Brief Title: Portable 3D Visual Material-Supported Simulation Training for Cervical Dilation Assessment
14 juli 2026 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
62
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Istanbul, Turkiet (Türkiye), 34854
- Marmara University, Faculty of Health Sciences
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
|
|
Aktiv komparator: Control Group
Participants received the standard theoretical instruction and laboratory education on cervical dilation assessment without the portable three-dimensional educational material.
|
Standard theoretical instruction and laboratory training on cervical dilation assessment delivered as part of the regular curriculum.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Cervical Dilatation Assessment Knowledge Test (CDAK) Score
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Student Satisfaction and Self-Confidence in Learning
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Aysegul Simsek, PhD, Marmara University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
22 januari 2024
Primärt slutförande (Faktisk)
14 juni 2024
Avslutad studie (Faktisk)
14 juni 2024
Studieregistreringsdatum
Först inskickad
10 juli 2026
Först inskickad som uppfyllde QC-kriterierna
10 juli 2026
Första postat (Faktisk)
15 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
16 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- ISTUNIV-CDA-3D-2024
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .