sessions help students to review their emotional and psychological state. This process can help students to evaluate themselves, develop strategies to cope with stress and feel less anxious in the future. In addition, teamwork and collaboration among students during the simulation can also be effective in stress management. Their ability to communicate within the team, receive support and solve problems together contributes to students' relaxation by reducing stress levels.
- Conditions
- Simulation Training
- Being tested
- simulation training
- Keywords
- pre-eclampsia, simulation, midwifery
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simulation trainingBehavioural
One group of students will practice computer-based simulation for pre-eclampsia and eclampsia case management skills using a high-fidelity simulator (n = 15) (subgroups n=3), while the other group will practice with a low-fidelity model (n = 15; subgroups n=3). In the first stage, the case will be written for the high-fidelity simulator and will be submitted to the opinions of experts in the field. After the necessary arrangements are made, the groups will be randomized and allocated. In the second stage, the experimental group will be presented with a virtual reality simulator, and the control group will be presented with a case example of preeclampsia and eclampsia with a low-level simulator. In order to evaluate and increase the teamwork skills of the students in the experimental and control groups, the students will be divided into subgroups of three.
| Study group | Role | What they receive |
|---|---|---|
| simulation | Experimental | One group of students will practice computer-based simulation for pre-eclampsia and eclampsia case management skills using a high-fidelity simulator (n = 15) (subgroups n=3), while the other group will practice with a low-fidelity model (n = 15; subgroups n=3). In the first stage, the case will be written for the high-fidelity simulator and will be submitted to the opinions of experts in the field. After the necessary arrangements are made, the groups will be randomized and allocated. In the second stage, the experimental group will be presented with a virtual reality simulator, and the control group will be presented with a case example of preeclampsia and eclampsia with a low-level simulator. In order to evaluate and increase the teamwork skills of the students in the experimental and control groups, the students will be divided into subgroups of three. Receives: Behavioral: simulation training |
| control | No intervention | application will be made in a low reality model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Problem Solving skills
Problem solving skill scores will increase after the intervention.
Measured: one day after the training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Dec 2024
- Primary completion23 Dec 2024
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Simulation TrainingStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betul Uncu, Agri Ibrahim Cecen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681987
- Sponsor's protocol ID
- E-95531838-050.99-116027
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It may not be appropriate to share data in order to protect participants' privacy and fulfill ethical obligations. As participants do not know that their data will be shared with others, this may violate their privacy.
Publications
Pajohideh ZS, Mohammadi S, Keshmiri F, Jahangirimehr A, Honarmandpour A. The effects of normal vaginal birth simulation training on the clinical skills of midwifery students: a quasi-experiment study. BMC Med Educ. 2023 May 19;23(1):353. doi: 10.1186/s12909-023-04319-9.
PubMed 37208680
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation in Preeclampsia and Eclampsia Management: Innovative Approaches in Midwifery Education
- ClinicalTrials.gov ID
- NCT06681987
- Acronym / sponsor ID
- E-95531838-050.99-116027
- Conditions
- Simulation Training
- Keywords
- pre-eclampsia, simulation, midwifery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 12 Nov 2024 (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.
In midwifery education, simulations often cover areas such as labor and neonatal care, emergency management, birth complications, and routine maternal care. High-reality simulation mannequins allow students to practice a variety of skills, such as managing normal deliveries and complications, providing care during caesarean section, or performing initial interventions on the newborn. It increases knowledge, critical thinking, confidence and competence, especially in obstetric emergencies where clinical exposure may be limited. Simulation supports the development of both technical and non-technical skills, including teamwork. To be effective, simulation needs to include briefing (feedback), good communication, observation, repetition, reflection and evaluation. However, it remains a valuable tool for creating safe learning environments that mimic real clinical scenarios without patient risk. It helps students practice staying calm and working in an organized manner in the face of stressful situations they may encounter in real life.
Detailed description
Instead of the tension and pressure that can be experienced in real patient care, simulations alleviate students' fear of making mistakes by providing a safe environment. This reduces stress and allows students to feel more relaxed. As students have the opportunity to learn from their mistakes and make amends, they can act more confidently when faced with stressful situations. However, it should not be ignored that simulation may cause stress in some students. Since simulations confront students with situations that are close to real clinical scenarios, they may cause students to feel intense pressure, especially in complex or emergency situations. Although there are no real patients in the simulation environment, the realism of the scenarios and the evaluation of their performance by the instructors may increase the stress level in some students. However, this type of stress is usually considered as part of a positive learning process because it allows students to experience less stress when they face similar situations later on. Managing stress during simulation training is also an important part of the training. Post-simulation feedback and evaluation sessions help students to review their emotional and psychological state. This process can help students to evaluate themselves, develop strategies to cope with stress and feel less anxious in the future. In addition, teamwork and collaboration among students during the simulation can also be effective in stress management. Their ability to communicate within the team, receive support and solve problems together contributes to students' relaxation by reducing stress levels.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| simulation | Experimental | Behavioral: simulation trainingOne group of students will practice computer-based simulation for pre-eclampsia and eclampsia case management skills using a high-fidelity simulator (n = 15) (subgroups n=3), while the other group will practice with a low-fidelity model (n = 15; subgroups n=3). In the first stage, the case will be written for the high-fidelity simulator and will be submitted to the opinions of experts in the field. After the necessary arrangements are made, the groups will be randomized and allocated. In the second stage, the experimental group will be presented with a virtual reality simulator, and the control group will be presented with a case example of preeclampsia and eclampsia with a low-level simulator. In order to evaluate and increase the teamwork skills of the students in the experimental and control groups, the students will be divided into subgroups of three. |
| control | No intervention | –application will be made in a low reality model |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- To agree to participate in the research
- To have successfully passed all courses
- The student does not have visual and hearing impairment problems
- Studying in the 7th academic semester
Key exclusion criteria (5 listed)
- Refusing to participate in the research
- Incomplete/incorrect completion of data collection tools
- Receiving a psychiatric diagnosis such as anxiety disorder
- Excessive stress
- Problems with hand-eye coordination
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 |
|---|---|---|
| simulation trainingOne group of students will practice computer-based simulation for pre-eclampsia and eclampsia case management skills using a high-fidelity simulator (n = 15) (subgroups n=3), while the other group will practice with a low-fidelity model (n = 15; subgroups n=3). In the first stage, the case will be written for the high-fidelity simulator and will be submitted to the opinions of experts in the field. After the necessary arrangements are made, the groups will be randomized and allocated. In the second stage, the experimental group will be presented with a virtual reality simulator, and the control group will be presented with a case example of preeclampsia and eclampsia with a low-level simulator. In order to evaluate and increase the teamwork skills of the students in the experimental and control groups, the students will be divided into subgroups of three. | Behavioural | simulation |
Primary outcome
Problem Solving skills
Time frame: one day after the training
Problem solving skill scores will increase after the intervention.
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 27 Dec 2024.
- Background: PubMed 37208680Pajohideh ZS, Mohammadi S, Keshmiri F, Jahangirimehr A, Honarmandpour A. The effects of normal vaginal birth simulation training on the clinical skills of midwifery students: a quasi-experiment study. BMC Med Educ. 2023 May 19;23(1):353. doi: 10.1186/s12909-023-04319-9.
- Individual participant dataSharing planned: No. It may not be appropriate to share data in order to protect participants' privacy and fulfill ethical obligations. As participants do not know that their data will be shared with others, this may violate their privacy.
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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 simulation training in people with Simulation Training, run by Istanbul University - Cerrahpasa 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 4 inclusion and 5 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 27 Dec 2024. 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?
Problem Solving skills (time frame: one day after the training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06681987, which also lists 1 linked publication.
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 27 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.