NCT06681987

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2024

Completed
Last Updated

December 27, 2024

Status Verified

November 1, 2024

Enrollment Period

22 days

First QC Date

November 6, 2024

Last Update Submit

December 23, 2024

Conditions

Keywords

pre-eclampsiasimulationmidwifery

Outcome Measures

Primary Outcomes (1)

  • Problem Solving skills

    Problem solving skill scores will increase after the intervention.

    one day after the training

Study Arms (2)

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.

Behavioral: simulation training

control

NO INTERVENTION

application will be made in a low reality model

Interventions

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.

simulation

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsmidwifery students are girls.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ağrı Ibrahim Çeçen University Faculty of Health Sciences

Ağrı, Ağrı, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 37208680BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 6, 2024

First Posted

November 12, 2024

Study Start

December 1, 2024

Primary Completion

December 23, 2024

Study Completion

December 23, 2024

Last Updated

December 27, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

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.

Locations