Breast Self-ExaminationNCT06777745
Model Supported Breast Examination Training for Midwifery Students
A study testing Model-assisted breast examination application in people with Breast Self-Examination and Midwifery Students Education, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
Breast cancer is the most common cancer among women worldwide and early detection significantly improves treatment success. Screening methods used for early detection include breast self-examination (BSE), clinical breast examination (CBE) and mammography. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Self-Examination, Midwifery Students Education, Clinical Competence
- What is being tested?
- Model-assisted breast examination application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2025to 15 Aug 2025
- 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 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being a 2nd, 3rd or 4th year midwifery student at Karabük University Faculty of Health Sciences
- Being between the ages of 18-25
- Voluntarily agreeing to participate in the study
- Being a citizen of the Republic of Turkey
Who cannot join
- Leave whenever you want without working.
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
Karabuk University
Karabük, Centre, 78600
Karabuk University Merve, Assistant Professor, +905464156469, mrv_karacali@hotmail.com
About this study
Official title: Improvement of Breast Examination Skills of Midwifery Students: Model Supported Education Study
Breast cancer is the most common cancer among women worldwide and early detection significantly improves treatment success. Screening methods used for early detection include breast self-examination (BSE), clinical breast examination (CBE) and mammography. It is critical for midwifery students to learn CCM and teach this method to women. CPM allows women to recognise early signs through breast self-examination. This method is simple and inexpensive and can be applied without requiring much time and labour. Practical training of midwifery students helps them to ensure the effectiveness and correct application of this method. The use of breast examination models during the training process gives students practical experience in detecting signs of breast cancer, such as nipple depression, discharge, asymmetry of the breasts and the appearance of orange peel. In addition, midwifery students can develop their clinical skills by having the opportunity to make mistakes and gain hands-on experience in a safe environment. This process can contribute to increasing early diagnosis rates and improving treatment processes.The sample of this pre-test, post-test, follow-up randomised controlled study consisted of 64 midwifery students (experimental=32, and control=32). Data will be collected with Personal Information Form (PIF), Breast Examination Skills Assessment Form (BESAF), Self-Confidence Scale (SC) and Student Satisfaction and Confidence in Learning Scale (SCSLS). After obtaining the consent of the students in the experimental group, pre-test data will be obtained by filling out the 'Personal Information Form', 'Self-Confidence Scale' and 'Student Satisfaction and Confidence in Learning Scale'. Then, theoretical information will be given and the examination stages such as determining the area to be examined, manual examination of the area, examination method, nipple examination and detection of malignant formations in the breast will be explained practically in the breast examination model in the laboratory environment. Students will be taken in groups of 10, and after the application is explained, each student will perform the breast examination and evaluation individually. Approximately 15 minutes will be allocated for each student. Two weeks after the breast model application, the same students will be taken to the laboratory and asked to perform all the examination steps again. While the students are performing the examination steps, the researcher will mark the complete and incomplete applications on the 'Breast Examination Skill Evaluation Form' and the missing steps will be explained to the students and they will be asked to complete them. At the same time, 'Self-confidence Scale' and 'Student Satisfaction and Confidence in Learning Scale' will be filled out for the post-test. Then, two weeks later, the 'Self-Confidence Scale' and 'Student Satisfaction and Confidence in Learning Scale' will be filled out again for the final post-test. After obtaining the consent of the students in the control group, pre-test data will be collected by applying 'Personal Information Form', 'Self-Confidence Scale' and 'Student Satisfaction and Confidence in Learning Scale' to the students. Then, the students will be given theoretical information and a video will be shown to them, which includes examination stages such as determining the area to be examined, manual examination of the area, examination method, nipple examination and detection of malignant formations in the breast.
Two weeks later, the students will be taken to the laboratory environment and will be asked to perform the application steps in line with the theoretical course they have taken. While the students are performing the examination steps, the researcher will mark the complete and incomplete applications on the 'Breast Examination Skill Evaluation Form', then the missing steps will be explained to the students and they will be asked to complete them. In the post-test phase, the 'Self-Confidence Scale' and the 'Student Satisfaction and Confidence in Learning Scale' will be administered to the students again. Two weeks after this process, the same scales will be filled in again for the final post-test.
Read the detailed description
Early diagnosis of breast cancer, one of the most common cancers worldwide, significantly enhances the success of treatment. It is crucial for midwifery students to learn breast self-examination and teach this technique to women. This study introduces an innovative approach to address the lack of practical experience among midwifery students. Breast examination mock-ups offer students the opportunity to practice in a safe and controlled environment, enabling them to apply their theoretical knowledge in practice. This contributes to enhancing students' clinical skills and improving their effectiveness in patient care. Moreover, the study aims to improve the quality of midwifery education by providing an effective solution to the challenges posed by limited resources and the increasing number of midwifery students.
By offering students the chance to practice in a secure environment, this study is expected to help midwifery students develop their skills and cope with the lack of clinical experience. The study aims to assess the use of breast examination models as a solution to this practical experience gap, providing students with an opportunity to refine their skills and enhance their clinical competence. The sample of this pre-test, post-test, follow-up randomised controlled study consisted of 64 midwifery students (experimental=32, and control=32). Data will be collected with Personal Information Form (PIF), Breast Examination Skills Assessment Form (BESAF), Self-Confidence Scale (SC) and Student Satisfaction and Confidence in Learning Scale (SCSLS). After obtaining the consent of the students in the experimental group, pre-test data will be obtained by filling out the 'Personal Information Form', 'Self-Confidence Scale' and 'Student Satisfaction and Confidence in Learning Scale'. Then, theoretical information will be given and the examination stages such as determining the area to be examined, manual examination of the area, examination method, nipple examination and detection of malignant formations in the breast will be explained practically in the breast examination model in the laboratory environment. Students will be taken in groups of 10, and after the application is explained, each student will perform the breast examination and evaluation individually. Approximately 15 minutes will be allocated for each student. Two weeks after the breast model application, the same students will be taken to the laboratory and asked to perform all the examination steps again. While the students are performing the examination steps, the researcher will mark the complete and incomplete applications on the 'Breast Examination Skill Evaluation Form' and the missing steps will be explained to the students and they will be asked to complete them. At the same time, 'Self-confidence Scale' and 'Student Satisfaction and Confidence in Learning Scale' will be filled out for the post-test. Then, two weeks later, the 'Self-Confidence Scale' and 'Student Satisfaction and Confidence in Learning Scale' will be filled out again for the final post-test. After obtaining the consent of the students in the control group, pre-test data will be collected by applying 'Personal Information Form', 'Self-Confidence Scale' and 'Student Satisfaction and Confidence in Learning Scale' to the students. Then, the students will be given theoretical information and a video will be shown to them, which includes examination stages such as determining the area to be examined, manual examination of the area, examination method, nipple examination and detection of malignant formations in the breast.
Two weeks later, the students will be taken to the laboratory environment and will be asked to perform the application steps in line with the theoretical course they have taken. While the students are performing the examination steps, the researcher will mark the complete and incomplete applications on the 'Breast Examination Skill Evaluation Form', then the missing steps will be explained to the students and they will be asked to complete them. In the post-test phase, the 'Self-Confidence Scale' and the 'Student Satisfaction and Confidence in Learning Scale' will be administered to the students again. Two weeks after this process, the same scales will be filled in again for the final post-test.
This study presents an innovative approach to supporting midwifery students in developing their clinical skills. The use of breast examination models enables students to better prepare for real clinical situations by applying theoretical knowledge. It is anticipated that students in the experimental group will exhibit higher levels of self-confidence and skill development compared to the control group. These findings could provide valuable data to promote the widespread adoption of model-assisted education in clinical training programs. Given the increasing number of students and the limitations of clinical facilities, model-assisted education emerges as a sustainable and effective solution to enhance the quality of midwifery programs. This method allows students to develop their skills without compromising patient safety and offers flexibility in the educational process. The study's results are expected to guide the structuring of educational programs in midwifery and other healthcare fields.
- Conditions
- Breast Self-Examination, Midwifery Students Education, Clinical Competence, Self-Confidence
- Being tested
- Model-assisted breast examination application
- Keywords
- Midwife, student, breast examination, model
- Medical subject headings
- Breast Self-Examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Model-assisted breast examination applicationOther
Designed for the development of self-examination skills, this model is in the shape of a female upper body with medium-sized breasts. Thanks to its ergonomic design, it can be worn easily and offers a comfortable use. Made of high quality, dermatologically tested and tactile silicone material. This model, which reflects all the details of the skin realistically, has a structure suitable for standing and lying examination. For educational use, there are 2 benign tumours, 4 malignant tumours and 2 typical anomalies. This model allows for practical explanation of all stages of breast examination such as determining the area to be examined, manual examination of the area, examination method, nipple examination and detection of malignant formations in the breast.
| Study group | Role | What they receive |
|---|---|---|
| Model-assisted breast examination application | Experimental | After obtaining consent from the students in the experimental group, pre-test data will be collected by filling out the 'Personal Information Form,' 'Self-Confidence Scale,' and 'Student Satisfaction and Confidence in Learning Scale. After the theoretical information is given, the examination stages will be shown practically on the breast examination model in the laboratory environment. Students taken in groups of 10 will be examined and evaluated one by one after the lecture; 15 minutes will be allocated to each student. Two weeks later, the students will reapply all the examination steps in the laboratory, and the missing steps will be identified and completed by the researcher. In this process, 'Self-Confidence Scale' and 'Student Satisfaction and Confidence in Learning Scale' will be completed for the post-test. Two weeks later, the same scales will be applied again for the final post-test. Receives: Other: Model-assisted breast examination application |
| Control group | No intervention | After obtaining consent from the control group students, pre-test data will be collected using the 'Personal Information Form,' 'Self-Confidence Scale,' and 'Student Satisfaction and Confidence in Learning Scale.' Students will then receive theoretical instruction and watch a video detailing examination stages, including identifying the area, manual examination, examination methods, nipple evaluation, and detecting malignant formations. Two weeks later, students will practice the steps in a laboratory setting based on the theoretical course. During the examination, the researcher will use the 'Breast Examination Skill Assessment Form' to note complete and incomplete steps, explain missing steps, and have students complete them. The 'Self-Confidence Scale' and 'Student Satisfaction and Confidence in Learning Scale' will be re-administered as a post-test. Two weeks later, the same scales will be used for a final post-test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-confidence Scale
Self-Confidence Scale is a 33-item Likert-type scale developed by Akın (2007) to assess the self-confidence level of individuals. The scale consists of two sub-dimensions: internal self-confidence and external self-confidence. The items are scored between 1 (Never) and 5 (Always). The total score ranges from 33 to 165, with higher scores indicating higher self-confidence. Self-confidence level is evaluated by dividing the total score by the number of items: Below 2.5 is considered low self-confidence, between 2.5-3.5 is considered medium self-confidence and above 3.5 is considered high self-confidence.
Measured: 2 mounth
Student Satisfaction and Confidence in Learning Scale
The 'Student Satisfaction and Confidence in Learning Scale' developed to measure students' attitudes and beliefs about simulation was published by the National League for Nurses. The internal consistency coefficient of the scale, whose Turkish validity and reliability was performed by Karaçay and Kaya in 2017, was found to be 0.88. The scale has two sub-dimensions as 'satisfaction with learning' and 'self-confidence' and the total number of items is 13. The scale is answered in a five-point Likert scale. The minimum score obtained from the scale is 17 and the maximum score is 61.
Measured: 2 mounth
Breast Examination Skill Assessment Form
The form prepared by the researchers to evaluate the participants' breast self-examination skills comprehensively includes the steps, techniques and points to be considered during breast examination. The form includes questions to evaluate the basic stages of breast examination such as observation, palpation (palpation), symmetry control, nipple examination, detection of masses or suspicious formations. In this way, the level of correct and complete application of the participants during breast examination is evaluated.
Measured: 3 mounth
Personal Information Form
The form containing questions about the socio-demographic data of the participants was prepared by the researchers.
Measured: 2 mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start15 Jan 2025 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Self-ExaminationStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve AKINCI, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777745
- Sponsor's protocol ID
- E-77192459-050.99-376938
- Other IDs
- KBÜBAP-24-ABP-160
- Status last verified
- Jan 2025
- First submitted
- 20 Dec 2024
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Breast Examination Skills of Midwifery Students: Model Supported Education Study
- ClinicalTrials.gov ID
- NCT06777745
- Acronym / sponsor ID
- E-77192459-050.99-376938
- Conditions
- Breast Self-Examination, Midwifery Students Education, Clinical Competence, Self-Confidence
- Keywords
- Midwife, student, breast examination, model
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 16 Jan 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.
Breast cancer is the most common cancer among women worldwide and early detection significantly improves treatment success. Screening methods used for early detection include breast self-examination (BSE), clinical breast examination (CBE) and mammography. It is critical for midwifery students to learn CCM and teach this method to women. CPM allows women to recognise early signs through breast self-examination. This method is simple and inexpensive and can be applied without requiring much time and labour. Practical training of midwifery students helps them to ensure the effectiveness and correct application of this method. The use of breast examination models during the training process gives students practical experience in detecting signs of breast cancer, such as nipple depression, discharge, asymmetry of the breasts and the appearance of orange peel. In addition, midwifery students can develop their clinical skills by having the opportunity to make mistakes and gain hands-on experience in a safe environment. This process can contribute to increasing early diagnosis rates and improving treatment processes.The sample of this pre-test, post-test, follow-up randomised controlled study consisted of 64 midwifery students (experimental=32, and control=32). Data will be collected with Personal Information Form (PIF), Breast Examination Skills Assessment Form (BESAF), Self-Confidence Scale (SC) and Student Satisfaction and Confidence in Learning Scale (SCSLS). After obtaining the consent of the students in the experimental group, pre-test data will be obtained by filling out the 'Personal Information Form', 'Self-Confidence Scale' and 'Student Satisfaction and Confidence in Learning Scale'. Then, theoretical information will be given and the examination stages such as determining the area to be examined, manual examination of the area, examination method, nipple examination and detection of malignant formations in the breast will be explained practically in the breast examination model in the laboratory environment. Students will be taken in groups of 10, and after the application is explained, each student will perform the breast examination and evaluation individually. Approximately 15 minutes will be allocated for each student. Two weeks after the breast model application, the same students will be taken to the laboratory and asked to perform all the examination steps again. While the students are performing the examination steps, the researcher will mark the complete and incomplete applications on the 'Breast Examination Skill Evaluation Form' and the missing steps will be explained to the students and they will be asked to complete them. At the same time, 'Self-confidence Scale' and 'Student Satisfaction and Confidence in Learning Scale' will be filled out for the post-test. Then, two weeks later, the 'Self-Confidence Scale' and 'Student Satisfaction and Confidence in Learning Scale' will be filled out again for the final post-test. After obtaining the consent of the students in the control group, pre-test data will be collected by applying 'Personal Information Form', 'Self-Confidence Scale' and 'Student Satisfaction and Confidence in Learning Scale' to the students. Then, the students will be given theoretical information and a video will be shown to them, which includes examination stages such as determining the area to be examined, manual examination of the area, examination method, nipple examination and detection of malignant formations in the breast.
Two weeks later, the students will be taken to the laboratory environment and will be asked to perform the application steps in line with the theoretical course they have taken. While the students are performing the examination steps, the researcher will mark the complete and incomplete applications on the 'Breast Examination Skill Evaluation Form', then the missing steps will be explained to the students and they will be asked to complete them. In the post-test phase, the 'Self-Confidence Scale' and the 'Student Satisfaction and Confidence in Learning Scale' will be administered to the students again. Two weeks after this process, the same scales will be filled in again for the final post-test.
Detailed description
Early diagnosis of breast cancer, one of the most common cancers worldwide, significantly enhances the success of treatment. It is crucial for midwifery students to learn breast self-examination and teach this technique to women. This study introduces an innovative approach to address the lack of practical experience among midwifery students. Breast examination mock-ups offer students the opportunity to practice in a safe and controlled environment, enabling them to apply their theoretical knowledge in practice. This contributes to enhancing students' clinical skills and improving their effectiveness in patient care. Moreover, the study aims to improve the quality of midwifery education by providing an effective solution to the challenges posed by limited resources and the increasing number of midwifery students.
By offering students the chance to practice in a secure environment, this study is expected to help midwifery students develop their skills and cope with the lack of clinical experience. The study aims to assess the use of breast examination models as a solution to this practical experience gap, providing students with an opportunity to refine their skills and enhance their clinical competence. The sample of this pre-test, post-test, follow-up randomised controlled study consisted of 64 midwifery students (experimental=32, and control=32). Data will be collected with Personal Information Form (PIF), Breast Examination Skills Assessment Form (BESAF), Self-Confidence Scale (SC) and Student Satisfaction and Confidence in Learning Scale (SCSLS). After obtaining the consent of the students in the experimental group, pre-test data will be obtained by filling out the 'Personal Information Form', 'Self-Confidence Scale' and 'Student Satisfaction and Confidence in Learning Scale'. Then, theoretical information will be given and the examination stages such as determining the area to be examined, manual examination of the area, examination method, nipple examination and detection of malignant formations in the breast will be explained practically in the breast examination model in the laboratory environment. Students will be taken in groups of 10, and after the application is explained, each student will perform the breast examination and evaluation individually. Approximately 15 minutes will be allocated for each student. Two weeks after the breast model application, the same students will be taken to the laboratory and asked to perform all the examination steps again. While the students are performing the examination steps, the researcher will mark the complete and incomplete applications on the 'Breast Examination Skill Evaluation Form' and the missing steps will be explained to the students and they will be asked to complete them. At the same time, 'Self-confidence Scale' and 'Student Satisfaction and Confidence in Learning Scale' will be filled out for the post-test. Then, two weeks later, the 'Self-Confidence Scale' and 'Student Satisfaction and Confidence in Learning Scale' will be filled out again for the final post-test. After obtaining the consent of the students in the control group, pre-test data will be collected by applying 'Personal Information Form', 'Self-Confidence Scale' and 'Student Satisfaction and Confidence in Learning Scale' to the students. Then, the students will be given theoretical information and a video will be shown to them, which includes examination stages such as determining the area to be examined, manual examination of the area, examination method, nipple examination and detection of malignant formations in the breast.
Two weeks later, the students will be taken to the laboratory environment and will be asked to perform the application steps in line with the theoretical course they have taken. While the students are performing the examination steps, the researcher will mark the complete and incomplete applications on the 'Breast Examination Skill Evaluation Form', then the missing steps will be explained to the students and they will be asked to complete them. In the post-test phase, the 'Self-Confidence Scale' and the 'Student Satisfaction and Confidence in Learning Scale' will be administered to the students again. Two weeks after this process, the same scales will be filled in again for the final post-test.
This study presents an innovative approach to supporting midwifery students in developing their clinical skills. The use of breast examination models enables students to better prepare for real clinical situations by applying theoretical knowledge. It is anticipated that students in the experimental group will exhibit higher levels of self-confidence and skill development compared to the control group. These findings could provide valuable data to promote the widespread adoption of model-assisted education in clinical training programs. Given the increasing number of students and the limitations of clinical facilities, model-assisted education emerges as a sustainable and effective solution to enhance the quality of midwifery programs. This method allows students to develop their skills without compromising patient safety and offers flexibility in the educational process. The study's results are expected to guide the structuring of educational programs in midwifery and other healthcare fields.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Model-assisted breast examination application | Experimental | Other: Model-assisted breast examination applicationAfter obtaining consent from the students in the experimental group, pre-test data will be collected by filling out the 'Personal Information Form,' 'Self-Confidence Scale,' and 'Student Satisfaction and Confidence in Learning Scale. After the theoretical information is given, the examination stages will be shown practically on the breast examination model in the laboratory environment. Students taken in groups of 10 will be examined and evaluated one by one after the lecture; 15 minutes will be allocated to each student. Two weeks later, the students will reapply all the examination steps in the laboratory, and the missing steps will be identified and completed by the researcher. In this process, 'Self-Confidence Scale' and 'Student Satisfaction and Confidence in Learning Scale' will be completed for the post-test. Two weeks later, the same scales will be applied again for the final post-test. |
| Control group | No intervention | –After obtaining consent from the control group students, pre-test data will be collected using the 'Personal Information Form,' 'Self-Confidence Scale,' and 'Student Satisfaction and Confidence in Learning Scale.' Students will then receive theoretical instruction and watch a video detailing examination stages, including identifying the area, manual examination, examination methods, nipple evaluation, and detecting malignant formations. Two weeks later, students will practice the steps in a laboratory setting based on the theoretical course. During the examination, the researcher will use the 'Breast Examination Skill Assessment Form' to note complete and incomplete steps, explain missing steps, and have students complete them. The 'Self-Confidence Scale' and 'Student Satisfaction and Confidence in Learning Scale' will be re-administered as a post-test. Two weeks later, the same scales will be used for a final post-test. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being a 2nd, 3rd or 4th year midwifery student at Karabük University Faculty of Health Sciences
- Being between the ages of 18-25
- Voluntarily agreeing to participate in the study
- Being a citizen of the Republic of Turkey
Key exclusion criteria (1 listed)
- Leave whenever you want without working.
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 |
|---|---|---|
| Model-assisted breast examination applicationDesigned for the development of self-examination skills, this model is in the shape of a female upper body with medium-sized breasts. Thanks to its ergonomic design, it can be worn easily and offers a comfortable use. Made of high quality, dermatologically tested and tactile silicone material. This model, which reflects all the details of the skin realistically, has a structure suitable for standing and lying examination. For educational use, there are 2 benign tumours, 4 malignant tumours and 2 typical anomalies. This model allows for practical explanation of all stages of breast examination such as determining the area to be examined, manual examination of the area, examination method, nipple examination and detection of malignant formations in the breast. | Other | Model-assisted breast examination application |
Primary outcome
Self-confidence Scale
Time frame: 2 mounth
Self-Confidence Scale is a 33-item Likert-type scale developed by Akın (2007) to assess the self-confidence level of individuals. The scale consists of two sub-dimensions: internal self-confidence and external self-confidence. The items are scored between 1 (Never) and 5 (Always). The total score ranges from 33 to 165, with higher scores indicating higher self-confidence. Self-confidence level is evaluated by dividing the total score by the number of items: Below 2.5 is considered low self-confidence, between 2.5-3.5 is considered medium self-confidence and above 3.5 is considered high self-confidence.
Student Satisfaction and Confidence in Learning Scale
Time frame: 2 mounth
The 'Student Satisfaction and Confidence in Learning Scale' developed to measure students' attitudes and beliefs about simulation was published by the National League for Nurses. The internal consistency coefficient of the scale, whose Turkish validity and reliability was performed by Karaçay and Kaya in 2017, was found to be 0.88. The scale has two sub-dimensions as 'satisfaction with learning' and 'self-confidence' and the total number of items is 13. The scale is answered in a five-point Likert scale. The minimum score obtained from the scale is 17 and the maximum score is 61.
Breast Examination Skill Assessment Form
Time frame: 3 mounth
The form prepared by the researchers to evaluate the participants' breast self-examination skills comprehensively includes the steps, techniques and points to be considered during breast examination. The form includes questions to evaluate the basic stages of breast examination such as observation, palpation (palpation), symmetry control, nipple examination, detection of masses or suspicious formations. In this way, the level of correct and complete application of the participants during breast examination is evaluated.
Personal Information Form
Time frame: 2 mounth
The form containing questions about the socio-demographic data of the participants was prepared by the researchers.
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 16 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Breast Self-Examination
Active, not recruiting
Health Belief Model-Based Breast Self-Examination Education in University Students
Breast Self-Examination
Active, not recruiting
Training On Self-Breast Examination Using Visual Breast Examination Materials For İlliterate Women.
Breast Cancer, Breast Self-Examination
RecruitingObservational study
Development of a Multidimensional Predictive Model of Dystocic Labor. Association of Physical Condition and Psychosocial Factors With the Birth Process and Breastfeeding Success.
Labor and Childbirth, Labor (Obstetrics)--Complications
Recruiting
AI-SUPPORTED FLIPPED LEARNING IN BREAST SELF-EXAMINATION TRAINING
Artifical Intelligence, Nursing Education
Not yet recruiting
A Single-Arm Interventional Trial of Pepper- Robot Delivered Cancer Education for Adults With Intellectual Disability
Cancer Awareness and Prevention Education, Breast Cancer Awareness
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Model-assisted breast examination application in people with Breast Self-Examination and Midwifery Students Education, run by Karabuk 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 1 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: opening soon, as of the sponsor's last update on 16 Jan 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 Merve AKINCI, Assistant Professor (+90 546 415 6469, merveakinci@karabuk.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-confidence Scale (time frame: 2 mounth). 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 16 Jan 2025.