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Audio-Described Menopause Education Program in Visually Impaired Women

17 de agosto de 2026 actualizado por: İlknur Münevver Gönenç, Ankara University

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

46

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Altindağ
      • Ankara, Altindağ, Turquía (Türkiye), 06250
        • Ankara University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Sin intervención: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Menopause Knowledge
Periodo de tiempo: 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
Periodo de tiempo: 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).

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

15 de febrero de 2025

Finalización primaria (Actual)

15 de julio de 2025

Finalización del estudio (Actual)

15 de julio de 2025

Fechas de registro del estudio

Enviado por primera vez

3 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

17 de agosto de 2026

Publicado por primera vez (Actual)

19 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

19 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

De-identified participant data, including baseline characteristics and outcome measures, will be shared. No identifiable personal data will be included.

Marco de tiempo para compartir IPD

De-identified individual participant data will be available beginning 6 months after publication of the study results and will remain available for 5 years.

Criterios de acceso compartido de IPD

Access to individual participant data and supporting documents will be granted to qualified researchers who submit a methodologically sound research proposal. Requests must be approved by the principal investigator or study sponsor. Data will be provided for non-commercial academic research purposes only. All data will be de-identified, and no personally identifiable information will be shared. Data will be shared via secure electronic transfer upon approval.

Tipo de información de apoyo para compartir IPD

  • SAVIA

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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