Effects of Mindfulness-Based Self-Efficacy Development Program on Menopausal Symptoms and Quality of Life in Postmenopausal Women: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in menopausal symptom severity
研究概览
简要总结
The aim of this randomized controlled clinical trial is to evaluate the effects of a mindfulness-based self-efficacy development program on menopausal symptoms and quality of life in postmenopausal women. The main questions it aims to answer are:
Does the mindfulness-based program reduce the severity of menopausal symptoms?
Does the mindfulness-based program improve the quality of life of postmenopausal women?
Does the mindfulness-based program significantly increase participants' overall self-efficacy?
The researchers will compare whether there are differences between the mindfulness-based training program applied to the intervention group and the control group in terms of menopausal symptoms, quality of life, and self-efficacy scores.
The main tasks that will be asked of the participants are as follows:
Those in the intervention group will participate in a face-to-face mindfulness-based self-efficacy development program, each session lasting at least 120 minutes, once a week for 8 weeks, with a maximum of 10 people per group.
The control group will not receive any intervention.
Participants in both groups will be evaluated with a personal information form and measurement tools such as the Menopause Symptoms Assessment Scale, the Menopause Specific Quality of Life Scale, and the General Self-efficacy Scale.
详细描述
This research is a randomized controlled experimental study aiming to evaluate the effects of a mindfulness-based self-efficacy development program on menopausal symptoms and quality of life in women during menopause. The research will be conducted at Lokman Hekim University Etlik Hospital between September 2025 and March 2026.
Postmenopausal women who have entered menopause naturally, who do not have a physical disability that prevents them from participating in mindfulness practices, who are literate and literate in Turkish, and who have access to technology will be included in the study. Participants will be assigned to the intervention and control groups by simple randomization.
Participants in the intervention group will receive an eight-week mindfulness-based self-efficacy development training based on Kabat-Zinn's Mindfulness-Based Stress Reduction (MBSR) program. Sessions will be held face-to-face once a week for 90-120 minutes. The program consists of components such as breath awareness, focusing on bodily sensations, mindful movement, working with emotions, and present-moment awareness.
Standard scales will be applied to all participants before and after the study to assess menopausal symptoms, quality of life and general self-efficacy levels. The collected data will be compared statistically.
This study aims to be an original study to evaluate whether a mindfulness-based self-efficacy development program has the potential to help control menopausal symptoms and improve quality of life in postmenopausal women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
In this study, blinding could not be done due to the nature of the study. Since the intervention program will be carried out directly by the researcher, the participants and the researcher will know which group is the intervention and which is the control group. However, in order to ensure impartiality in the data analysis process, the obtained data will be coded (Group 1-Group 2) and forwarded to an independent statistician and the statistical analyses will be performed by this expert without knowing the groups. Thus, it was aimed to prevent biases that may occur during the analysis phase by blinding the statistician.
入排标准
- 年龄范围
- 45 Years 至 57 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •Individuals who are in the +1a or +1b substage of early postmenopause according to the STRAW+10 system (at least 12 months and at most 24 months have passed since their last menstrual period)
- •Are proficient in reading and writing Turkish
- •Are in a spouse or partner
- •Have entered menopause naturally
- •Do not have a physical disability such as a severe musculoskeletal disorder, neurological disease, or mobility limitation that would prevent the use of mindfulness techniques (e.g., seated meditation, breathing exercises, gentle body awareness exercises)
- •Have not used MBSR techniques in the last six months
- •Own a smartphone or internet-enabled device.
排除标准
- •Those who completed the pretest data collection forms incompletely,
- •Those who had any psychological disorder or experienced a traumatic event in the last two to one years,
- •Those who received hormone replacement therapy during menopause,
- •Those who had any gynecological cancer
研究组 & 干预措施
Intervention Group
In the Mindfulness-Based Self-Efficacy Development Program, it is planned that the training groups will consist of a maximum of 10 people.
The trainings will be structured as 90-120 minute sessions, 1 day a week, for a total of 8 weeks. Each session will be carried out through face-to-face training.
The program content is structured based on Kabat-Zinn's Mindfulness-Based Stress Reduction (MBSR) protocol. The program focuses on breath awareness, focusing on bodily sensations, moving with awareness, eating with awareness and mindfulness in daily activities, coping with thoughts, emotions and stressful situations with awareness, and the present moment as a safe space within the framework of the basic components of self-compassion, intention and attitude.
Each session will include story content appropriate to the main theme of the session. The trainings applied to the intervention group were prepared within the scope of the "Mindfulness-Based Self-Efficacy Development Program" and the co
干预措施: Mindfulness-Based Self-Efficacy Development Program (Behavioral)
Control Group
The participants in the control group will be administered the measurement tools applied to the intervention group at the beginning of the study. At the end of the 8-week follow-up period, the same scales applied in the pre-test will be re-administered and interim test data will be collected. Thus, the level of change in the control group will be evaluated comparatively with the intervention group. Following the completion of the 4-week home practice applications of the intervention group, post-test data will be collected from the control group. No intervention will be applied to the participants in the control group during the study. However, in accordance with ethical principles, the content program of the sixth week of the eight-week mindfulness training applied to the intervention group will be presented to the women in the control group after the study is completed. In addition, training brochures shared with the intervention group will be provided.
结局指标
主要结局
Change in menopausal symptom severity
时间窗: Pre-intervention, post-intervention (week 8), follow-up (week 12)
The severity of menopausal symptoms will be measured using the Menopausal Symptoms Rating Scale. The scale covers psychological, urogenital, and somatic dimensions. The Likert-type scale, consisting of 11 items covering menopausal complaints, includes options for each item: 0: None at all, 1: Mild, 2: Moderate, 3: Severe, and 4: Very severe. The total scale score is calculated based on the scores given for each item. The minimum possible score is 0, while the maximum is 44. A higher score indicates both an increase in the severity of menopausal symptoms and a negative impact on quality of life.
Change in quality of life
时间窗: Pre-intervention, post-intervention (8th week), follow-up (12th week)
Quality of life will be assessed with the Menopause-Related Quality of Life Scale (MENQOL). The scale includes vasomotor, psychosomatic, psychological and sexual life subscales. As the scores increase, the severity of the problems experienced increases. Lower scores indicate higher quality of life. On the MÖYKÖ-II, each subdomain score is ranked from 0 to 6. Women are asked to answer "no" or "yes" regarding any complaints they have experienced in the past month. If the answer is "yes," the participant scores each symptom on a scale of 0-6, indicating its presence. A "none" indicates that the symptom is not experienced, a "none" indicates that the symptom is present, and scores of 1-6 indicate the severity and increasing severity of the problem. The researcher scores each item on a scale of 1 to 8, including "none" and "none." The minimum score for each item is 1, and the maximum is 8. The minimum score for the total scale is 29, and the maximum is (29X8) 232.
Change in self-efficacy level
时间窗: Pre-intervention, post-intervention (8th week), follow-up (12th week)
Women's self-efficacy perceptions will be measured using the General Self-Efficacy Scale (GSES). The GSES is a 17-item Likert-type scale with a minimum score of 17 and a maximum score of 85. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, and 17 are reverse-scored. Higher scores indicate higher self-efficacy beliefs. The scale consists of three subscales: initiation, perseverance, and persistence.
Change in menopausal symptom severity
时间窗: Pre-intervention, post-intervention (week 8), follow-up (week 12)
The severity of menopausal symptoms will be measured using the Menopausal Symptoms Rating Scale. The scale covers psychological, urogenital, and somatic dimensions. The Likert-type scale, consisting of 11 items covering menopausal complaints, includes options for each item: 0: None at all, 1: Mild, 2: Moderate, 3: Severe, and 4: Very severe. The total scale score is calculated based on the scores given for each item. The minimum possible score is 0, while the maximum is 44. A higher score indicates both an increase in the severity of menopausal symptoms and a negative impact on quality of life.
Change in quality of life
时间窗: Pre-intervention, post-intervention (8th week), follow-up (12th week)
Quality of life will be assessed with the Menopause-Related Quality of Life Scale (MENQOL). The scale includes vasomotor, psychosomatic, psychological and sexual life subscales. As the scores increase, the severity of the problems experienced increases. Lower scores indicate higher quality of life. On the MÖYKÖ-II, each subdomain score is ranked from 0 to 6. Women are asked to answer "no" or "yes" regarding any complaints they have experienced in the past month. If the answer is "yes," the participant scores each symptom on a scale of 0-6, indicating its presence. A "none" indicates that the symptom is not experienced, a "none" indicates that the symptom is present, and scores of 1-6 indicate the severity and increasing severity of the problem. The researcher scores each item on a scale of 1 to 8, including "none" and "none." The minimum score for each item is 1, and the maximum is 8. The minimum score for the total scale is 29, and the maximum is (29X8) 232.
Change in self-efficacy level
时间窗: Pre-intervention, post-intervention (8th week), follow-up (12th week)
Women's self-efficacy perceptions will be measured using the General Self-Efficacy Scale (GSES). The GSES is a 17-item Likert-type scale with a minimum score of 17 and a maximum score of 85. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, and 17 are reverse-scored. Higher scores indicate higher self-efficacy beliefs. The scale consists of three subscales: initiation, perseverance, and persistence.
次要结局
未报告次要终点
研究者
Nurcan Gökgöz
nurse
Lokman Hekim Üniversitesi