NCT07567430

Brief Summary

Preeclampsia and eclampsia are among the leading causes of maternal death and morbidity, and are obstetric emergencies that lead to serious complications during pregnancy. Preeclampsia affects 2-8% of pregnancies worldwide; approximately 46,000 maternal deaths and approximately 500,000 fetal or neonatal deaths occur annually due to preeclampsia. This situation highlights the importance of well-equipped midwifery care, especially in terms of early diagnosis, accurate assessment, emergency intervention, and effective management. Traditional teaching methods alone are insufficient for midwifery students to develop clinical decision-making skills in life-threatening situations such as preeclampsia and eclampsia, and to translate theoretical knowledge into practice. Therefore, new teaching approaches that support active learning, interaction, and decision-making processes in education are needed. In recent years, digital game-based learning has emerged as an innovative tool in health education with its potential to attract learners' attention, improve problem-solving skills, and increase their motivation. Especially for midwifery students, digital games facilitate experiential learning by providing a safe simulation environment in preparation for information overload and stressful clinical environments. However, the use of digital games in teaching complex clinical processes such as preeclampsia and eclampsia management has been researched to a limited extent. Scientifically examining the effects of such innovative methods on students' learning motivation, attitude, and active participation in the learning process in midwifery education will fill an important gap in the literature. In this context, evaluating digital game-based learning in preeclampsia-eclampsia management education by comparing it with simulation training and traditional teaching will make a significant contribution to both the midwifery education literature and the knowledge base regarding the use of technology in health education.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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 26, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

March 26, 2026

Last Update Submit

May 3, 2026

Conditions

Keywords

digital game based learningpreeclampsiaeclampsiamidwifery education

Outcome Measures

Primary Outcomes (2)

  • CHANGES IN KNOWLEDGE LEVEL SCORE REGARDING PREECLAMPSIA AND ECLAMPSIA MANAGEMENT

    Description: The primary outcome measure of this study is the change in the knowledge level of midwifery students regarding the management of preeclampsia and eclampsia. Knowledge level will be assessed using the Preeclampsia and Eclampsia Management Knowledge Test developed by the researcher. The test is scored on a scale of 0-100 points. Higher scores indicate a higher knowledge level. The knowledge test will be administered to all participants: before the intervention (baseline), immediately after the intervention, and again 4 weeks after the intervention. The analysis will evaluate the difference between the pre-test, post-test, and control test (4 weeks after the intervention) scores.

    6-8 weeks

  • CHANGES IN ATTITUDE SCORES TOWARDS PREECLAMPSIA AND ECLAMPSIA MANAGEMENT

    Description: One of the key outcome measures of this study is the change in midwifery students' professional attitudes towards the management of preeclampsia and eclampsia. The level of attitude will be assessed using the Attitude Scale Towards Preeclampsia and Eclampsia Management, developed by the researcher. The scale is scored between 20 and 100 points. Higher scores indicate a more positive professional attitude. The scale will be administered to all participants: before the intervention (baseline), immediately after the completion of the intervention, and 4 weeks after the completion of the intervention. In the analysis, the difference between the pre-test, post-test, and control test (4 weeks after the completion of the intervention) scores will be evaluated. Time Frame: Before the intervention, immediately after the completion of the intervention (0 weeks), and 4 weeks after the completion of the intervention

    6-8 weeks

Study Arms (3)

traditional education

ACTIVE COMPARATOR

In the traditional approach to preeclampsia management, standard face-to-face lectures, presentations, and guidebooks are used. This method is classically lecture-focused, with students in a passive listening position. Interaction is generally limited. This approach represents the most basic and traditional form of education.

Behavioral: TRADITIONAL TRAINING

simulation training

EXPERIMENTAL

In the simulation training component, preeclampsia management is simulated with clinical scenarios that closely resemble real life. Students have the opportunity to practice critical situations firsthand using simulation mannequins or virtual environments. This method reinforces practical skills, provides immediate feedback, and strengthens students' clinical decision-making abilities. Simulation ensures safe learning by providing experience in a controlled environment.

Behavioral: SIMULATION TRAINING

DIGITAL GAME-BASED EDUCATION

EXPERIMENTAL

In the digital game-based education component, preeclampsia management is presented through a gamification approach. Students actively participate in the learning process through interactive scenarios, problem-solving, and tasks. This method encourages learning in a fun and motivating environment. Progress, feedback, and competition elements in the game increase student engagement and strengthen their learning motivation. This component offers a modern and technology-focused learning experience.

Behavioral: DIGITAL GAME-BASED EDUCATION

Interventions

This intervention encompasses an educational program that presents content on the management of preeclampsia and eclampsia using a digital gamification approach. The training is conducted through a digital game platform developed by the researcher. Participants actively engage in the learning process through interactive tasks, decision-making processes, and problem-solving activities based on clinical scenarios. The game content covers the definition of preeclampsia and eclampsia, risk factors, clinical findings, diagnostic criteria, and management steps. The intervention utilizes: a level-based structure that monitors participant progress, instant feedback mechanisms, and a task completion and achievement-based scoring system. These elements aim to increase learning motivation and support knowledge acquisition. This intervention represents an innovative and technology-based educational approach to be compared with other training methods used in the study

DIGITAL GAME-BASED EDUCATION

Preeclampsia and eclampsia management is simulated through highly realistic clinical scenarios. Students have the opportunity to actively intervene in clinical situations using simulation mannequins. Simulation applications include patient assessment, diagnosis, appropriate intervention planning, and clinical decision-making processes. Participants take an active role during the application and experience scenario-based learning. This method aims to develop practical skills, increase clinical decision-making competence, and reinforce learning in a controlled and safe environment.

simulation training

This intervention comprises standard theoretical training on the management of preeclampsia and eclampsia. Training is conducted through face-to-face lectures, presentations (PowerPoint), and clinical practice guidebooks. Students passively receive information in this instructor-centered process, with limited interaction. The training content covers the definition of preeclampsia and eclampsia, risk factors, clinical findings, diagnostic criteria, complications, and management steps. This intervention represents a standard control approach for comparison with other training methods used in the study.

traditional education

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being an undergraduate midwifery student (4th year).
  • Giving written consent to the study.

You may not qualify if:

  • Having previously received advanced training or clinical assignment in preeclampsia/eclampsia management.
  • Regularly using a similar digital game developed on the subject.
  • Health or cognitive limitations that prevent continuation of the research process (according to the student's statement).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Istanbul, 34083, Turkey (Türkiye)

Location

Related Publications (4)

  • Odame-Amoabeng S, Akalin A, D'haenens F, Tricas-Sauras S, Chang YS. Immersive insights: A qualitative systematic review and thematic synthesis of views, experiences, health and wellbeing of students and educators using virtual reality in nursing and midwifery education. Nurse Educ Today. 2025 Jul;150:106679. doi: 10.1016/j.nedt.2025.106679. Epub 2025 Mar 11.

    PMID: 40112463BACKGROUND
  • Mikkonen K, Liaw SY, Spirgiene L, Subocius A, Ignatavicius P, Blazauskas T, Riklikiene O. Multidimensional pedagogical framework for interprofessional education: Blending classroom, high fidelity and extended reality simulation. Nurse Educ Today. 2025 Nov;154:106838. doi: 10.1016/j.nedt.2025.106838. Epub 2025 Jul 29.

    PMID: 40773797BACKGROUND
  • Gray M, Downer T, Hartz D, Andersen P, Hanson J, Gao Y. The impact of three-dimensional visualisation on midwifery student learning, compared with traditional education for teaching the third stage of labour: A pilot randomised controlled trial. Nurse Educ Today. 2022 Jan;108:105184. doi: 10.1016/j.nedt.2021.105184. Epub 2021 Oct 23.

    PMID: 34717099BACKGROUND
  • Chen SH, Lin BB, Wang XY, Xu GR, Song JH. Construction and implementation of a comprehensive midwifery skills practice course based on scenario simulation teaching: An action research. Nurse Educ Today. 2025 Sep;152:106754. doi: 10.1016/j.nedt.2025.106754. Epub 2025 Apr 17.

    PMID: 40288241BACKGROUND

MeSH Terms

Conditions

Pre-EclampsiaEclampsia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 26, 2026

First Posted

May 5, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

January 30, 2027

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations