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

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.

• Portable 3D Visual Material-Supported Simulation Training (Behavioral): 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.
• Standard Education (Behavioral): Standard theoretical instruction and laboratory training on cervical dilation assessment delivered as part of the regular curriculum.

Primary outcomes

• Change in Cervical Dilatation Assessment Knowledge Test (CDAK) Score [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).

Secondary outcomes

• Student Satisfaction and Self-Confidence in Learning [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.
• Simulation Design Perception [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.

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

• Aysegul Simsek, PhD, Principal investigator, Marmara University