The Effect Of Mındfulness-Based and Occupatıonal Practıces On Psychologıcal Well-Beıng and Menopausal Symptoms In Menopausal Women: A Randomısed Controlled Trıal
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Psychological Well-Being Scale
研究概览
简要总结
Non-drug methods are frequently preferred in menopausal symptoms, especially in mental effects, and their effectiveness on symptoms is remarkable. Non-drug methods mainly used in the management of postmenopausal symptoms are sports, avoiding bad habits, paying attention to diet and increasing fluid intake, wearing comfortable clothes. In addition, there are many supportive methods such as stress reduction meditation practices, garden therapies, breathing and physical exercise practices, aromatherapy. Among the most frequently used coping methods of women experiencing menopausal symptoms such as irritability and anxiety/anxiety, it was found that 'paying attention to different things (housework, cleaning, cooking, handicrafts, etc.)' was among the most frequently used coping methods. In this direction, it is thought that occupational practice may have positive effects on menopausal symptoms in women. Engagement practices are one of the methods widely used in recent years to cope with anxiety, depression and stress.
Our study aimed to measure the effectiveness of mindfulness-based practices on menopausal symptoms and psychological well-being in menopausal women by blending mindfulness-based practices and busyness practices, and in this sense, it is anticipated that it will make a significant contribution to the literature.
Objective: This study will be conducted to determine the effect of mindfulness-based and occupational practices on psychological well-being and menopausal symptoms in menopausal women.
Materials and Methods: The research will be conducted as a randomised controlled experimental study in a four-group, parallel, pretest-posttest design. The research is planned to be conducted between December 2024 and December 2025. The population of the study consists of women in menopause who applied to the ASM in the centre of Kars between December 2024 and December 2025. The sample of the study will consist of women who meet the inclusion criteria among these women. As a result of the power analysis performed in the G*Power version 3.1.9.7 programme, it was determined that a total of 76 participants, at least 19 people in each of the intervention and control groups, with a sample size, 95% confidence, 95% test power (1-ß), 0.05% margin of error level, d = 0.25 effect size (Kang, 2021). Considering 10% possible data loss in the study, it was planned to include 20 women in each of the intervention and control groups.
详细描述
The transition from the reproductive period to post-reproductive life in women is called menopausal transition and is an important turning point in a woman's life cycle. Most women experience menopausal symptoms during this period and the majority of these symptoms are severe and long-lasting. Vasomotor symptoms in women can disrupt sleep, cause forgetfulness and fatigue, as well as mental changes, increase anxiety and create conditions such as depressive mood.
Non-drug methods are frequently preferred in menopausal symptoms, especially in mental effects, and their effectiveness on symptoms is remarkable. Non-drug methods mainly used in the management of postmenopausal symptoms are sports, avoiding bad habits, paying attention to diet and increasing fluid intake, wearing comfortable clothes. In addition, there are many supportive methods such as stress reduction meditation practices, garden therapies, breathing and physical exercise practices, aromatherapy. Among the most frequently used coping methods of women experiencing menopausal symptoms such as irritability and anxiety/anxiety, it was found that 'paying attention to different things (housework, cleaning, cooking, handicrafts, etc.)' was among the most frequently used coping methods. In this direction, it is thought that occupational practice may have positive effects on menopausal symptoms in women. Engagement practices are one of the methods widely used in recent years to cope with anxiety, depression and stress.
Our study aimed to measure the effectiveness of mindfulness-based practices on menopausal symptoms and psychological well-being in menopausal women by blending mindfulness-based practices and busyness practices, and in this sense, it is anticipated that it will make a significant contribution to the literature.
Objective
This study will be conducted to determine the effect of mindfulness-based and occupational practices on psychological well-being and menopausal symptoms in menopausal women.
Materials and Methods
The research will be conducted as a randomised controlled experimental study in a four-group, parallel, pretest-posttest design. The research is planned to be conducted between December 2024 and December 2025. The population of the study consists of women in menopause who applied to the ASM in the centre of Kars between December 2024 and December 2025. The sample of the study will consist of women who meet the inclusion criteria among these women. As a result of the power analysis performed in the G*Power version 3.1.9.7 programme, it was determined that a total of 76 participants, at least 19 people in each of the intervention and control groups, with a sample size, 95% confidence, 95% test power (1-ß), 0.05% margin of error level, d = 0.25 effect size (Kang, 2021). Considering 10% possible data loss in the study, it was planned to include 20 women in each of the intervention and control groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Volunteering to participate in the research,
- •Knowing how to read and write Turkish,
- •Do not be in menopause,
- •Having a smart mobile phone,
排除标准
- •Don't take hormone therapy,
- •The presence of a diagnosed psychiatric illness,
- •Visual, hearing, speech, physical or mental disability,
- •Interruption of the application made within the scope of Engagement Practices,
- •Taking psychiatric medication (antidepressants, benzodiazepines, hypnotics, narcotics, etc.), Using any other CAM method (such as Reiki, phytoestrogens, acupressure).
结局指标
主要结局
Psychological Well-Being Scale
时间窗: Eight weeks
The scale developed by Dinner in 2009 to measure the level of psychological well-being is a 7 Likert scale consisting of 8 items. The Turkish validity and reliability of the scale was conducted in 2013. Psychological Well-being Scale defines important elements of human functioning such as positive relationships, self-efficacy perception, having a meaningful and purposeful life. The score obtained from the scale varies between 8-56. A high score indicates that the person has many psychological resources and strengths. Cronbach's alpha coefficient of the scale was found to be 0.80.
The menopause Rating Scale (MRS)
时间窗: Eight weeks
MSDS was developed by Schneider et al. in 1992. Turkish validity and reliability study was conducted in 2005. The CDSS consists of 11 items and 3 sub-dimensions. The sub-dimensions are named as 'Somatic Complaints', 'Psychological Complaints', 'Urogenital Complaints'. The scale is answered in 5-point Likert scale and each statement is scored as 0: None, 1: Mild, 2: Moderate, 3: Severe and 4: Very severe. The lowest score that can be obtained from the whole scale is 0 and the highest score is 44. An increase in the total score obtained from the scale indicates an increase in the severity of the complaints experienced and a negative impact on the quality of life. The cronbach alpha reliability coefficient of the original scale is 0.84. The cronbach alpha values of the subgroups are 0.65 for somatic complaints, 0.79 for psychological complaints and 0.72 for urogenital complaints.
次要结局
未报告次要终点
研究者
Şafak AYDİN
ASSISTANT PROFESSOR
Kafkas University