NCT06777745

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2024

Completed
26 days until next milestone

Study Start

First participant enrolled

January 15, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

December 20, 2024

Last Update Submit

January 15, 2025

Conditions

Keywords

Midwifestudentbreast examinationmodel

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    3 mounth

  • Personal Information Form

    The form containing questions about the socio-demographic data of the participants was prepared by the researchers.

    2 mounth

Study Arms (2)

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.

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.

Interventions

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.

Model-assisted breast examination application

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Leave whenever you want without working.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabuk University

Karabük, Centre, 78600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Self-Examination

Condition Hierarchy (Ancestors)

Self-ExaminationHealth BehaviorBehavior

Central Study Contacts

Merve AKINCI, Assistant Professor

CONTACT

Merve Akıncı, Assistant Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The students were not informed about the groups they were in. Single blind was provided in the study by knowing which group they would be in by the researcher.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 20, 2024

First Posted

January 16, 2025

Study Start

January 15, 2025

Primary Completion

June 15, 2025

Study Completion

August 15, 2025

Last Updated

January 16, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations