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Menopause and Compassionate Living Education

2026年7月22日 更新者:Mine CENGİZ、Ataturk University

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

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

68

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Yakutiye
      • Erzurum、Yakutiye、土耳其(türkiye)
        • Ataturk University Vocational School of Health Services
        • 接触:
        • 副研究员:
          • Sibel Öztürk, Assoc. prof.
        • 副研究员:
          • Nazlı Sezer, Assistant Professor

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:第一场会议:我们如何进化——威胁、冲动与安抚系统
• 练习“善意的呼吸停顿”。 • 鼓励他们思考威胁、冲动和镇静系统在自己生活中是如何形成的。 • 进行“安全之地”的应用练习。 • 完成“礼貌冥想”。
“善良的呼吸破裂”的做法将持续5分钟。 之后,有关威胁,冲动和舒缓系统的15分钟信息,“安全的地方”申请11分钟,“礼貌冥想” 10分钟。 每次申请后,将从参与者那里收到10分钟的反馈。
实验性的:第二场:威胁与自我关怀
• 实践“带着善意的呼吸休息”。 • 进行“与韧性建立慈悲关系”和“善意冥想:仁慈”的练习。 • 进行“手放心上”和“慈悲同伴”的练习。
练习“慈悲呼吸”7分钟。 “建立富有韧性的慈悲关系”练习将进行12分钟,“仁慈冥想:仁慈”练习将进行11分钟。 “交出你的心”申请时间为3分钟,“爱心同志”申请时间为10分钟。 每次申请后,将收到参与者 3 分钟的反馈。
实验性的:第三场:解开欲望与模式之结的议程
• 讨论家庭作业。 • 练习“善意的呼吸暂停”。 • 进行“与欲望建立慈悲关系”、“引导冥想以发现内在模式”、“礼貌冥想:一位好朋友”的练习。
“善良呼吸”的做法将进行7分钟。 “与欲望建立富有同情心的关系” 12分钟,指导冥想发现内在模式” 10分钟和“礼貌冥想:好朋友” 11分钟。 除了“善良的呼吸休息”应用程序,每次申请后,参与者将收到3分钟的反馈
实验性的:第四场:内化慈悲
• “假装游戏”练习旨在让参与者观察自己。 • 除了之前的练习,还进行“内化慈悲”练习,以增强他们的扩展正念。 • 礼貌冥想:一位中立人士”,即“对身体友善”,基于正念练习,增强身体意识和正念运动,将被执行。 白天,他们将被告知应自行进行“友善行走”练习。
为期10分钟的“假装”练习让参与者观察自己。 “慈悲内化”练习7分钟,“善行冥想:中性人”练习10分钟,“善待你的身体”练习10分钟。 每次申请后,将收到参与者 3 分钟的反馈。
实验性的:第5节:我与他人——扩大圈子
• “慈悲信函”申请是通过让参与者思考近期或早些时候遇到且仍令人痛苦的情况来完成的。 解释说明他们可以通过此申请获得洞察。 • 进行“礼貌冥想:'困难'之人”、“慈悲与呼吸:自己”以及“慈悲呼吸:他人”的练习
与参与者一起进行的“一封富有同情心的信”练习将持续15分钟。 “冥想:‘困难’的人”8分钟,“慈悲与呼吸:你自己”10分钟,“慈悲呼吸:他人”7分钟。 “同情休息”申请持续 7 分钟。
实验性的:第6节:培养幸福
• 开展“重温美好”练习,为参与者定义五种感官。 • 开展“宽恕”、“请求宽恕”、“宽恕他人”、“感恩”练习。 • 练习扩展为“慈心禅修:群体与众生”
“重新审视善”的做法与参与者进行了10分钟。 “原谅自己”,“愿意宽恕”,“宽恕他人”,“感激”的做法将每次举行5分钟,总共需要20分钟。 “礼貌的冥想:团体和所有生物”将进行10分钟。 每次申请后,将从参与者那里收到3分钟的反馈
实验性的:第七场:将智慧与慈悲融入日常生活
• 参与者被要求选择生活中的一天,并留出几分钟以正念的方式暂停。 • 进行“明智与慈悲行动之喘息”、“平静冥想”和“喜悦分享冥想”练习。
参与者将有 10 分钟的时间选择自己生活中的一天,并留出几分钟的时间认真思考。 “慧慈行息”练习10分钟,“平静禅修”练习8分钟,“分享喜悦禅修”练习8分钟。 每次申请后,将收到参与者 3 分钟的反馈。
实验性的:第8场:与心脏共处
• 参与者被告知可申请的应用程序,他们需要帮助来开发自我愈合技能的慈悲心,并对整个培训进行评估。 • 实施了“生命之河”应用程序,该程序深度评估正念。 • 对该八次训练的研究进行总结,并收集反馈。
参与者被告知他们可以申请哪些应用,他们需要帮助来培养对自我治疗技能的同情心,整个培训将在 20 分钟内进行评估。 “生命之河”应用进行20分钟。 申请后将收到10分钟的反馈。

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Menopausal Symptom Assessment Scale/MSSA (Appendix-2)
大体时间:up to 1 day
Developed by Schneider et al. in 1992 to measure the severity of menopausal symptoms and their impact on quality of life, the Turkish validity and reliability of this scale was established by Gürkan (Gürkan, 2005). The scale, consisting of 11 items covering menopausal complaints, comprises 3 sub-dimensions: 1- Somatic complaints (items 1, 2, 3, 11), 2- Psychological complaints (items 4, 5, 6, 7), and 3- Urogenital complaints (items 8, 9, 10). The scale uses a 5-point Likert scale, with each item scored from 0: None, 1: Mild, 2: Moderate, 3: Severe, and 4: Very severe. The total score of the scale is calculated based on the scores given for each item. The minimum score obtainable from the scale is 0, while the maximum score is 44. An increase in the total score obtained from the scale indicates an increase in the severity of the complaints experienced, and on the other hand, it shows that the quality of life is negatively affected.
up to 1 day

次要结果测量

结果测量
措施说明
大体时间
Menopause-Specific Quality of Life Scale (MSQLS) (Appendix-3)
大体时间:up to 1 day
Developed by Hilditch et al. (1996), its Turkish validity and reliability were established by Kharbouch and Şahin (2007). The MSQLS consists of four sub-dimensions: vasomotor, psychosocial, physical, and sexual, and contains 29 statements on a six-point Likert scale. In the MSQLS, each sub-area is scored between 0-6. A score of "0" indicates that no problems are experienced regarding the issue, a score of "1" indicates that the problem exists but does not bother anyone, and scores between "2-6" indicate the severity and increasing degree of the existing problem. The lowest possible score on the scale is "0", and the highest is 154. An increase in the score obtained from the MÖYKÖ indicates an increase in the severity of the complaint and a decrease in quality of life. The MÖYKÖ is not evaluated based on the total score. In the original study, the Cronbach's alpha values for the sub-dimensions of the scale were found to b
up to 1 day

其他结果措施

结果测量
措施说明
大体时间
Self-Compassion Scale Short Form (SCS-S) (Appendix-4)
大体时间:up to 1 day
Developed by Neff (2003), the scale's Turkish validity and reliability were established by Yıldırım and Sarı in 2018. The scale was confirmed to consist of 11 items, a single dimension, and two complementary components (positive and negative components). The internal consistency coefficient of the scale was calculated as 0.75. The SCS-S is recommended for use in research where total scores are used to measure self-compassion.
up to 1 day
Mindfulness Awareness Scale (MAS) (Appendix-5)
大体时间:up to 1 day
Developed by Brown and Ryan (2003) to assess individuals' level of mindfulness. Its Turkish validity and reliability were established by Özyeşil et al. (2011). The scale is a 15-item, single-dimensional scale using a six-point Likert scale. The Cronbach's alpha coefficient of the scale was determined to be 0.80. The minimum and maximum scores individuals can obtain on the scale range from 15 to 90. Higher scores indicate a high level of cognitive impairment.
up to 1 day

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月30日

初级完成 (估计的)

2026年12月15日

研究完成 (估计的)

2027年1月30日

研究注册日期

首次提交

2026年7月22日

首先提交符合 QC 标准的

2026年7月22日

首次发布 (实际的)

2026年7月27日

研究记录更新

最后更新发布 (实际的)

2026年7月27日

上次提交的符合 QC 标准的更新

2026年7月22日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • MCENGİZ8

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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