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Clinical Trials/NCT07042737
NCT07042737Not yet recruitingNot Applicable

The Effect of Education Provided to Women in Menopause Through Animation on Breast Cancer Attitudes, Behaviors, and Screening Test Participation

Inonu University1 site in 1 country136 target enrollmentStarted: June 20, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
136
Locations
1
Primary Endpoint
menopause symptom scale

Study Overview

Brief Summary

The aim of this study was to determine the effect of education provided to women in menopause through animation on their attitudes toward breast cancer, behaviors, and screening test participation. The study will include a total of 136 women in the menopausal period, comprising 68 experimental group participants and 68 control group participants who have applied to the Orduyeri and Kırtepe Family Health Centers affiliated with the Bartın Public Health Institution. Women who agree to participate in the project, which will run from January to August 2025, will receive 40-45 minute training sessions in a suitable room at the ASM. The training sessions will be conducted in groups of 8-12 people. The training content will include information about the purpose, duration, and rules of the training. After providing information about the project, a pre-test will be administered. Through face-to-face interviews, researchers assigned to the project will show animated videos enriched with sound and images via an online program they have prepared. These videos will be 10-12 minutes long, and an interim test will be conducted. Three months after the pre-test, the women participating in the study will be contacted, and a final test will be administered in their own homes. Project data will be collected using the Personal Information Form, Champion Health Belief Scale, and Breast Cancer Awareness Scale. Descriptive statistics, independent sample t-tests, chi-square tests, and repeated measures analysis of variance (ANOVA) tests will be used in the statistical analysis of the project.

Detailed Description

Menopause is a stage of life in which women's reproductive functions cease due to a decline in ovarian activity and a corresponding decrease in the hormones produced by the ovaries. Seventy percent of women in menopause experience at least one symptom related to menopause. These symptoms can negatively affect women's daily lives, quality of life, interpersonal relationships, and sexual lives. Additionally, it increases women's risk of health issues such as breast cancer, cardiovascular disease, and obesity. Women's perceptions, attitudes, and behaviors toward menopause determine the methods they use to cope with these symptoms and health issues. Women spend one-third of their lives in menopause and use methods such as lifestyle changes, reflexology, massage, acupressure, and listening to music to cope with menopause symptoms and issues. Animation-based education is extremely important in terms of improving the quality of education and ensuring women's self-confidence and focus. There are studies in the literature that examine the effect of educational programs on breast cancer attitudes, behaviors, and screening test status in order to cope with menopausal symptoms and breast cancer. However, no studies have been found that evaluate educational applications delivered through animation, which is thought to increase the effectiveness of education. Based on this, this study was designed to determine the effect of education delivered through animation to women in menopause on breast cancer attitudes, behaviors, and screening test participation. The study will include a total of 136 women in the menopausal period, comprising 68 experimental group participants and 68 control group participants who have applied to the Orduyeri and Kırtepe Family Health Centers affiliated with the Bartın Public Health Institution. Women who agree to participate in the project, which will run from January to August 2025, will receive 40-45 minute training sessions in a suitable room at the ASM. The training sessions will be conducted in groups of 8-12 people. The training content will include information about the purpose, duration, and rules of the training. After providing information about the project, a pre-test will be administered. Through face-to-face interviews, researchers assigned to the project will show animated videos enriched with sound and images via an online program they have prepared. These videos will be 10-12 minutes long, and an interim test will be conducted. Three months after the pre-test, the women participating in the study will be contacted, and a final test will be administered in their own homes. Project data will be collected using the Personal Information Form, Champion Health Belief Scale, and Breast Cancer Awareness Scale. Descriptive statistics, independent sample t-tests, chi-square tests, and repeated measures analysis of variance (ANOVA) tests will be used in the statistical analysis of the project.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Investigator, Outcomes Assessor)

Masking Description

After randomization was performed by an independent researcher, the experimental group and control group were determined by lottery. In addition, the data will be analyzed by S.Ö., a researcher who did not collect the data, using masked data. The experimental and control groups will be assigned as A and B in the analysis program in such a way that S.Ö. will not know which group is which.

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Not having been diagnosed with breast cancer,
  • •not performing regular self-examinations (those who performed self-examinations at least once a month were excluded),
  • •not having had a mammogram (those who had a mammogram within the first six months after training were excluded),
  • •not having undergone a clinical breast examination (those who underwent a clinical breast examination within the first 6 months after the training were excluded),
  • •not breastfeeding or being pregnant, being literate, owning a smartphone,
  • •having internet access,
  • •not having uterine abnormalities,
  • •having ovaries,
  • •not having used sex hormones.

Exclusion Criteria

  • •never experiencing menopausal symptoms,
  • •undergoing surgical menopause,
  • •currently or previously using hormonal therapy,
  • •having a psychiatric disorder,
  • •having menstruated in the past year,
  • •incomplete forms,
  • •not fully participating in video-based education programs.

Arms & Interventions

experimental group: Breast cancer education group through animation

Experimental

The experimental group, determined by random selection, will include 68 women in menopause. These women will be asked to give their consent to participate in the study. After consent is obtained, a preliminary test will be conducted. Then, women in menopause will be educated on the symptoms and signs of breast cancer based on animation, self-breast examination, clinical breast examination, and mammography. The application will be conducted once a week. An interim test was conducted 14 days after the application, and a final test was conducted three months later.

Intervention: animation-based breast cancer education (Behavioral)

control group

Sham Comparator

No intervention was applied to the control group.

Intervention: Control group (placebo) (Other)

Outcomes

Primary Outcomes

menopause symptom scale

Time Frame: 3 month

The scale consists of a total of 11 items and 3 subscales. These 3 subscales are called the "Somatic Complaints subscale," "Psychological Complaints subscale," and "Urogenital Complaints subscale." The scale is a 5-point Likert scale. The score obtained from the scale ranges from 0 to 44 points. An increase in the total score obtained from the scale indicates an increase in the severity of menopausal complaints experienced.

Secondary Outcomes

  • Champion Health Belief Model Scale(3 month)
  • Breast Cancer Awareness Scale(3 month)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Simge Ozturk

principal ınvestigator

Inonu University

Study Sites (1)

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