The Effect of Value Clarification Based on Meleis's Transition Theory on Menopausal Symptoms, Depression, Anxiety, Stress, and Quality of Life in Perimenopausal Women

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое value clarification
  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.
• Другое control group
  The scales will be administered to the control group in parallel on the same dates.

Первичные конечные точки

• Change in menopausal symptoms measured by the Menopausal Symptom Assessment Scale [Срок оценки: 0-6 month]

Вторичные конечные точки (2)

• Change in menopause-specific quality of life measured by the Menopause-Specific Quality of Life Questionnaire (MENQOL) [Срок оценки: 0-6 month]
• 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. [Срок оценки: 0-6 month]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Corum Private Hospital — Çorum

Идентификаторы

NCT: NCT07584109 · OrduU-SBF-NKS-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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