- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06681987
Innovative Approaches in Midwifery Education
December 23, 2024 updated by: Betul Uncu, Istanbul University - Cerrahpasa
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ağrı, Turkey
- Ağrı Ibrahim Çeçen University Faculty of Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|
|
Experimental: simulation
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.
|
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.
|
|
No Intervention: control
application will be made in a low reality model
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Problem Solving skills
Time Frame: one day after the training
|
Problem solving skill scores will increase after the intervention.
|
one day after the training
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2024
Primary Completion (Actual)
December 23, 2024
Study Completion (Actual)
December 23, 2024
Study Registration Dates
First Submitted
November 6, 2024
First Submitted That Met QC Criteria
November 8, 2024
First Posted (Actual)
November 12, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 23, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-95531838-050.99-116027
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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