MenopauseNCT07771946
Audio-Described Menopause Education Program in Visually Impaired Women
A study testing Audio-Described Menopause Education Program in people with Menopause and Visual Impairment and Blindness (Excl Colour Blindness), run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial was conducted to evaluate the effect of an audio-described menopause education program on menopause knowledge and menopausal symptoms in women with visual impairment. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Menopause, Visual Impairment and Blindness (Excl Colour Blindness), Menopausal Symptoms
- What is being tested?
- Audio-Described Menopause Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2025to 15 Jul 2025
- 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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Being a member of the Ankara Branch of the Altı Nokta Blind Association,
- Being a woman with visual impairment (congenital or acquired),
- Being female,
- Being between 40 and 60 years of age,
- Being able to speak Turkish,
- Having no additional communication problems other than visual impairment,
- Having experienced at least 12 months of amenorrhea (STRAW+1 criteria).
Who cannot join
- Refusal to participate in the study,
- Previous participation in a structured menopause-related education program,
- Use of pharmacological treatment for the management of menopausal symptoms,
- Use of non-pharmacological methods for menopausal symptom management (e.g., yoga, aromatherapy, phytotherapy, etc.),
- Surgical menopause,
- Having additional disabilities other than visual impairment (hearing, intellectual, or physical disabilities).
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- Withdrawal / Discontinuation Criteria
- Initiation of any pharmacological or non-pharmacological intervention aimed at reducing menopausal symptoms during the study period,
- Non-adherence to the study protocol,
- Voluntary withdrawal from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Education Provided Through Audio Description Method on Menopause Knowledge and Menopausal Symptoms in Visually Impaired Women: Randomized Controlled Trial
This randomized controlled trial was conducted to evaluate the effect of an audio-described menopause education program on menopause knowledge and menopausal symptoms in women with visual impairment. A total of 46 women who were members of the Ankara Branch of the Altı Nokta Blind Association were randomly assigned to either an intervention group (n=23) or a control group (n=23). The intervention group received an accessible menopause education program, while the control group did not receive the intervention during the study period. Outcomes included menopause knowledge and menopausal symptom severity, assessed using standardized measurement tools.
Read the detailed description
This study was designed as a randomized controlled trial in accordance with CONSORT guidelines. It aimed to determine the effectiveness of an audio-described menopause symptom and awareness education program for women with visual impairment on menopause knowledge and menopausal symptoms.
The study sample consisted of 46 women who were members of the Ankara Branch of the Altı Nokta Blind Association. Participants were randomly allocated in a 1:1 ratio to either the intervention group (n=23) or the control group (n=23).
Data were collected using a demographic information form, the Menopause Knowledge Scale, and the Menopause Rating Scale. The intervention group received an audio-described educational program designed to improve accessibility for women with visual impairment, while the control group did not receive the intervention during the study period.
Statistical analyses included descriptive statistics, Fisher-Freeman-Halton Exact test, Pearson chi-square test, Cronbach's alpha reliability analysis, assessment of skewness and kurtosis for normality, Pearson correlation analysis, independent samples t-test, and analysis of covariance (ANCOVA). Statistical significance was set at p < 0.05.
- Conditions
- Menopause, Visual Impairment and Blindness (Excl Colour Blindness), Menopausal Symptoms, Women's Health Education
- Being tested
- Audio-Described Menopause Education Program
- Keywords
- Menopause, Visually impaired women, Audio-described education, Menopause education program, Menopause knowledge, Menopausal symptoms, Randomized controlled trial
- Medical subject headings
- Vision Disorders, Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audio-Described Menopause Education ProgramBehavioural
This intervention consisted of a structured audio-described menopause education program developed for women with visual impairment. The program provided accessible information about menopause, menopausal symptoms, and symptom management strategies to improve knowledge and awareness.
| Study group | Role | What they receive |
|---|---|---|
| Audio description-based menopause education program | Experimental | Participants in this arm received an audio-described menopause education program designed for women with visual impairment. The intervention aimed to improve menopause knowledge and reduce menopausal symptom-related difficulties. The educational content was delivered in an accessible format tailored to participants' needs. Outcomes were assessed using standardized measurement tools. Receives: Behavioral: Audio-Described Menopause Education Program |
| Standard of care | No intervention | Participants in this arm did not receive the audio-described menopause education program during the study period. They continued with their usual daily life without any structured educational intervention related to menopause. Outcomes were assessed at the same time points using standardized measurement tools. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopause Knowledge
To assess changes in menopause knowledge following the audio-described menopause education program. The total score of the "Menopause Knowledge Scale" ranges from 14 to 70, with higher scores indicating a higher level of overall knowledge about menopause. Similarly, higher scores on the General Menopause Knowledge subscale (5-25) and the Knowledge of Menopausal Symptoms and Management subscale (9-45) indicate greater knowledge in the respective domains.
Measured: Measured at three time points: baseline (pre-test), immediately after the intervention (T1), and 1 month post-intervention (T2).
Menopausal Symptom Severity
To evaluate changes in menopausal symptom severity following the audio-described menopause education program. The Menopause Rating Scale was used to assess the severity of menopausal symptoms.The total score of the scale ranges from 0 to 44. Higher total scores indicate greater severity of menopausal symptoms and a more negative impact on quality of life.
Measured: Measured at three time points: baseline (pre-test), immediately after the intervention (T1), and 1 month post-intervention (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start15 Feb 2025
- Primary completion15 Jul 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by Ankara 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
- This study was conducted as a parallel-group randomized controlled trial. Participants were randomly assigned to either an intervention group or a control group in a 1:1 allocation ratio. The study followed CONSORT guidelines for randomized trials.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlknur Münevver Gönenç, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771946
- Sponsor's protocol ID
- Ankara University Thesis
- Status last verified
- Aug 2026
- First submitted
- 3 Jul 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data, including baseline characteristics and outcome measures, will be shared. No identifiable personal data will be included.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Provided Through Audio Description Method on Menopause Knowledge and Menopausal Symptoms in Visually Impaired Women: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07771946
- Acronym / sponsor ID
- Ankara University Thesis
- Conditions
- Menopause, Visual Impairment and Blindness (Excl Colour Blindness), Menopausal Symptoms, Women's Health Education
- Keywords
- Menopause, Visually impaired women, Audio-described education, Menopause education program, Menopause knowledge, Menopausal symptoms, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 19 Aug 2026 (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.
This randomized controlled trial was conducted to evaluate the effect of an audio-described menopause education program on menopause knowledge and menopausal symptoms in women with visual impairment. A total of 46 women who were members of the Ankara Branch of the Altı Nokta Blind Association were randomly assigned to either an intervention group (n=23) or a control group (n=23). The intervention group received an accessible menopause education program, while the control group did not receive the intervention during the study period. Outcomes included menopause knowledge and menopausal symptom severity, assessed using standardized measurement tools.
Detailed description
This study was designed as a randomized controlled trial in accordance with CONSORT guidelines. It aimed to determine the effectiveness of an audio-described menopause symptom and awareness education program for women with visual impairment on menopause knowledge and menopausal symptoms.
The study sample consisted of 46 women who were members of the Ankara Branch of the Altı Nokta Blind Association. Participants were randomly allocated in a 1:1 ratio to either the intervention group (n=23) or the control group (n=23).
Data were collected using a demographic information form, the Menopause Knowledge Scale, and the Menopause Rating Scale. The intervention group received an audio-described educational program designed to improve accessibility for women with visual impairment, while the control group did not receive the intervention during the study period.
Statistical analyses included descriptive statistics, Fisher-Freeman-Halton Exact test, Pearson chi-square test, Cronbach's alpha reliability analysis, assessment of skewness and kurtosis for normality, Pearson correlation analysis, independent samples t-test, and analysis of covariance (ANCOVA). Statistical significance was set at p < 0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study was conducted as a parallel-group randomized controlled trial. Participants were randomly assigned to either an intervention group or a control group in a 1:1 allocation ratio. The study followed CONSORT guidelines for randomized trials.
| Arm | Type | Receives |
|---|---|---|
| Audio description-based menopause education program | Experimental | Behavioral: Audio-Described Menopause Education ProgramParticipants in this arm received an audio-described menopause education program designed for women with visual impairment. The intervention aimed to improve menopause knowledge and reduce menopausal symptom-related difficulties. The educational content was delivered in an accessible format tailored to participants' needs. Outcomes were assessed using standardized measurement tools. |
| Standard of care | No intervention | –Participants in this arm did not receive the audio-described menopause education program during the study period. They continued with their usual daily life without any structured educational intervention related to menopause. Outcomes were assessed at the same time points using standardized measurement tools. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Being a member of the Ankara Branch of the Altı Nokta Blind Association,
- Being a woman with visual impairment (congenital or acquired),
- Being female,
- Being between 40 and 60 years of age,
- Being able to speak Turkish,
Key exclusion criteria (10 listed)
- Refusal to participate in the study,
- Previous participation in a structured menopause-related education program,
- Use of pharmacological treatment for the management of menopausal symptoms,
- Use of non-pharmacological methods for menopausal symptom management (e.g., yoga, aromatherapy, phytotherapy, etc.),
- Surgical menopause,
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 |
|---|---|---|
| Audio-Described Menopause Education ProgramThis intervention consisted of a structured audio-described menopause education program developed for women with visual impairment. The program provided accessible information about menopause, menopausal symptoms, and symptom management strategies to improve knowledge and awareness. | Behavioural | Audio description-based menopause education program |
Primary outcome
Menopause Knowledge
Time frame: Measured at three time points: baseline (pre-test), immediately after the intervention (T1), and 1 month post-intervention (T2).
To assess changes in menopause knowledge following the audio-described menopause education program. The total score of the "Menopause Knowledge Scale" ranges from 14 to 70, with higher scores indicating a higher level of overall knowledge about menopause. Similarly, higher scores on the General Menopause Knowledge subscale (5-25) and the Knowledge of Menopausal Symptoms and Management subscale (9-45) indicate greater knowledge in the respective domains.
Menopausal Symptom Severity
Time frame: Measured at three time points: baseline (pre-test), immediately after the intervention (T1), and 1 month post-intervention (T2).
To evaluate changes in menopausal symptom severity following the audio-described menopause education program. The Menopause Rating Scale was used to assess the severity of menopausal symptoms.The total score of the scale ranges from 0 to 44. Higher total scores indicate greater severity of menopausal symptoms and a more negative impact on quality of life.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified participant data, including baseline characteristics and outcome measures, will be shared. No identifiable personal data will be included.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audio-Described Menopause Education Program in people with Menopause and Visual Impairment and Blindness (Excl Colour Blindness), run by Ankara 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 7 inclusion and 10 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 19 Aug 2026. 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?
Menopause Knowledge (time frame: Measured at three time points: baseline (pre-test), immediately after the intervention (T1), and 1 month post-intervention (T2).). The study lists 2 primary outcomes in all. 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 19 Aug 2026.