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Brief Title: Portable 3D Visual Material-Supported Simulation Training for Cervical Dilation Assessment

14. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

62

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Türkei (türkiye)
      • Istanbul, Türkei (türkiye), 34854
        • Marmara University, Faculty of Health Sciences

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verhalten: Portable 3D Visual Material-Supported Simulation Training
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.
Aktiver Komparator: Control Group
Participants received the standard theoretical instruction and laboratory education on cervical dilation assessment without the portable three-dimensional educational material.
Verhalten: Standard Education
Standard theoretical instruction and laboratory training on cervical dilation assessment delivered as part of the regular curriculum.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Cervical Dilatation Assessment Knowledge Test (CDAK) Score
Zeitfenster: Immediately after completion of the 14-week intervention
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).
Immediately after completion of the 14-week intervention

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Student Satisfaction and Self-Confidence in Learning
Zeitfenster: Immediately after completion of the 14-week intervention
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.
Immediately after completion of the 14-week intervention
Simulation Design Perception
Zeitfenster: Immediately after completion of the 14-week intervention
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.
Immediately after completion of the 14-week intervention

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Marmara University

Ermittler

  • Hauptermittler: Aysegul Simsek, PhD, Marmara University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

22. Januar 2024

Primärer Abschluss (Tatsächlich)

14. Juni 2024

Studienabschluss (Tatsächlich)

14. Juni 2024

Studienanmeldedaten

Zuerst eingereicht

10. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Juli 2026

Zuerst gepostet (Tatsächlich)

15. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • ISTUNIV-CDA-3D-2024

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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