Accessible Simulation Approaches: The Effect of Portable Three-Dimensional Visual Material-Supported Education on University Students' Knowledge, Satisfaction, and Self-Confidence
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Marmara University
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Change in Cervical Dilatation Assessment Knowledge Test (CDAK) Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: Portable 3D Visual Material-Supported Simulation Training (Behavioral)
Control Group
Participants received the standard theoretical instruction and laboratory education on cervical dilation assessment without the portable three-dimensional educational material.
Intervention: Standard Education (Behavioral)
Outcomes
Primary Outcomes
Change in Cervical Dilatation Assessment Knowledge Test (CDAK) Score
Time Frame: 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)
- Simulation Design Perception(Immediately after completion of the 14-week intervention)
Investigators
Ayşegül Şimşek
Assoc. Prof. Dr.
Marmara University