Labor; Poor, PrimaryNCT07238205
Mixed Reality Training for Teaching Cervical Effacement and Dilation
A study testing mixed reality education and Standard Education Group in people with Labor; Poor, Primary, run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this educational research is to determine whether a mixed reality-based training program is effective in teaching midwifery students how to assess cervical effacement and dilation. Read more about this study
- Who is it for?
- Ages 18 months to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor; Poor, Primary
- What is being tested?
- mixed reality education and Standard Education Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 months to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Enrolled in the Midwifery Department at Mardin Artuklu University,
- Taking the course "Normal Birth and Postpartum Care,"
- Who have not previously received any structured training (practical training, simulation, etc.) related to vaginal examination or cervical dilation/effacement procedures,
- Who do not feel confident in assessing cervical effacement and dilation,
- Who volunteer to participate in the study will be included,
- Pregnant women who are in the first stage of labor and have no obstetric complications.
Who cannot join
- Individuals who are graduates of health vocational high schools,
- Have disabilities in their eyes, hands, arms, or fingers,
- Those who do not complete the training will not be included.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mardin Training and Research Hospital
Mardin, 47200
Ülkin Gündüz Aruser, Ph.D, +905314592113, ulkingunduz@artuklu.edu.tr
About this study
Official title: The Effect of Mixed Reality Application in Teaching Cervical Effacement and Dilatation on Cognitive Load, Sense of Presence, and Midwifery Professional Perception
The aim of this educational research is to determine whether a mixed reality-based training program is effective in teaching midwifery students how to assess cervical effacement and dilation. The study also examines the impact of mixed reality on students' cognitive load, sense of presence, and midwifery professional perception.
The main questions the study seeks to answer are:
Read more
Does mixed reality training reduce students' cognitive load?
Does mixed reality increase the students' sense of presence?
How does mixed reality-based training influence students' professional perception of midwifery?
Do students who receive mixed reality training perform better in assessing cervical effacement and dilation on real pregnant women compared with the control group?
Read the detailed description
The aim of this educational research is to determine whether a mixed reality-based training program is effective in teaching midwifery students how to assess cervical effacement and dilation. The study also examines the impact of mixed reality on students' cognitive load, sense of presence, and midwifery professional perception.
The main questions the study seeks to answer are:
Does mixed reality training reduce students' cognitive load?
Does mixed reality increase the students' sense of presence?
How does mixed reality-based training influence students' professional perception of midwifery?
Do students who receive mixed reality training perform better in assessing cervical effacement and dilation on real pregnant women compared with the control group?
How the research will be conducted:
Researchers will compare a mixed reality intervention group with a control group receiving traditional training. Students in both groups will evaluate five different pregnant women to assess cervical effacement and dilation in real clinical settings.
Participants will:
Receive either mixed reality-based training (intervention) or traditional instruction (control)
Complete the Cognitive Load Scale, Sense of Presence Scale, and Midwifery Professional Perception Scale
Perform cervical effacement and dilation assessments on five pregnant women during clinical practice
- Conditions
- Labor; Poor, Primary
- Being tested
- mixed reality education, Standard Education Group
- Keywords
- Cervical Dilatation, Labor, First Stage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mixed reality educationOther
Students will participate in a mixed reality (MR)-based training program.
The program is designed to teach cervical effacement and dilation assessment.
During the training, students will interact with three-dimensional virtual cervical models.
They will be able to practice repeatedly in a safe, error-free environment to enhance their clinical skills.
After completing MR training, students will perform vaginal examinations on 10 virtual patient scenarios.
The accuracy of each assessment will be automatically evaluated by the system.
Following MR training, students will conduct vaginal examinations on five pregnant women under researcher supervision in a real clinical setting.
The following scales will be administered to participants:
Cognitive Load Scale
Sense of Presence Scale
Midwifery Professional Perception Scale
These measures will be used to determine the cognitive and professional effects of MR-based learning.
Standard Education GroupOther
Students in the control group will receive traditional theoretical instruction.
The training content will cover the principles of cervical effacement and dilation assessment.
After completing the theoretical training, students will complete the Cognitive Load Scale and the Midwifery Professional Perception Scale.
Under researcher supervision, students will perform vaginal examinations on five pregnant women to assess cervical effacement and dilation.
These evaluations will be used to examine the effects of traditional training on students' cognitive load, professional perception, and practical assessment skills.
| Study group | Role | What they receive |
|---|---|---|
| Mixed Reality Training Group | Experimental | Students will participate in a mixed reality (MR)-based training program. Receives: Other: mixed reality education |
| Standard Education Group | Active comparator | Students in the control group will receive traditional theoretical instruction. Receives: Other: Standard Education Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Cervical Dilation Measurement (cm)
Accuracy of cervical dilation measurement will be assessed by calculating the absolute difference (in centimeters) between the student's measurement and the researcher's reference measurement. Each participant will perform one vaginal examination on five different pregnant women. The mean absolute difference across all five assessments will be reported as the participant's cervical dilation measurement accuracy. Smaller values indicate higher accuracy.
Measured: 4 month
Accuracy of Cervical Effacement Measurement (%)
Cervical effacement accuracy will be assessed by calculating the absolute difference (in percentage points) between the student's effacement measurement and the researcher's reference measurement. Each participant will perform one vaginal examination on five different pregnant women. The mean absolute difference across all five assessments will be reported as the participant's cervical effacement measurement accuracy. Smaller values indicate higher accuracy.
Measured: 4 month
Secondary outcomes (3)
Assessment of Cognitive Load
Cognitive load will be assessed using the Cognitive Load Scale, a 9-point Likert-type measure.
Participants will respond to the question "How much mental effort did you invest in completing the task?" by selecting a score between 1 (low) and 9 (high).
The midpoint of the scale is 5; participants scoring above this value will be considered to have experienced higher levels of cognitive load.
Measured: 4 months
Assessment of Presence Experience
The sense of presence will be assessed using the Presence Scale (PS) adapted to a 5-point Likert scale. Participants will rate their virtual reality experience from 1 (strongly disagree) to 5 (strongly agree). Higher subscale scores indicate that the virtual environment is perceived as more realistic and that the sense of presence is stronger.
Measured: Immediately after MR training (within 1 day)
Assessment of Midwifery Professional Perception
Midwifery professional perception will be assessed using the Midwifery Professional Perception Scale (MPPS). Participants will rate statements reflecting their perceptions of the midwifery profession on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate a more positive perception of the midwifery profession.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Oct 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor; Poor, PrimaryStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel-group controlled trial including an intervention group receiving mixed reality training and a control group receiving standard education.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mardin Artuklu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulkin Gündüz, Mardin Artuklu University
- Investigators
- Ülkin Gündüz Aruser, Ph.D, Principal investigator, Mardin Artuklu UniversityHacer Ünver Koca, Assoc. Prof., Study director, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238205
- Sponsor's protocol ID
- MAU-Midwifery-UG-01
- Status last verified
- Nov 2025
- First submitted
- 12 Sep 2025
- Last updated
- 20 Nov 2025
- 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 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mixed Reality Application in Teaching Cervical Effacement and Dilatation on Cognitive Load, Sense of Presence, and Midwifery Professional Perception
- ClinicalTrials.gov ID
- NCT07238205
- Acronym / sponsor ID
- MAU-Midwifery-UG-01
- Conditions
- Labor; Poor, Primary
- Keywords
- Cervical Dilatation, Labor, First Stage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mardin Artuklu UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 20 Nov 2025 (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.
The aim of this educational research is to determine whether a mixed reality-based training program is effective in teaching midwifery students how to assess cervical effacement and dilation. The study also examines the impact of mixed reality on students' cognitive load, sense of presence, and midwifery professional perception.
The main questions the study seeks to answer are:
Does mixed reality training reduce students' cognitive load?
Does mixed reality increase the students' sense of presence?
How does mixed reality-based training influence students' professional perception of midwifery?
Do students who receive mixed reality training perform better in assessing cervical effacement and dilation on real pregnant women compared with the control group?
Detailed description
The aim of this educational research is to determine whether a mixed reality-based training program is effective in teaching midwifery students how to assess cervical effacement and dilation. The study also examines the impact of mixed reality on students' cognitive load, sense of presence, and midwifery professional perception.
The main questions the study seeks to answer are:
Does mixed reality training reduce students' cognitive load?
Does mixed reality increase the students' sense of presence?
How does mixed reality-based training influence students' professional perception of midwifery?
Do students who receive mixed reality training perform better in assessing cervical effacement and dilation on real pregnant women compared with the control group?
How the research will be conducted:
Researchers will compare a mixed reality intervention group with a control group receiving traditional training. Students in both groups will evaluate five different pregnant women to assess cervical effacement and dilation in real clinical settings.
Participants will:
Receive either mixed reality-based training (intervention) or traditional instruction (control)
Complete the Cognitive Load Scale, Sense of Presence Scale, and Midwifery Professional Perception Scale
Perform cervical effacement and dilation assessments on five pregnant women during clinical practice
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, parallel-group controlled trial including an intervention group receiving mixed reality training and a control group receiving standard education.
| Arm | Type | Receives |
|---|---|---|
| Mixed Reality Training Group | Experimental | Other: mixed reality educationStudents will participate in a mixed reality (MR)-based training program. |
| Standard Education Group | Active comparator | Other: Standard Education GroupStudents in the control group will receive traditional theoretical instruction. |
Who may qualify
- Ages
- 18 months to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Enrolled in the Midwifery Department at Mardin Artuklu University,
- Taking the course "Normal Birth and Postpartum Care,"
- Who have not previously received any structured training (practical training, simulation, etc.) related to vaginal examination or cervical dilation/effacement procedures,
- Who do not feel confident in assessing cervical effacement and dilation,
- Who volunteer to participate in the study will be included,
Key exclusion criteria (3 listed)
- Individuals who are graduates of health vocational high schools,
- Have disabilities in their eyes, hands, arms, or fingers,
- Those who do not complete the training will not be included.
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 |
|---|---|---|
| mixed reality educationStudents will participate in a mixed reality (MR)-based training program. The program is designed to teach cervical effacement and dilation assessment. During the training, students will interact with three-dimensional virtual cervical models. They will be able to practice repeatedly in a safe, error-free environment to enhance their clinical skills. After completing MR training, students will perform vaginal examinations on 10 virtual patient scenarios. The accuracy of each assessment will be automatically evaluated by the system. Following MR training, students will conduct vaginal examinations on five pregnant women under researcher supervision in a real clinical setting. The following scales will be administered to participants: Cognitive Load Scale Sense of Presence Scale Midwifery Professional Perception Scale These measures will be used to determine the cognitive and professional effects of MR-based learning. | Other | Mixed Reality Training Group |
| Standard Education GroupStudents in the control group will receive traditional theoretical instruction. The training content will cover the principles of cervical effacement and dilation assessment. After completing the theoretical training, students will complete the Cognitive Load Scale and the Midwifery Professional Perception Scale. Under researcher supervision, students will perform vaginal examinations on five pregnant women to assess cervical effacement and dilation. These evaluations will be used to examine the effects of traditional training on students' cognitive load, professional perception, and practical assessment skills. | Other | Standard Education Group |
Primary outcome
Accuracy of Cervical Dilation Measurement (cm)
Time frame: 4 month
Accuracy of cervical dilation measurement will be assessed by calculating the absolute difference (in centimeters) between the student's measurement and the researcher's reference measurement. Each participant will perform one vaginal examination on five different pregnant women. The mean absolute difference across all five assessments will be reported as the participant's cervical dilation measurement accuracy. Smaller values indicate higher accuracy.
Accuracy of Cervical Effacement Measurement (%)
Time frame: 4 month
Cervical effacement accuracy will be assessed by calculating the absolute difference (in percentage points) between the student's effacement measurement and the researcher's reference measurement. Each participant will perform one vaginal examination on five different pregnant women. The mean absolute difference across all five assessments will be reported as the participant's cervical effacement measurement accuracy. Smaller values indicate higher accuracy.
3 secondary outcomes
Assessment of Cognitive Load
Time frame: 4 months
Assessment of Presence Experience
Time frame: Immediately after MR training (within 1 day)
Assessment of Midwifery Professional Perception
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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.
Ülkin Gündüz Aruser, Ph.D principal investigator
Mardin Artuklu University
Hacer Ünver Koca, Assoc. Prof. study director
Inonu 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 mixed reality education and Standard Education Group in people with Labor; Poor, Primary, run by Mardin Artuklu 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 6 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: looking for participants now, as of the sponsor's last update on 20 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ülkin Gündüz Aruser, Ph.D (+905314592113, ulkingunduz@artuklu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Cervical Dilation Measurement (cm) (time frame: 4 month). The study lists 2 primary outcomes in all. 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 20 Nov 2025.