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

NCT07705503 | Completed

• 1 other identifier: ISTUNIV-CDA-3D-2024
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

Participants received the standard theoretical instruction and laboratory education on cervical dilation assessment without the portable three-dimensional educational material.

Behavioral: Standard Education

Interventions

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.

Intervention Group

Standard Education BEHAVIORAL

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

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Did not participate in any stage of the educational intervention
• Did not complete the post-intervention assessments
• Did not complete the study questionnaires

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University, Faculty of Health Sciences

Istanbul, 34854, Turkey (Türkiye)

Location

Study Officials

• Aysegul Simsek, PhD

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the educational intervention, blinding of participants and instructors was not feasible.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start: January 22, 2024
• Primary Completion: June 14, 2024
• Study Completion: June 14, 2024
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)