Assessment, SelfNCT07705503
Brief Title: Portable 3D Visual Material-Supported Simulation Training for Cervical Dilation Assessment
A study testing Portable 3D Visual Material-Supported Simulation Training and Standard Education in people with Assessment, Self and Simulation-Based Education, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Assessment, Self, Simulation-Based Education
- What is being tested?
- Portable 3D Visual Material-Supported Simulation Training and Standard Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jan 2024to 14 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Did not participate in any stage of the educational intervention
- Did not complete the post-intervention assessments
- Did not complete the study questionnaires
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University, Faculty of Health Sciences
Istanbul, 34854
About this study
Official title: 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.
Read the 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.
- Conditions
- Assessment, Self, Simulation-Based Education
- Being tested
- Portable 3D Visual Material-Supported Simulation Training, Standard Education
- Keywords
- Simulation, Occupational Education, Three-Dimensional Visual Material, Portable Educational Material, Cervical Dilation, Health Sciences Students, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable 3D Visual Material-Supported Simulation TrainingBehavioural
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 EducationBehavioural
Standard theoretical instruction and laboratory training on cervical dilation assessment delivered as part of the regular curriculum.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Immediately after completion of the 14-week intervention
Secondary outcomes (2)
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.
Measured: 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.
Measured: Immediately after completion of the 14-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start22 Jan 2024
- Primary completion14 Jun 2024
- Study completion14 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assessment, SelfStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşegül Şimşek, Marmara University
- Investigators
- Aysegul Simsek, PhD, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705503
- Sponsor's protocol ID
- ISTUNIV-CDA-3D-2024
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accessible Simulation Approaches: The Effect of Portable Three-Dimensional Visual Material-Supported Education on University Students' Knowledge, Satisfaction, and Self-Confidence
- ClinicalTrials.gov ID
- NCT07705503
- Acronym / sponsor ID
- ISTUNIV-CDA-3D-2024
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 14 Jun 2024 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Portable 3D Visual Material-Supported Simulation TrainingParticipants 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. |
| Control Group | Active comparator | Behavioral: Standard EducationParticipants received the standard theoretical instruction and laboratory education on cervical dilation assessment without the portable three-dimensional educational material. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Did not participate in any stage of the educational intervention
- Did not complete the post-intervention assessments
- Did not complete the study questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portable 3D Visual Material-Supported Simulation TrainingSimulation-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. | Behavioural | Intervention Group |
| Standard EducationStandard theoretical instruction and laboratory training on cervical dilation assessment delivered as part of the regular curriculum. | Behavioural | Control Group |
Primary outcome
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).
2 secondary outcomes
Student Satisfaction and Self-Confidence in Learning
Time frame: Immediately after completion of the 14-week intervention
Simulation Design Perception
Time frame: Immediately after completion of the 14-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Assessment, Self
Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Not yet recruiting
A Hybrid Effectiveness-Implementation and Cost-Utility Evaluation of a Support Programme for Informal Carers of People With Dementia in Primary Care (EsCuidar2)
Quality of Life
Recruiting
RIGHTEST iFree 2 CGM System for Glycemic Control in Adults With Diabetes Mellitus
Diabetes (DM)
Not yet recruiting
A Clinical Trial to Evaluate the Effects of the NeuEve Dryness Treatment Kit on Vaginal Health, Comfort, and Quality of Life in Postmenopausal Women
Relieves Vaginal Dryness / Improves Self-Lubrication, Improves Strength & Elasticity of Vagina (Aka Collagen and Elastin)
Recruiting
Mindfulness-based Lifestyle Modification Programme for Caregivers of People With Neurological Disorders
Caregiver
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aysegul Simsek, PhD principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portable 3D Visual Material-Supported Simulation Training and Standard Education in people with Assessment, Self and Simulation-Based Education, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cervical Dilatation Assessment Knowledge Test (CDAK) Score (time frame: Immediately after completion of the 14-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.