ClinicalTrials.gg
CompletedNCT06681987Updated Dec 27, 2024

Innovative Approaches in Midwifery Education

An interventional study of simulation training in Simulation Training, sponsored by Istanbul University - Cerrahpasa. Completed at 1 site in Turkey (Türkiye). Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-27.

Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Simulation Training

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Keywords

  • pre-eclampsia
  • simulation
  • midwifery
03

In context

Pre-Eclampsia

903 studies on the registry are indexed under Pre-Eclampsia; 240 are open to participants now.

This study's enrollment of 30 is below the median of 110 across 478 interventional studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Istanbul University - Cerrahpasa is the lead sponsor of 694 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • 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.

    Behavioral: simulation training

  • No intervention
    control

    application will be made in a low reality model

Interventions

  • Behavioralsimulation training

    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.

06

What researchers measure

Primary outcomes

  1. Problem Solving skills

    Problem solving skill scores will increase after the intervention.

    Time frame: one day after the training

07

Study locations

1 site
  • Ağrı Ibrahim Çeçen University Faculty of Health Sciences
    Ağrı, Ağrı, Turkey (Türkiye)
08

References and documents

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 ↗

Individual participant data

Plan to share: 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06681987
Responsible party
Betul Uncu (Lecturer, Agri Ibrahim Cecen University) — Principal investigator
First posted
Nov 12, 2024
Start date
Dec 1, 2024
Primary completion
Dec 23, 2024
Completion
Dec 23, 2024
Last update
Dec 27, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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