- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
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
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Altindağ
-
Ankara, Altindağ, Turquía (Türkiye), 06250
- Ankara University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
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
¿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
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Ankara University Thesis
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
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.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .