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Breast Self-ExaminationNCT05960643

The Effect of Education Given According to the Health Belief Model on Breast Examination Skills

A study testing Training and application in breast modeling in people with Breast Self-Examination, run by Zahide Akeren at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The randomized controlled study to examine the effects of the educational interventions on BSE by revealing the breast self-examination (BSE) practices and breast health beliefs of female students studying at the university were completed with 101 students, 51 of whom were in the "experimental" and 50 "control"… Read more about this study

Who is it for?
Ages 17 to 30 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Self-Examination
What is being tested?
Training and application in breast modeling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
1 siteTurkey (Türkiye)
Study dates
21 Oct 2022to 2 Jan 2023
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 30 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • The criteria for inclusion in the study are that female students studying at a university in the Eastern Black Sea region of Turkey continue their education and have their contact addresses, have not received BSE training according to the Health Belief Model, have not been diagnosed with breast cancer, and agree to participate in the research.

Who cannot join

  • Students were excluded from the study if they did not want to continue the research at any stage of the study and were diagnosed with breast cancer.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Bayburt University

    Bayburt, 6900

Other trials in Turkey (Türkiye)

About this study

Official title: Health Belief Model on Breast Examination Skills

The randomized controlled study to examine the effects of the educational interventions on BSE by revealing the breast self-examination (BSE) practices and breast health beliefs of female students studying at the university were completed with 101 students, 51 of whom were in the "experimental" and 50 "control" groups. The data were collected between November and December 2022 at a university in the Eastern Black Sea region of Turkey, using the 'Personal Information Form', 'BSE Practice Skill Assessment Form' and the 'Health Belief Model Scale' as a pre-test. As an initiative, 'BSE training given according to the Health Belief Model', which includes 120 minutes of training, including theoretical and model-based BSE practice, was implemented. Then, 3 weeks later, the 'BSE Application Skill Evaluation Form' was applied as a post-test. Data were analyzed using Indepent Sample and Paired Sample t-test, Benferroni test, Pearson correlation analysis.

Read the detailed description

Materials and Methods Type of Research The research was carried out in a randomized controlled manner in order to reveal the breast self-examination (BSE) practices and breast health beliefs of female university students and to examine the effects of educational interventions on BSE.

Place and Time of Research The data of the research were collected at a university located in the Eastern Black Sea region of Turkey between December 2022 and January 2023.

Population and Sample of the Research The universe of the research consisted of female students studying at a university located in the Eastern Black Sea region of Turkey. The number of samples was calculated in the G*Power 3.1.9.7 program so that the error amount was α=0.05, the power of the test was 0.80 (80%) and the effect size was 0.60. As a result of the statistical analysis, it was found that a total of 90 students, 45 in the experimental group and 45 in the control group, should be included in the study. Considering that if the sample size increases, the standard error will decrease and the working power will increase, each group was increased by 22% (10 people) and a total of 110 students, 55 students for each group, were included in the study. The 'simple and stratified sampling' method was used as the randomization method. Simple and stratified randomization method was used in the planning of the research sample. Experimental and control groups within the scope of the study were determined by simple randomization method (coin-toss). In the first stage, the sample consisted of 148 students who agreed to participate in the study. In the second phase of the study, the sample consisted of 110 female students (55 experimental, 55 control) who were selected by simple and stratified randomization method and who had not received BSE training and breast cancer diagnosis according to the Health Belief Model.

Data Collection Tools The data were collected using the 'Personal Information Form' and the 'Health Belief Model Scale', and the 'BSE Practice Skills Evaluation Form' for the students in the experimental group. As an initiative, 'BSE training given according to the Health Belief Model' was carried out.

Personal Information Form This form was created by researchers by scanning the literature. There are 5 questions in the form: age, class, marital status, age at first menstruation, presence of breast cancer diagnosis in the family.

BSE Practice Skill Evaluation Form This form, which was created by the researchers by scanning the literature as a guide to the application made by the students on the wearable breast model, was evaluated over 100 points. The form included 7 skills: carefully reviewing the model, using three types of pressure, massage, hand position, performing three types of movement, examining each breast for five minutes, and detecting the nodule in the model. The high score was interpreted as having high skills.

Health Belief Model Scale (HBMS) This scale was first developed by Champion in 1984 based on the Health Belief Model. The scale has 8 dimensions: sensitivity, caring, health motivation, BSE barriers, benefits, self-efficacy, mammography benefits and barriers.

Breast Self Examination Training The training included 120 minutes of training on normal breast, breast cancer risk factors, symptoms, etiology, treatment, the role of healthy lifestyles in preventing breast cancer, screening and early diagnosis methods, BSE methods and BSE on a model.

Data Collection Method Experimental Group Data Collection Method This group consisted of 51 female students studying at a university located in the Eastern Black Sea region of Turkey. First of all, students were reached from their electronically registered contact information. On the day of the start of the training, the 'Personal Information Form' and the 'Health Belief Model Scale' as a pre-test were administered to the students by face-to-face interview method by the researchers. Afterwards, the students were given BSE training consisting of two 120-minute sessions. In the first session of the training, theoretical trainings on breast cancer and BSE were given for 30 minutes. In the second session, BSE application was shown on the wearable breast model and each student practiced on the model. The application was evaluated using the 'BSE Application Skill Evaluation Form'. At the end of the "Health Belief Model Scale" application, face-to-face and 3 weeks later, online applications were filled as a post-test.

Control Group Data Collection Method This group consisted of 50 female students studying at a university located in the Eastern Black Sea region of Turkey. First of all, students were reached from their electronically registered contact information. The 'Personal Information Form' and the 'Health Belief Model Scale' as a pre-test were filled in by online applications by the researchers. The individuals in this group did not receive any intervention. As a post-test, the Health Belief Model Scale was filled in online applications 3 weeks later as a post-test.

Being tested
Training and application in breast modeling, Control
Keywords
breast examination, Health Belief Model, skill
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.

  • Training and application in breast modelingOther

    Also called Experimental: Breast self-examination group

    BSE application skill evaluation form will be evaluated out of 100 points. The form includes 7 skills: carefully reviewing the model, using three types of pressure, massage, hand position, performing three types of movement, examining each breast for five minutes, and detecting the nodule in the model. A high score is interpreted as a high level of skills.

  • ControlOther

    No intervention will be made against people in this group.

Study groups in NCT05960643
Study groupRoleWhat they receive
Breast self-examination groupExperimentalThis group was planned to consist of 51 female students studying at the university. First of all, students will be contacted through their electronically registered contact information. In the pre-test, the researchers will apply the 'Personal Information Form' and the 'Health Belief Model Scale' to the students with the self-report method. Afterwards, students will be given BSE training consisting of two 120-minute sessions. In the first session of the training, theoretical trainings about breast cancer and BSE will be given for 30 minutes. In the second session, BSE application will be shown on the wearable breast model and each student will practice on the model. The practice skills of the participants will be evaluated by the researchers using the 'BSE Practice Skill Evaluation Form'. At the end of the 'Health Belief Model Scale' application, face-to-face and 3 weeks later, online applications will be filled as a post-test.
Receives: Other: Training and application in breast modeling
Control groupActive comparatorNo intervention will be made against people in this group.
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Breast Self Examination Practice Skill Assessment

    The form was created by the researchers by scanning the literature as a guide to the application made by the students on the wearable breast model. The form will be evaluated out of 100 points. The form includes 7 skills: carefully reviewing the model, using three types of pressure, massage, hand position, performing three types of movement, examining each breast for five minutes, and detecting the nodule in the model. A high score is interpreted as a high level of skills.

    Measured: Three weeks

Secondary outcomes (1)
  1. Health Belief Model Scale

    The scale does not have a grand total score. Each dimension uses its own total score. Sensitivity, caring, health motivation, BSE benefits, BSE barriers and BSE self-efficac were used. The scale is 5-point Likert type. A score closer to 5 means that sensitivity, caring, health motivation, BSE benefits, BSE barriers and BSE self-efficacy are perceived to be high.

    Measured: Three weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2023
  2. Study start21 Oct 2022
  3. Primary completion12 Dec 2022
  4. Study completion2 Jan 2023

Resources

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
The sample size of the study was calculated in the G\*Power 3.1.9.7 program such that the error amount was α=0.05, the power of the test was 0.80 (80%) and the effect size was 0.60. As a result of the statistical analysis, it was found that a total of 90 students, 45 in the experimental group and 45 in the control group, should be included in the study. Considering that if the sample size increases, the standard error will decrease and the working power will increase, each group was increased by 22% (10 people) and it was planned to include 110 students in the study, 55 students for each group. In the first stage, the sample consisted of 148 students who agreed to participate in the study. In the second phase of the study, the sample was planned to consist of 110 female students selected by simple and stratified randomization method (55 experimental, 55 control).
Masking
Single blind
Who is masked
Participant
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05960643
Sponsor's protocol ID
BREAST EXAMINATION SKILLS
Other IDs
Bayburt University
Status last verified
Jul 2023
First submitted
15 Jun 2023
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Training and application in breast modeling in people with Breast Self-Examination, run by Zahide Akeren 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 1 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: finished, as of the sponsor's last update on 27 Jul 2023. 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?

Breast Self Examination Practice Skill Assessment (time frame: Three weeks). 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 27 Jul 2023.

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