Brief Title: Portable 3D Visual Material-Supported Simulation Training for Cervical Dilation Assessment
14 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
62
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Istanbul, Turchia (Türkiye), 34854
- Marmara University, Faculty of Health Sciences
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Cervical Dilatation Assessment Knowledge Test (CDAK) Score
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Student Satisfaction and Self-Confidence in Learning
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Aysegul Simsek, PhD, Marmara University
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
22 gennaio 2024
Completamento primario (Effettivo)
14 giugno 2024
Completamento dello studio (Effettivo)
14 giugno 2024
Date di iscrizione allo studio
Primo inviato
10 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
10 luglio 2026
Primo Inserito (Effettivo)
15 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
16 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
14 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- ISTUNIV-CDA-3D-2024
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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