Breast Examination Skills Training in Midwifery StudentsMBETNCT07884383
Effect of Mannequin-Assisted Breast Examination Training on Midwifery Students
A study testing Mannequin-Assisted Breast Examination Training and Routine Theoretical Breast Examination Education in people with Breast Examination Skills Training in Midwifery Students, run by Sinop University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study evaluated whether mannequin-assisted breast examination training improves breast examination skills, perceived learning, clinical self-efficacy, and health beliefs among midwifery students. The study included 71 second- and third-year midwifery students at Sinop University. Read more about this study
- Who is it for?
- Ages 17 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Examination Skills Training in Midwifery Students
- What is being tested?
- Mannequin-Assisted Breast Examination Training and Routine Theoretical Breast Examination Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 20 Feb 2026
- 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 17 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Second- or third-year student in the Midwifery Department of the Faculty of Health Sciences at Sinop University
- Willing to participate voluntarily and provide informed consent
- Able to attend the training sessions regularly throughout the study
- No previous comprehensive training in breast examination
- No physical or cognitive condition preventing participation in the study procedures
Who cannot join
- Refusal to provide informed consent
- Physical or cognitive limitation preventing active participation
- Withdrawal from the study at any stage
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sinop University Faculty of Health Sciences
Sinop, Sinop
About this study
Official title: The Effect of Model-Assisted Breast Examination Skills Training on Clinical Self-Efficacy and Health Beliefs
This randomized controlled study evaluated whether mannequin-assisted breast examination training improves breast examination skills, perceived learning, clinical self-efficacy, and health beliefs among midwifery students. The study included 71 second- and third-year midwifery students at Sinop University. Participants were randomly assigned to an intervention group or a control group. Both groups received theoretical education on breast examination. In addition, the intervention group received hands-on training using a breast examination mannequin in a laboratory setting. Outcomes were assessed at baseline, after training, and at follow-up using validated questionnaires and a structured breast examination skills assessment form. The study aimed to determine whether mannequin-assisted training provides additional benefits compared with routine theoretical education.
Read the detailed description
The study was conducted as a prospective, randomized controlled trial with repeated measurements. Participants were second- and third-year students enrolled in the Midwifery Department of the Faculty of Health Sciences at Sinop University.
Eligible students were randomly assigned to either the mannequin-assisted training group or the control group. The control group received routine theoretical education covering preparation for breast examination, inspection, palpation techniques, nipple assessment, evaluation of axillary and supraclavicular lymph nodes, recognition of abnormal findings, and documentation.
The intervention group received the same theoretical content followed by structured hands-on training using a breast examination mannequin in the university skills laboratory. Training was delivered in groups of approximately 10 students. Each participant was given approximately 15 to 20 minutes for individual practice. The practical training included breast examination regions, palpation techniques, nipple assessment, signs suggestive of malignancy, and the complete sequence of breast examination.
Participants were assessed using the Champion Health Belief Model Scale, the Perceived Learning Scale, the Learning Self-Efficacy Scale for Clinical Skills, and a structured Breast Examination Practice Assessment Form. Measurements were obtained at baseline, after the educational intervention, and at follow-up. Breast examination performance was evaluated in the laboratory approximately two weeks after training.
The study compared changes over time between the intervention and control groups in breast examination performance, perceived learning, clinical skills self-efficacy, and beliefs related to breast cancer screening and breast self-examination.
- Being tested
- Mannequin-Assisted Breast Examination Training, Routine Theoretical Breast Examination Education
- Keywords
- Model-assisted training, breast examination, clinical self-efficacy, midwifery students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mannequin-Assisted Breast Examination TrainingOther
Participants received routine theoretical education on breast examination, followed by structured hands-on training using a breast examination mannequin in the laboratory. The training covered breast examination regions, inspection, palpation techniques, nipple assessment, axillary and supraclavicular lymph node examination, recognition of signs suggestive of malignancy, and the complete examination sequence. Training was delivered in groups of approximately 10 students, and each participant practiced individually for approximately 15-20 minutes.
Routine Theoretical Breast Examination EducationOther
Participants received routine theoretical education on breast examination, including preparation, inspection, palpation techniques, nipple assessment, lymph node examination, recognition of abnormal findings, and documentation. No mannequin-assisted practical training was provided.
| Study group | Role | What they receive |
|---|---|---|
| Mannequin-Assisted Breast Examination Training | Experimental | Participants received routine theoretical education on breast examination followed by structured hands-on training using a breast examination mannequin in the laboratory. Training was delivered in groups of approximately 10 students, and each participant practiced individually for approximately 15-20 minutes. Receives: Other: Mannequin-Assisted Breast Examination Training |
| Routine Theoretical Breast Examination Education | Active comparator | Participants received routine theoretical education on breast examination, including patient preparation, inspection, palpation techniques, nipple assessment, lymph node examination, recognition of abnormal findings, and documentation. No mannequin-assisted practical training was provided. Receives: Other: Routine Theoretical Breast Examination Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Skills Self-Efficacy Scale (CSSES) (Learning Self-Efficacy Scale for Clinical Skills)
Clinical skills self-efficacy was assessed using the Turkish version of the Learning Self-Efficacy Scale for Clinical Skills, adapted by Bayazit et al. (2022). The validated Turkish version consists of 14 items following the removal of item 11. It includes three dimensions: cognitive, affective, and psychomotor. Responses are recorded on a five-point Likert scale. The validation article does not explicitly specify the minimum and maximum total scores.
Measured: Baseline (before the educational intervention), immediately after the intervention, and 15 days after the intervention.
Perceived Learning Scale
The Perceived Learning Scale was developed by Rovai and colleagues (2009) to evaluate individuals' perceptions regarding their learning processes and was adapted into Turkish by Albayrak et al. (2014), who conducted its validity and reliability analyses.
The scale, consisting of nine items, includes a three-factor structure covering the cognitive, affective, and psychomotor learning domains. The total score obtainable from the scale ranges from 9 to 63, and it can be completed by participants within an average of 3 to 5 minutes. The Cronbach's alpha coefficient indicating the internal consistency level of the scale was reported as 0.79
Measured: Baseline (before the educational intervention), immediately after the intervention, and 15 days after the intervention.
Champion's Health Belief Model Scale (CHBMS)
Champion's Health Belief Model Scale (CHBMS) was developed by Champion to evaluate individuals' beliefs regarding breast cancer and breast self-examination (BSE). The scale was later updated by adding the subdimensions of mammography benefits and mammography barriers. The Turkish adaptation of the scale was carried out by Gözüm and Aydın (2004). The five-point Likert-type scale consists of 52 items and 8 subdimensions: susceptibility, seriousness, health motivation, BSE benefits, BSE barriers, BSE self-efficacy, mammography benefits, and mammography barriers. The scale consists of 52 items across eight subscales, rated on a five-point Likert scale. The study evaluated both the total scale score and individual subscale scores. The minimum and maximum possible total scores are not specified in the study documentation provided. It has been reported that the Cronbach's alpha coefficients of the scale range between 0.69 and 0.83
Measured: Baseline (before the educational intervention), immediately after the intervention, and 15 days after the intervention.
Breast Examination Practice Evaluation Form (BEPEF)
This form was developed by the researchers through a review of the literature to evaluate midwifery students' skills in performing breast examination. Structured to systematically measure the basic clinical practice steps of breast examination, the form aims to ensure that students perform examination techniques completely and correctly. The BEPEF includes critical components such as the preparation stage of breast examination, inspection (visual assessment), palpation techniques, examination of the nipple and lymph nodes, and recording of pathological findings. The evaluation is scored as "Yes" or "No" according to the performance demonstrated by the midwifery students during the examination.
Measured: 15 days after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Oct 2025
- Primary completion1 Jan 2026
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Examination Skills Training in Midwifery StudentsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to two parallel groups. The intervention group received routine theoretical education followed by mannequin-assisted breast examination skills training in the laboratory. The control group received routine theoretical education only. Outcomes were assessed at baseline, after the intervention, and at follow-up.
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinop University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884383
- Sponsor's protocol ID
- SİNOPU-SİBEL2
- Other IDs
- SGBF-1901-25-003
- Acronym
- MBET
- Status last verified
- Oct 2026
- First submitted
- 27 Jul 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the dataset contains sensitive educational and health-belief information from a small, single-center student population, which may increase the risk of participant identification. Data will be stored securely and used only for the purposes approved by the ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Model-Assisted Breast Examination Skills Training on Clinical Self-Efficacy and Health Beliefs
- ClinicalTrials.gov ID
- NCT07884383
- Acronym / sponsor ID
- MBET / SİNOPU-SİBEL2
- Keywords
- Model-assisted training, breast examination, clinical self-efficacy, midwifery students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Sinop UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 20 Oct 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 study evaluated whether mannequin-assisted breast examination training improves breast examination skills, perceived learning, clinical self-efficacy, and health beliefs among midwifery students. The study included 71 second- and third-year midwifery students at Sinop University. Participants were randomly assigned to an intervention group or a control group. Both groups received theoretical education on breast examination. In addition, the intervention group received hands-on training using a breast examination mannequin in a laboratory setting. Outcomes were assessed at baseline, after training, and at follow-up using validated questionnaires and a structured breast examination skills assessment form. The study aimed to determine whether mannequin-assisted training provides additional benefits compared with routine theoretical education.
Detailed description
The study was conducted as a prospective, randomized controlled trial with repeated measurements. Participants were second- and third-year students enrolled in the Midwifery Department of the Faculty of Health Sciences at Sinop University.
Eligible students were randomly assigned to either the mannequin-assisted training group or the control group. The control group received routine theoretical education covering preparation for breast examination, inspection, palpation techniques, nipple assessment, evaluation of axillary and supraclavicular lymph nodes, recognition of abnormal findings, and documentation.
The intervention group received the same theoretical content followed by structured hands-on training using a breast examination mannequin in the university skills laboratory. Training was delivered in groups of approximately 10 students. Each participant was given approximately 15 to 20 minutes for individual practice. The practical training included breast examination regions, palpation techniques, nipple assessment, signs suggestive of malignancy, and the complete sequence of breast examination.
Participants were assessed using the Champion Health Belief Model Scale, the Perceived Learning Scale, the Learning Self-Efficacy Scale for Clinical Skills, and a structured Breast Examination Practice Assessment Form. Measurements were obtained at baseline, after the educational intervention, and at follow-up. Breast examination performance was evaluated in the laboratory approximately two weeks after training.
The study compared changes over time between the intervention and control groups in breast examination performance, perceived learning, clinical skills self-efficacy, and beliefs related to breast cancer screening and breast self-examination.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to two parallel groups. The intervention group received routine theoretical education followed by mannequin-assisted breast examination skills training in the laboratory. The control group received routine theoretical education only. Outcomes were assessed at baseline, after the intervention, and at follow-up.
| Arm | Type | Receives |
|---|---|---|
| Mannequin-Assisted Breast Examination Training | Experimental | Other: Mannequin-Assisted Breast Examination TrainingParticipants received routine theoretical education on breast examination followed by structured hands-on training using a breast examination mannequin in the laboratory. Training was delivered in groups of approximately 10 students, and each participant practiced individually for approximately 15-20 minutes. |
| Routine Theoretical Breast Examination Education | Active comparator | Other: Routine Theoretical Breast Examination EducationParticipants received routine theoretical education on breast examination, including patient preparation, inspection, palpation techniques, nipple assessment, lymph node examination, recognition of abnormal findings, and documentation. No mannequin-assisted practical training was provided. |
Who may qualify
- Ages
- 17 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Second- or third-year student in the Midwifery Department of the Faculty of Health Sciences at Sinop University
- Willing to participate voluntarily and provide informed consent
- Able to attend the training sessions regularly throughout the study
- No previous comprehensive training in breast examination
- No physical or cognitive condition preventing participation in the study procedures
Key exclusion criteria (3 listed)
- Refusal to provide informed consent
- Physical or cognitive limitation preventing active participation
- Withdrawal from the study at any stage
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 |
|---|---|---|
| Mannequin-Assisted Breast Examination TrainingParticipants received routine theoretical education on breast examination, followed by structured hands-on training using a breast examination mannequin in the laboratory. The training covered breast examination regions, inspection, palpation techniques, nipple assessment, axillary and supraclavicular lymph node examination, recognition of signs suggestive of malignancy, and the complete examination sequence. Training was delivered in groups of approximately 10 students, and each participant practiced individually for approximately 15-20 minutes. | Other | Mannequin-Assisted Breast Examination Training |
| Routine Theoretical Breast Examination EducationParticipants received routine theoretical education on breast examination, including preparation, inspection, palpation techniques, nipple assessment, lymph node examination, recognition of abnormal findings, and documentation. No mannequin-assisted practical training was provided. | Other | Routine Theoretical Breast Examination Education |
Primary outcome
Clinical Skills Self-Efficacy Scale (CSSES) (Learning Self-Efficacy Scale for Clinical Skills)
Time frame: Baseline (before the educational intervention), immediately after the intervention, and 15 days after the intervention.
Clinical skills self-efficacy was assessed using the Turkish version of the Learning Self-Efficacy Scale for Clinical Skills, adapted by Bayazit et al. (2022). The validated Turkish version consists of 14 items following the removal of item 11. It includes three dimensions: cognitive, affective, and psychomotor. Responses are recorded on a five-point Likert scale. The validation article does not explicitly specify the minimum and maximum total scores.
Perceived Learning Scale
Time frame: Baseline (before the educational intervention), immediately after the intervention, and 15 days after the intervention.
The Perceived Learning Scale was developed by Rovai and colleagues (2009) to evaluate individuals' perceptions regarding their learning processes and was adapted into Turkish by Albayrak et al. (2014), who conducted its validity and reliability analyses. The scale, consisting of nine items, includes a three-factor structure covering the cognitive, affective, and psychomotor learning domains. The total score obtainable from the scale ranges from 9 to 63, and it can be completed by participants within an average of 3 to 5 minutes. The Cronbach's alpha coefficient indicating the internal consistency level of the scale was reported as 0.79
Champion's Health Belief Model Scale (CHBMS)
Time frame: Baseline (before the educational intervention), immediately after the intervention, and 15 days after the intervention.
Champion's Health Belief Model Scale (CHBMS) was developed by Champion to evaluate individuals' beliefs regarding breast cancer and breast self-examination (BSE). The scale was later updated by adding the subdimensions of mammography benefits and mammography barriers. The Turkish adaptation of the scale was carried out by Gözüm and Aydın (2004). The five-point Likert-type scale consists of 52 items and 8 subdimensions: susceptibility, seriousness, health motivation, BSE benefits, BSE barriers, BSE self-efficacy, mammography benefits, and mammography barriers. The scale consists of 52 items across eight subscales, rated on a five-point Likert scale. The study evaluated both the total scale score and individual subscale scores. The minimum and maximum possible total scores are not specified in the study documentation provided. It has been reported that the Cronbach's alpha coefficients of the scale range between 0.69 and 0.83
Breast Examination Practice Evaluation Form (BEPEF)
Time frame: 15 days after the intervention.
This form was developed by the researchers through a review of the literature to evaluate midwifery students' skills in performing breast examination. Structured to systematically measure the basic clinical practice steps of breast examination, the form aims to ensure that students perform examination techniques completely and correctly. The BEPEF includes critical components such as the preparation stage of breast examination, inspection (visual assessment), palpation techniques, examination of the nipple and lymph nodes, and recording of pathological findings. The evaluation is scored as "Yes" or "No" according to the performance demonstrated by the midwifery students during the examination.
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 20 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the dataset contains sensitive educational and health-belief information from a small, single-center student population, which may increase the risk of participant identification. Data will be stored securely and used only for the purposes approved by the ethics committee.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mannequin-Assisted Breast Examination Training and Routine Theoretical Breast Examination Education in people with Breast Examination Skills Training in Midwifery Students, run by Sinop 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 5 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 20 Oct 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?
Clinical Skills Self-Efficacy Scale (CSSES) (Learning Self-Efficacy Scale for Clinical Skills) (time frame: Baseline (before the educational intervention), immediately after the intervention, and 15 days after the intervention.). The study lists 4 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 Oct 2026.