- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07771946
Audio-Described Menopause Education Program in Visually Impaired Women
The Effect of Education Provided Through Audio Description Method on Menopause Knowledge and Menopausal Symptoms in Visually Impaired Women: Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Altindağ
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Ankara, Altindağ, Turkey (Türkiye), 06250
- Ankara University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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).
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Audio description-based menopause education program
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.
|
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.
|
|
No Intervention: Standard of care
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Measured at three time points: baseline (pre-test), immediately after the intervention (T1), and 1 month post-intervention (T2).
|
|
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.
|
Measured at three time points: baseline (pre-test), immediately after the intervention (T1), and 1 month post-intervention (T2).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ankara University Thesis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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