- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07584109
The Effect of Value Clarification Based on Meleis's Transition Theory on Menopausal Symptoms, Depression, Anxiety, Stress, and Quality of Life in Perimenopausal Women
Menopause is a life stage influenced not only by hormonal factors but also by psychological, social, and cultural factors. Symptoms such as hot flashes, sleep problems, and mood changes may occur, and their severity depends on how a woman perceives and copes with this period.
The study aims to examine the effects of the "Value Clarification" method based on Meleis Transition Theory on menopausal symptoms, depression, anxiety, stress, and quality of life in women during menopause.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Menopause is a unique life event in a woman's life, influenced not only by physiological or hormonal factors, but also by cultural, psychological, and social factors. These changes that occur in a woman's life during menopause affect her quality of life, life satisfaction, and happiness.
Menopause is associated with vasomotor symptoms such as hot flashes and night sweats, musculoskeletal problems, sleep disturbances, urogenital changes, dyspareunia, sexual dysfunction, and mood swings. The number, severity, and impact of these symptoms on a woman's life depend on how she copes with this special period. A woman's perspective on the process is influenced by many factors. Being prepared for this period, not viewing it as the end of womanhood, and being aware of her own worth will reduce the degree to which she is negatively affected by menopause. Studies show that women who develop a positive attitude towards menopause experience milder symptoms. It can be said that there are limitations in the current system of care for the menopausal process in terms of changing the lack of information and negative perspectives on menopause.
In this context, this study aimed to examine the effects of Value Clarification, based on Meleis Transition Theory, on perimenopausal women's menopausal symptoms, depression, anxiety, stress levels, and menopause-specific quality of life.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Neslihan KAZAK SALTAN, PhD
- Número de teléfono: +905051059426
- Correo electrónico: neslihankazak0369@hotmail.com
Ubicaciones de estudio
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Centre
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Çorum, Centre, Turquía (Türkiye), 19100
- Corum Private Hospital
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Contacto:
- Neslihan KAZAK SALTAN, PhD
- Número de teléfono: 05051059426
- Correo electrónico: neslihankazak0369@hotmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Women who agree to participate in the study,
- Have at least a primary school education,
- Understand, read, and write Turkish,
- Have no communication barriers,
- Are between 45-55 years of age,
- Have started experiencing menstrual cycle irregularities or have not menstruated,
- Have experienced at least one menopausal symptom in the last 6 months (hot flashes, irritability, sleep problems, urogenital complaints, etc.),
- Are in the perimenopausal period according to the Straw Classification of Reproductive Aging in Women criteria,
- Women who have entered menopause naturally will be included in the study.
Exclusion Criteria:
- Women who:
- Use any complementary or alternative treatment methods (such as Reiki, phytoestrogens, acupressure),
- Use hypnotic or sedative medications,
- Have a diagnosed psychiatric illness,
- Have a gynecological problem causing menstrual irregularities,
- Have entered menopause as a result of any surgical operation such as a hysterectomy,
- Are receiving hormone replacement therapy will be excluded 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: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Intervention group: Value clarification group
The value clarification exercise will be administered to the intervention group once a month for three months.
The results at the third and sixth months will be evaluated using scales.
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The intervention group will be given written clarification of values.
After the pre-test, clarification will be applied once a month for 3 months, and the scales will be completed in the 3rd and 6th months.
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Comparador activo: Control group: No intervention will be applied.
The control group will not receive the scales, but will be administered in parallel as a pre-test, at 3 months, and at 6 months.
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The scales will be administered to the control group in parallel on the same dates.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in menopausal symptoms measured by the Menopausal Symptom Assessment Scale
Periodo de tiempo: 0-6 month
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The value explanation method based on transition theory improves menopausal symptoms in women when applied to perimenopausal women.
The Menopausal Symptom Assessment Scale was developed to measure the severity of menopausal symptoms.
The scale, adapted into Turkish, consists of 11 items and 3 sub-dimensions.
These sub-dimensions are somatic complaints (items 1, 2, 3, and 11), psychological complaints (items 4, 5, 6, and 7), and urogenital complaints (items 8, 9, and 10).
The Likert-type scale, which includes menopausal complaints, uses the options: 0: None, 1: Mild, 2: Moderate, 3: Severe, and 4: Very severe.
The total score is calculated from the scores obtained from each item.
The lowest possible score is "0," and the highest is "44."
An increase in the total score indicates an increase in the severity of complaints and a negative impact on quality of life.
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0-6 month
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in menopause-specific quality of life measured by the Menopause-Specific Quality of Life Questionnaire (MENQOL)
Periodo de tiempo: 0-6 month
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Value clarification based on transition theory given to perimenopausal women improves their menopause-specific quality of life. The scale, originally called the Menopause-Specific Quality of Life Questionnaire, was developed to assess the extent to which menopausal symptoms affect women's quality of life. The Turkish adaptation of is a Likert-type scale containing 29 questions. The scale consists of four sub-dimensions: Vasomotor (questions 1-3), Psychosocial (questions 4-10), Physical (questions 11-26), and Sexual (questions 27-29). Participants rate each symptom on a scale of 0-6, indicating its presence or absence. "NO" indicates the absence of the symptom, "PRESENT" or a score of 0 indicates the presence of the symptom, and a score of 1-6 indicates the severity and increasing degree of the existing problem. |
0-6 month
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Changes in depression, anxiety, and stress levels that may be caused by mood swings during menopause were measured using the Depression Anxiety Stress Scale-21.
Periodo de tiempo: 0-6 month
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Depression, anxiety, and stress levels will be assessed using the Depression Anxiety Stress Scale-21, a validated self-report questionnaire consisting of 21 items divided into three subscales: depression, anxiety, and stress (7 items each). Each item is scored on a 4-point Likert scale (0-3), where higher scores indicate greater symptom severity. Subscale scores are calculated by summing the relevant items, with possible scores ranging from 0 to 21 for each subscale. Severity thresholds are defined as follows: Depression: ≥14 indicates very severe depression Anxiety: ≥10 indicates very severe anxiety Stress: ≥17 indicates very severe stress |
0-6 month
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Nülüfer ERBİL, Prof. Dr., Ordu university
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- OrduU-SBF-NKS-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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