Brief Title: Portable 3D Visual Material-Supported Simulation Training for Cervical Dilation Assessment
14 lipca 2026 zaktualizowane przez: Ayşegül Şimşek, Marmara University
Accessible Simulation Approaches: The Effect of Portable Three-Dimensional Visual Material-Supported Education on University Students' Knowledge, Satisfaction, and Self-Confidence
This randomized controlled trial aimed to evaluate the effectiveness of simulation-based education supported by a portable and mobile three-dimensional (3D) visual material on university students' knowledge of cervical dilation assessment, learning satisfaction, self-confidence in learning, and perceptions of simulation design.
Undergraduate health sciences students were randomly assigned to either an intervention group receiving simulation training with the portable 3D material in addition to standard education or a control group receiving standard education alone.
The primary outcome was change in knowledge of cervical dilation assessment.
Secondary outcomes included student satisfaction, self-confidence in learning, and perceptions of simulation design.
Przegląd badań
Status
Zakończony
Szczegółowy opis
This study is a parallel-group, 1:1 allocation randomized controlled trial with a pretest-posttest design conducted among third-year undergraduate health sciences students enrolled in the Pregnancy and Care course. Participants were randomly assigned using a computer-generated randomization sequence with allocation concealment through sequentially numbered opaque sealed envelopes.
Both groups received the standard theoretical and laboratory curriculum on cervical dilation assessment. In addition, participants allocated to the intervention group received simulation-based training supported by a portable and foldable three-dimensional cervical dilation educational model designed to facilitate repeated individual practice outside the simulation laboratory. Students practiced with the model seven times throughout the semester using a standardized educational protocol delivered by the same instructor.
The educational material was specifically developed to provide an accessible, reusable, and portable simulation resource that allows repeated psychomotor practice without requiring permanent simulation laboratory access. The study evaluated whether supplementing standard education with repeated practice using the portable three-dimensional model improves educational outcomes compared with standard education alone. The trial was conducted in accordance with the CONSORT reporting guideline, and no protocol modifications were made after trial initiation. Ethical approval and written informed consent were obtained before participant enrollment.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
62
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Istanbul, Turcja (Türkiye), 34854
- Marmara University, Faculty of Health Sciences
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Tak
Opis
Inclusion Criteria:
- Undergraduate student enrolled in the Faculty of Health Sciences
- Enrolled in the Pregnancy and Care course during the study period
- Aged 18 years or older
- Provided written informed consent
Exclusion Criteria:
- Did not participate in any stage of the educational intervention
- Did not complete the post-intervention assessments
- Did not complete the study questionnaires
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Intervention Group
Participants received the standard theoretical and laboratory education plus simulation-based training supported by a portable and mobile three-dimensional visual cervical dilation educational material.
Students practiced with the portable material once every two weeks throughout the semester.
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Simulation-based education supported by a portable and mobile three-dimensional visual educational material designed for cervical dilation assessment.
Participants practiced with the material repeatedly throughout the semester in addition to standard education.
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Aktywny komparator: Control Group
Participants received the standard theoretical instruction and laboratory education on cervical dilation assessment without the portable three-dimensional educational material.
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Standard theoretical instruction and laboratory training on cervical dilation assessment delivered as part of the regular curriculum.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Cervical Dilatation Assessment Knowledge Test (CDAK) Score
Ramy czasowe: Immediately after completion of the 14-week intervention
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Change in knowledge regarding cervical dilation assessment measured using the Cervical Dilatation Assessment Knowledge Test (CDAK).
Developed by the researchers in accordance with the literature.
To assess the test's content validity, it was submitted for review to 10 experts in the field, including academics and healthcare professionals (physicians, midwives, and nurses).
In the test, each correct answer was scored as 1 point, and each incorrect answer as 0 points.
The experts were asked to evaluate the items using a three-point rating scale (1 = Necessary, 2 = Useful but not necessary, 3 = Unnecessary) based on the Lawshe technique.
In addition, experts who selected the "Should be corrected" option were asked to provide suggestions for corrections to the relevant item, while those who selected the "Should be removed" option were asked to provide their reasons for removal.
As a result of the Lawshe technique, the content validity ratio (CVR) was found to be 0.79 (p<0.05).
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Immediately after completion of the 14-week intervention
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Student Satisfaction and Self-Confidence in Learning
Ramy czasowe: Immediately after completion of the 14-week intervention
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Student satisfaction measured using the Student Satisfaction and Self-Confidence in Learning Scale (Satisfaction subscale).
Higher scores indicate greater satisfaction with learning.
Scale was developed in 2006 and adapted into Turkish in 2017.
The scale consists of 12 items and 2 subscales (Satisfaction with current learning = 5 items, Self-confidence in learning = 7 items).
The scale is a five-point Likert type with no reverse-scored items (1 = Strongly Disagree; 5 = Strongly Agree).
The total SSSS score is obtained by dividing the sum of the subscale scores by the number of items.
Higher scores indicate higher satisfaction and self-confidence.
The total Cronbach Alpha value of the scale is reported as 0.95, and in our study, it was found to be 0.95 immediately after the training and 0.95 14 weeks after the training.
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Immediately after completion of the 14-week intervention
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Simulation Design Perception
Ramy czasowe: Immediately after completion of the 14-week intervention
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Students' perceptions of simulation design measured using the Simulation Design Scale (SDS).
Higher scores indicate more positive evaluations of the simulation design.
Scale, developed in 2006 and adapted into Turkish in 2017.
The scale consists of 20 items and 5 subscales (Goals and information=5 items, Support=4 items, Problem Solving=5 items, Feedback=4 items, and Realism=2 items).
The scale is evaluated in two sections.
The first section assesses whether the best simulation design elements are applied in the simulation application.
The second section evaluates the degree to which simulation design elements are important for students.
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Immediately after completion of the 14-week intervention
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Aysegul Simsek, PhD, Marmara University
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
22 stycznia 2024
Zakończenie podstawowe (Rzeczywisty)
14 czerwca 2024
Ukończenie studiów (Rzeczywisty)
14 czerwca 2024
Daty rejestracji na studia
Pierwszy przesłany
10 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
10 lipca 2026
Pierwszy wysłany (Rzeczywisty)
15 lipca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
16 lipca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
14 lipca 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- ISTUNIV-CDA-3D-2024
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .