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

Accessible Simulation Approaches: The Effect of Portable Three-Dimensional Visual Material-Supported Education on University Students' Knowledge, Satisfaction, and Self-Confidence

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07705503
Enrollment
62
Registered
2026-07-15
Start date
2024-01-22
Completion date
2024-06-14
Last updated
2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Assessment, Self, Simulation-Based Education

Keywords

Simulation, Occupational Education, Three-Dimensional Visual Material, Portable Educational Material, Cervical Dilation, Health Sciences Students, Randomized Controlled Trial

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALPortable 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.

BEHAVIORALStandard Education

Standard theoretical instruction and laboratory training on cervical dilation assessment delivered as part of the regular curriculum.

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Masking description

Due to the nature of the educational intervention, blinding of participants and instructors was not feasible.

Intervention model description

Participants were randomly assigned in a 1:1 ratio to either an intervention group receiving simulation-based education supported by a portable three-dimensional visual material in addition to standard education or a control group receiving standard education alone. Outcomes were assessed using a pretest-posttest design.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Cervical Dilatation Assessment Knowledge Test (CDAK) ScoreImmediately after completion of the 14-week interventionChange 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).

Secondary

MeasureTime frameDescription
Student Satisfaction and Self-Confidence in LearningImmediately after completion of the 14-week interventionStudent 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.
Simulation Design PerceptionImmediately after completion of the 14-week interventionStudents' 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.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORAysegul Simsek, PhD

Marmara University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026