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Набор скоро начнётся NCT07149285

Effect of Mandala Practice on Menopausal Symptoms and Quality of Life

Без фазы С лечением Menopause Symptom Management Quality of Life Menopausal Symptoms

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Mandala coloring.
Кому может быть актуально
Состояния в реестре: Menopause Symptom Management, Quality of Life, Menopausal Symptoms. Базовые параметры: 40 лет — 55 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Обзор

Menopause is a natural cycle of life that mostly develops due to changes in the endocrine glands of the female body during middle age, and the menstrual cycle is permanently interrupted as a result of the ovaries losing their activity. Many symptoms are observed in women during menopause, and these symptoms cause women to experience many physiological, mental, social and sexual problems in the short or long term and to deteriorate their quality of life. In reducing the menopause symptoms experienced by women, hormone replacement therapy, traditional methods, mental or physical applications; aromatherapy, hypnosis, Biofeedback and relaxation techniques are used. The aim of these applications; is to relax women, reduce menopausal symptoms and increase their quality of life. Mandala, which has been widely used in the field of therapy in the past and today, is seen as a meditation tool in art therapy and is defined as a complementary, safe and accessible activity that supports mental health. It has been determined that how the mandala method, which is used in many areas in the literature, affects the symptoms and quality of life of women in the menopausal period has not been examined. For this reason, it is thought that this study will make a significant contribution to the literature.

Подробное описание

This study was designed as a randomized controlled experimental trial to examine the effects of mandala practice on menopausal symptoms and quality of life. The study will be conducted with 78 women (experimental = 39, control = 39) diagnosed with menopause at the Private Palmiye Hospital Gynecology and Obstetrics Outpatient Clinics. Participants will be randomly assigned to groups via random.org. Women in the experimental group will practice mandala coloring for 20-30 minutes daily for 15 days, while the control group will only be administered the scales and will be advised to practice mandala practice at the end of the study due to ethical principles. Data will be collected using a Personal Information Form, the Menopause Symptoms Assessment Scale, the Menopause-Specific Quality of Life Scale, and the Mandala Practice Follow-up Form. Data will be analyzed using frequency, descriptive statistics, the Shapiro-Wilks normality test, the independent samples t-test, one-way analysis of variance, and the Pearson correlation test in SPSS 24.0. It is anticipated that the findings of the study will make a significant contribution to the literature by revealing the effect of mandala practice in reducing symptoms and improving quality of life in menopausal women.

Вмешательства

  • Другое Mandala coloring
    Intervention Group: The content of the study and the mandala application will be explained to women diagnosed with menopause, and after obtaining consent, a personal information form and scales regarding menopause symptoms and quality of life will be applied. Participants will be given a sample and blank mandala, 12 colored crayons and a follow-up form. The mandala application will be done for 20-30 minutes every day for 15 days, and will be monitored by phone every other day. At the end of the

Первичные конечные точки

  • Menopausal Symptoms Assessment Scale (MSAS) total score [Срок оценки: Pre-intervention (day 0) and post-intervention (day 15)]
Вторичные конечные точки (1)
  • Menopause-Specific Quality of Life Scale (MSQL) total and sub-dimension scores [Срок оценки: Pre-intervention (day 0) and post-intervention (day 15)]

Критерии участия

Критерии включения

  • The study included women who met the following conditions:
  • Absence of cognitive, hearing, or speech impairments that could interfere with effective communication,
  • No physical, psychological, or visual limitations that could hinder participation in mandala coloring activities,
  • Literacy in Turkish, including the ability to read, comprehend, and write,
  • A confirmed medical diagnosis of menopause,
  • Not undergoing any form of psychotherapy or alternative treatment throughout the study period,
  • Voluntary participation with signed informed consent.

Критерии исключения

  • Participants were excluded from the study if they:
  • Provided incomplete or inaccurate responses in the data collection forms,
  • Were receiving hormone therapy to manage menopausal symptoms,
  • Had a neurological disorder that could impair concentration or communication during the mandala activity,
  • Had known allergies to paints or similar substances.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Private Palmiye Hospital, Gynecology and Obstetrics Clinic — Hatay

Идентификаторы

NCT: NCT07149285 · Protocol No:2025/523

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗