Clinical trial NCT05960643: The Effect of Education Given According to the Health Belief Model on Breast Examination Skills
Official title: Health Belief Model on Breast Examination Skills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Self-Examination
Keywords: breast examination
Health Belief Model
skill
Lead sponsor: Bayburt University
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 101
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: SUPPORTIVE_CARE

Brief 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" 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Breast Self Examination Practice Skill Assessment
timeFrame: Three weeks
Secondary outcomes:
measure: Health Belief Model Scale
timeFrame: Three weeks
Other outcomes:
Locations:
city: Bayburt
country: Turkey
facility: Bayburt University
Study officials:
affiliation: Bayburt University
name: Bayburt University
role: STUDY_CHAIR
References: