Menopause and Compassionate Living Education

Официальное название

The Effect of Compassionate Living Education on Symptom Management and Quality of Life in Menopausal Women: A Randomized Controlled Study

Обзор

Menopause is a natural stage in a woman's life characterized by the permanent cessation of ovarian function and is frequently accompanied by vasomotor, psychological, urogenital, and sleep-related symptoms that can substantially impair quality of life. Although pharmacological treatments are available, many women seek non-pharmacological interventions to manage menopausal symptoms and improve their overall well-being. Mindfulness- and compassion-based interventions have shown promising effects on psychological health, stress reduction, and quality of life in different populations; however, evidence regarding the effectiveness of Mindfulness-Based Compassionate Living (MBCL) for women experiencing menopause remains limited. This randomized controlled trial aims to evaluate the effectiveness of a Compassionate Living Education Program based on the principles of Mindfulness-Based Compassionate Living in improving symptom management and quality of life among menopausal women. The study will be conducted with menopausal women recruited from primary healthcare settings in Kars, Türkiye. Participants who meet the eligibility criteria will be randomly assigned to either an intervention group or a control group. Participants in the intervention group will receive an eight-session online Compassionate Living Education Program delivered by a certified instructor. The program includes mindfulness practices, self-compassion exercises, breathing and relaxation techniques, compassionate imagery, loving-kindness meditation, and home practice assignments designed to strengthen emotional regulation, self-kindness, and adaptive coping skills. The control group will receive routine care only. Primary outcomes will include menopausal symptom severity and menopause-specific quality of life. Secondary outcomes will include self-compassion, mindfulness, anxiety, depression, and stress. Data will be collected using validated self-report questionnaires before and after the intervention and analyzed using appropriate statistical methods. The findings of this study are expected to provide evidence regarding the effectiveness of Compassionate Living Education as an accessible, low-cost, non-pharmacological intervention for improving symptom management and enhancing the quality of life of menopausal women. The results may contribute to the development of evidence-based nursing and women's health interventions in primary healthcare settings.

Подробное описание

Menopause is associated with physical, psychological, and social symptoms that may negatively affect women's quality of life. Effective non-pharmacological interventions are needed to improve symptom management during this period. Mindfulness-Based Compassionate Living (MBCL) has shown promising effects on psychological well-being and self-compassion in different populations. However, evidence regarding its effectiveness among menopausal women remains limited. This randomized controlled trial aims to evaluate the effects of Compassionate Living Education on menopausal symptom management and quality of life. Eligible participants will be randomly assigned to either an intervention group or a control group. The intervention group will participate in an eight-session online Compassionate Living Education Program, while the control group will receive routine care. Primary outcomes include menopausal symptom severity and menopause-specific quality of life. Secondary outcomes include self-compassion, mindfulness, anxiety, depression, and stress. The findings are expected to provide evidence for an accessible, low-cost, and evidence-based intervention to support women during the menopausal transition.

Вмешательства

• Поведенческое Session 1: How We Evolved - Threat, Impulse, and Soothing Systems
  The practice of "Breath break with kindness" will be applied for 5 minutes. Afterwards, 15 minutes of information on threats, impulses and soothing systems, "A safe place" application for 11 minutes, "Courtesy meditation" for 10 minutes. After each application, 10 minutes of feedback will be received from the participants.
• Поведенческое Session 2: Threat and Self-Compassion
  The practice of "breathing with kindness" will be done for 7 minutes. The practice of "Building a compassionate relationship with resilience" will be held for 12 minutes, and the practice of "Kindness meditation: a benevolent" will take place for 11 minutes. "A hand over your heart" application will be made for 3 minutes and "A compassionate comrade" application will be done for 10 minutes. After each application, 3 minutes of feedback will be received from the participants.
• Поведенческое Session 3: Unraveling the Knots of Desire and Patterns
  The practice of "breathing with kindness" will be done for 7 minutes. "Building a compassionate relationship with desire" 12 minutes, "Guided meditation to discover the inner pattern" 10 minutes and "Courtesy meditation: a good friend" 11 minutes. Except for the "breath break with kindness" application, 3 minutes of feedback will be received from the participants after each application
• Поведенческое Session 4: Internalizing compassion
  The "pretend-to-be" practice for the participants to observe themselves will be made for 10 minutes. The practice of "internalizing compassion" will be done for 7 minutes, "kindness meditation: a neutral person" practice for 10 minutes, and "kindness towards your body" for 10 minutes. After each application, 3 minutes of feedback will be received from the participants.
• Поведенческое Session 5: Me and others - Expanding the circle
  The "a compassionate letter" practice with the participants will continue for 15 minutes. "meditation: the 'difficult' person" 8 minutes, "compassion and breathing: yourself" 10 minutes and "compassionate breathing: others" 7 minutes. A "compassionate break" application is performed for 7 minutes.
• Поведенческое Session 6: Growing happiness
  The practice of "Revisiting the good" is carried out for 10 minutes with the participants. "Forgive yourself", "wish for forgiveness", "forgive others", "gratitude" practices will be held for 5 minutes each and will take 20 minutes in total. "Courtesy meditation: groups and all beings" will be practiced for 10 minutes. After each application, 3 minutes of feedback will be received from the participants
• Поведенческое Session 7: Weaving Wisdom and Compassion into Daily Life
  Participants will be given 10 minutes to choose a day in their life and allow a few minutes to pause mindfully. The practice of "a breather for wise and compassionate action" is 10 minutes, the practice of "calmness meditation" is 8 minutes, and the practice of "sharing the joy meditation" is 8 minutes. After each application, 3 minutes of feedback will be received from the participants.
• Поведенческое Session 8: Living with the Heart
  The participants are told about the applications they can apply for, where they need help to develop compassion towards self-healing skills, and the entire training will be evaluated for 20 minutes. The "river of life" application is carried out for 20 minutes. 10 minutes of feedback will be received after the application.

Первичные конечные точки

• Menopausal Symptom Assessment Scale/MSSA (Appendix-2) [Срок оценки: up to 1 day]

Вторичные конечные точки (1)

• Menopause-Specific Quality of Life Scale (MSQLS) (Appendix-3) [Срок оценки: up to 1 day]

Критерии участия

Критерии включения

• Women who are in the menopausal period.
• Aged 45 years or older.
• Registered at the participating primary healthcare center.
• Able to read and understand Turkish.
• At least a primary school graduate.
• Willing to participate and provide written informed consent.
• Able to attend the online Compassionate Living Education sessions.
• Able to complete the study questionnaires.

Критерии исключения

• Failure to complete the study questionnaires.
• Failure to attend the Compassionate Living Education sessions.
• Withdrawal of informed consent at any stage of the study.
• Inability to complete the post-intervention assessment.

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

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Ataturk University Vocational School of Health Services — Erzurum

Идентификаторы

NCT: NCT07728461 · MCENGİZ8

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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