Psychosocial Effects of Mindfulness-Based Exercise in Postmenopausal Women

Официальное название

The Effects of Mindfulness-Based Exercise on Anxiety, Depression, and Sleep Quality in Postmenopausal Women

Обзор

Menopause is a natural biological process characterized by the permanent cessation of the menstrual cycle in women. Hormonal changes associated with menopause commonly lead to mood swings, anxiety, depression, stress, and decreased sleep quality in women. While the current literature indicates that mindfulness-based interventions offer potential benefits in alleviating psychological and physical symptoms in postmenopausal women, the limited number of studies in the literature and methodological differences suggest a need for more randomized controlled trials in this area. The aim of this study is to examine the effect of mindfulness-based exercises on psychosomatic complaints such as anxiety, depression, and sleep quality in postmenopausal women. Designed as a randomized controlled experimental study, it was planned to include at least 20 women in the early postmenopausal period residing in Istanbul and Izmir between March and June 2026. The women included in the study will be randomized into Group 1 (n=10), which will perform mindfulness-based exercises, and Group 2 (n=10), which will receive no intervention as usual. The STAI I-II Form State and Trait Anxiety Scale and Beck Anxiety Inventory will be used to assess state and anxiety level, the Beck Depression Scale for depression level, and the Pittsburgh Sleep Quality Scale for sleep quality. Continuous variables will be presented as mean ± standard deviation, and qualitative variables as number and percentage (%). If parametric test assumptions are met, the Independent Samples t-test will be used to compare independent groups, and the Paired Samples t-test will be used to compare dependent groups. If parametric test assumptions are not met, the Mann-Whitney U test will be used to compare independent groups, and the Wilcoxon test will be used to compare dependent groups. Statistical significance will be set at p≤0.05. This study is expected to contribute to the literature by providing evidence-based data on the effectiveness of mindfulness-based exercises on common psychological symptoms in the postmenopausal period.

Подробное описание

Menopause is a natural biological process characterized by the permanent cessation of the menstrual cycle, beginning with the absence of menstruation for 12 consecutive months following a woman's last menstrual bleeding. The basic physiological mechanism of menopause is related to the increase in follicle-stimulating hormone (FSH) levels and the decrease in estrogen levels. This period brings about many biological, physical, and psychological changes, along with changes in reproductive functions. With the decrease in estrogen levels, reproductive functions are lost, leading to various changes in women. The decrease in estradiol and inhibin levels and the increase in FSH and luteinizing hormone levels during the menopausal transition period lead to several physical and psychological effects in women, primarily including impaired sleep quality. Hormonal changes associated with menopause most frequently lead to mood swings, anxiety, depression, stress, and decreased quality of life in women. It is also reported that problems such as hot flashes, sweating, especially in the facial area, sexual dysfunction, increased hair growth, skeletal disorders, osteoporosis, appetite changes and weight problems, difficulty concentrating, and vaginal itching are commonly observed. Problems occurring in this new phase of an individual's life can negatively affect the daily lives and functions of postmenopausal women, creating a need for effective coping with the encountered problems.

Mindfulness refers to an individual's ability to focus on their sensations, thoughts, physical condition, state of consciousness, and environment with non-judgmental awareness. This approach is characterized by fundamental qualities such as openness, curiosity, and acceptance, and helps the individual to deeply understand their present experience. It has two main components: the ability to regulate attention and the ability to focus on the present moment with openness, curiosity, and acceptance. The stronger an individual's ability to maintain mindfulness while coping with life's challenges, the less negative the impact of emotional stress will be. In this context, it is reported that mindfulness-based exercises improve emotional resilience by increasing an individual's capacity to remain mindful. The ability to maintain awareness of life's circumstances has been the foundation of mindfulness practices for centuries and continues to be important in modern clinical practice.

The Mindfulness Based Stress Reduction (MBSR) protocol, developed by Jon Kabat-Zinn in the 1980s, pioneered the therapeutic use of mindfulness. This program aims to increase individuals' mindfulness to support their health and reduce stress.

It is thought that mindfulness-based approaches can be an effective alternative, especially in the management of psychological problems such as anxiety and depression, and can positively affect sleep quality by regulating aroused mental states before sleep.

While the current literature indicates that mindfulness-based interventions provide potential benefits in alleviating psychological and physical symptoms in postmenopausal women, the limited number of studies in the literature and methodological differences indicate that more randomized controlled trials are needed in this area. Based on current studies, the aim of this planned study is to examine the effect of mindfulness-based exercises on psychosomatic complaints such as anxiety, depression, and sleep quality in postmenopausal women.

The hypotheses of the study are as follows:

H0: Mindfulness-based exercises have no effect on anxiety, depression, and sleep quality in postmenopausal women.

H1: Mindfulness-based exercises have a positive effect on anxiety, depression, and sleep quality in postmenopausal women.

Вмешательства

• Другое Mindfulness-Based Stress Reduction Training
  Participants will be asked to attend standard group classes for one hour, six days a week. Meditation-based techniques will include breathing exercises, sitting meditations, and body scans. In week 6 of the program, individuals will undergo an eight-hour retreat, and will continue with the standard exercises for the remaining weeks. The goal of practicing mindfulness-based techniques daily is to ensure their effectiveness as a sustainable, lifelong intervention.

Первичные конечные точки

• The STAI I-II State and Trait Anxiety Scale [Срок оценки: Baseline (pre-intervention) and Week 8 (post-intervention)]
• Beck Anxiety Inventory [Срок оценки: Baseline (pre-intervention) and Week 8 (post-intervention)]
• Beck Depression Inventory [Срок оценки: Baseline (pre-intervention) and Week 8 (post-intervention)]
• The Pittsburgh Sleep Quality Scale [Срок оценки: Baseline (pre-intervention) and Week 8 (post-intervention)]

Критерии участия

Критерии включения

• Volunteering to participate in the study
• Being in the early postmenopausal period (no more than 8 years have passed since menopause)
• Having experienced natural menopause
• Having had at least one pregnancy
• Residing in Istanbul or Izmir provinces

Критерии исключения

• History of trauma or illness that would prevent exercise
• Having received hormone replacement therapy
• Being involved in a different exercise program
• Presence of a severe cardiopulmonary, orthopedic, or neurological disease
• Presence of a psychological or psychiatric diagnosis
• Presence of physical discomforts such as severe dizziness
• Cooperation problems and incompatibility

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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07424521 · karanki6

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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