Menopausal WomenMenopauseNCT07042737
The Effect of Animation-Based Education on Menopausal Women's Attitudes, Behaviors, and Screening Test Participation Regarding Breast Cancer
A study testing animation-based breast cancer education in people with Menopausal Women and Education Nursing, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopausal Women, Education Nursing, Breast Cancer Females
- What is being tested?
- animation-based breast cancer education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2025to 20 Oct 2026
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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,
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- not having uterine abnormalities,
- having ovaries,
- not having used sex hormones.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Education Provided to Women in Menopause Through Animation on Breast Cancer Attitudes, Behaviors, and Screening Test Participation
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.
Read the 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.
- Conditions
- Menopausal Women, Education Nursing, Breast Cancer Females, Motivation, Screening Strategy
- Being tested
- animation-based breast cancer education, Control group (placebo)
- Keywords
- education through animation, menopause, breast cancer, screening test, motivation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
animation-based breast cancer educationBehavioural
The animation-based humorous application consists of four videos, each lasting 40-45 minutes, which separately explain the signs and symptoms of breast cancer, self-breast examination, clinical breast examination, and mammography through animation.
Control group (placebo)Other
No intervention will be applied to the control group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: animation-based breast cancer education |
| control group | Sham comparator | No intervention was applied to the control group. Receives: Other: Control group (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
menopause symptom scale
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.
Measured: 3 month
Secondary outcomes (2)
Champion Health Belief Model Scale
The scale has eight subscales and consists of 58 items. These are: importance/seriousness, sensitivity, health motivation, benefits and barriers to self-breast examination, self-efficacy, and benefits and barriers to mammography. Scale items are scored on a scale of 1 to 5. The lowest score for all dimensions of the scale is the sum of the lowest scores of the subgroup, and the highest score is the sum of the highest scores of the subgroup. It has been noted that as the score obtained from the scale increases, the subdimensions also increase.
Measured: 3 month
Breast Cancer Awareness Scale
The scale consists of a total of 13 items, including symptoms (11 items), breast examination frequency (1 item), and age of breast cancer (1 item), to determine the breast cancer awareness scale. There is no cut-off point for the scale. When 5 symptoms are reported, 1 point is awarded; when a woman aged 70 is indicated, 1 point is awarded; and when a monthly breast examination is reported, 1 point is awarded. Incorrect answers receive 0 points. Scoring ranges from 0 to 3. It has been determined that as the score from the scale increases, breast cancer awareness also increases.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start20 Jun 2025 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal WomenStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Model description
- Participants identified by researchers prior to the start of the study were divided into experimental and control groups using a randomization method. Women in the experimental group will receive 40-45 minute training sessions once a week for one week on specified days and times. The training sessions will be conducted in groups of 8-12 people. The content of the training sessions will include information about the purpose, duration, and rules of the training. After the information is provided, a pre-test will be administered. Using the face-to-face interview method, researchers involved in the study will show animated videos enriched with sound and images through an online program they have prepared, lasting 10-12 minutes. A mid-test will be conducted 14 days after the pre-test. 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simge Ozturk, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042737
- Sponsor's protocol ID
- Inonu7
- Acronym
- Menopause
- Status last verified
- Jun 2025
- First submitted
- 20 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Provided to Women in Menopause Through Animation on Breast Cancer Attitudes, Behaviors, and Screening Test Participation
- ClinicalTrials.gov ID
- NCT07042737
- Acronym / sponsor ID
- Menopause / Inonu7
- Conditions
- Menopausal Women, Education Nursing, Breast Cancer Females, Motivation, Screening Strategy
- Keywords
- education through animation, menopause, breast cancer, screening test, motivation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 20 Jun 2025 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 29 Jun 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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants identified by researchers prior to the start of the study were divided into experimental and control groups using a randomization method. Women in the experimental group will receive 40-45 minute training sessions once a week for one week on specified days and times. The training sessions will be conducted in groups of 8-12 people. The content of the training sessions will include information about the purpose, duration, and rules of the training. After the information is provided, a pre-test will be administered. Using the face-to-face interview method, researchers involved in the study will show animated videos enriched with sound and images through an online program they have prepared, lasting 10-12 minutes. A mid-test will be conducted 14 days after the pre-test. 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.
| Arm | Type | Receives |
|---|---|---|
| experimental group: Breast cancer education group through animation | Experimental | Behavioral: animation-based breast cancer educationThe 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. |
| control group | Sham comparator | Other: Control group (placebo)No intervention was applied to the control group. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (7 listed)
- never experiencing menopausal symptoms,
- undergoing surgical menopause,
- currently or previously using hormonal therapy,
- having a psychiatric disorder,
- having menstruated in the past year,
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 |
|---|---|---|
| animation-based breast cancer educationThe animation-based humorous application consists of four videos, each lasting 40-45 minutes, which separately explain the signs and symptoms of breast cancer, self-breast examination, clinical breast examination, and mammography through animation. | Behavioural | experimental group: Breast cancer education group through animation |
| Control group (placebo)No intervention will be applied to the control group. | Other | control group |
Primary outcome
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.
2 secondary outcomes
Champion Health Belief Model Scale
Time frame: 3 month
Breast Cancer Awareness Scale
Time frame: 3 month
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 29 Jun 2025.
- Individual participant dataSharing planned: No
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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 animation-based breast cancer education in people with Menopausal Women and Education Nursing, run by Inonu 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 9 inclusion and 7 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 29 Jun 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. Some participants in this study may receive a placebo. 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 Simge Öztürk, Ph.D (+905398751788, simgeozturk2123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
menopause symptom scale (time frame: 3 month). 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 29 Jun 2025.