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

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.

Study Overview

• Status: Completed
• Conditions: Assessment, Self; Simulation-Based Education
• Intervention / Treatment: Behavioral: Portable 3D Visual Material-Supported Simulation Training; Behavioral: Standard Education

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34854
    • Marmara University, Faculty of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.
Active Comparator: Control Group; Participants received the standard theoretical instruction and laboratory education on cervical dilation assessment without the portable three-dimensional educational material.	Behavioral: Standard Education; Standard theoretical instruction and laboratory training on cervical dilation assessment delivered as part of the regular curriculum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cervical Dilatation Assessment Knowledge Test (CDAK) Score	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Student Satisfaction and Self-Confidence in Learning	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	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

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Principal Investigator: Aysegul Simsek, PhD, Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2024
• Primary Completion (Actual): June 14, 2024
• Study Completion (Actual): June 14, 2024

Study Registration Dates

• First Submitted: July 10, 2026
• First Submitted That Met QC Criteria: July 10, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Simulation; Cervical Dilation; Health Sciences Students; Occupational Education; Three-Dimensional Visual Material; Portable Educational Material
• Other Study ID Numbers: ISTUNIV-CDA-3D-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No