NCT06870227

Brief 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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

March 5, 2025

Last Update Submit

February 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    immediately after intervention

Study Arms (2)

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.

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.

Interventions

Using High Reality Simulator will perform emergency eclampsia in labour

High Reality Simulator

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteer to participate in the study
  • Take the Obstetric Emergencies course

You may not qualify if:

  • Not volunteering to participate in the study
  • Not taking the obstetric emergencies course

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayis University

Samsun, 55200, Turkey (Türkiye)

RECRUITING

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
Ph.D.

Study Record Dates

First Submitted

March 5, 2025

First Posted

March 11, 2025

Study Start

December 1, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

February 18, 2026

Record last verified: 2026-02

Locations