Clinical trial NCT06892509: The Effect of Mindfulness Practice on Quality of Life, Life Satisfaction, Sleep Quality and Mental Well-being Levels in Menopausal Women
Official title: The Effect of Mindfulness-Based Stress Reduction Programme (MBSR) on Quality of Life, Satisfaction with Life, Sleep Quality and Mental Well-Being of Menopausal Women: a Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mindfulness Based Stress Reduction
Keywords: Mindfulness-based stress reduction programme
Menopause
Mental well-being
Sleep quality
Life satisfaction
Quality of life
Lead sponsor: Agri Ibrahim Cecen University
Sponsor class: OTHER
Collaborators: name: Ataturk University
First posted: 2025-03-24
Enrollment: 90
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Although menopause is a normal physiological process in women's lives, it is often accompanied by physical and emotional symptoms that can negatively affect women's quality of life. Hot flushes and night sweats, physical discomfort, sleep disturbances, increased anxiety, irritability, depressive symptoms, fatigue are among the most common and disturbing menopausal symptoms. In order to have a healthy and happy menopause and postmenopausal period, reducing women's complaints during this period will improve their quality of life. Recently, women are increasingly turning to non-hormonal, complementary and alternative methods to improve their quality of life. One of these methods is mindfulness-based stress reduction programme. Studies examining the effects of mindfulness-based stress reduction programme on menopausal women are limited. Studies in Turkey have examined the effects of mindfulness-based stress reduction programme on quality of life, anxiety, depression and menopausal complaints, but there is no study on the effects on life satisfaction, sleep quality and mental well-being. This study aims to fill the gap in the literature by examining the effects of a mindfulness-based stress reduction programme on Turkish women. It was found that important parameters such as quality of life, life satisfaction, sleep quality and mental well-being decline during menopause. It is aimed to alleviate these problems with a mindfulness-based stress reduction programme and contribute to the active healthy aging process of women. The results of this study will contribute to the United Nations Sustainable Development Goals such as 'Healthy Individuals' and 'Gender Equality' by providing new strategies to improve the quality of life of menopausal women. It is also aimed to contribute to improving women's health and increasing the capacity of health services for active ageing by 2030. This study will be conducted on 90 women between the ages of 45-64 who have not had menstrual bleeding for at least one year and who volunteered to participate in the study, 45 of whom will be experimental and 45 of whom will be control, who applied to Ağrı Central Family Health Centre No. 6 in Ağrı province. The pre-test data of the women in the experimental and control groups, who were randomly assigned to the study, will be collected with the 'Descriptive Information Form', 'Utian Quality of Life Scale', 'Riverside Satisfaction with Life Scale', 'Pittsburgh Sleep Quality Scale' and 'Warwick-Edinburgh Mental Well-Being Scale'. The women in the experimental group will be given a mindfulness-based stress reduction programme. No intervention will be given to the control group. The post-test data will be collected from the women in the experimental and control groups after eight weeks. The data of the experimental and control groups (coded as X and Y) will be transferred to the computer environment by a statistician independent from the research and the data will be analysed and the findings will be reported.

Detailed description: Experimental Group: Women in the experimental group will be given mindfulness-based stress reduction programme.

Control Group: No action will be taken.

Women who meet the inclusion criteria will be informed about the purpose, content and application of the study, and women in the experimental and control groups will be included in the study. At this stage, Personal Information Form, Utian Quality of Life Scale, Riverside Satisfaction with Life Scale, Pittsburgh Sleep Quality Scale, Warwick-Edinburgh Mental Well-Being Scale will be filled in both groups.

Informed consent will be obtained from the women at the end of the information process. Women will be assigned to the experimental and control groups using a simple randomisation table on the website www.random.org. Personal Information Form, Utian Quality of Life Scale, Riverside Satisfaction with Life Scale, Pittsburgh Sleep Quality Scale, Warwick-Edinburgh Mental Well-Being Scale will be applied to both groups. Women in the experimental group will also be given mindfulness training.

Eligibility criteria: Inclusion Criteria:

* Who agreed to participate in the research,
* Can read and write Turkish,
* Not diagnosed with a psychiatric illness,
* 45-64 years of age with no menstrual bleeding for at least one year,
* Using any CAM method (such as Reiki, phytoestrogens, acupressure),
* Women who score above 5 points on the Pittsburgh Sleep Quality Scale will be included.

Exclusion Criteria:

* Voluntary withdrawal from the research,
* Taking antidepressants, antihistamines, benzodiazepines, hypnotics, narcotics, etc,
* Women who started to use any CAM method (such as Reiki, phytoestrogens, acupressure) will be excluded from the study.

Primary outcomes:
measure: Utian Quality of Life Scale
timeFrame: This form will be collected on day 1. The experimental group will be given mindfulness-based stress reduction training for 2 months. After the trainings are completed, the form will be applied again.
measure: Riverside Satisfaction with Life Scale
timeFrame: This form will be collected on day 1. The experimental group will be given mindfulness-based stress reduction training for 2 months. After the trainings are completed, the form will be applied again.
measure: Pittsburgh Sleep Quality Scale
timeFrame: This form will be collected on day 1. The experimental group will be given mindfulness-based stress reduction training for 2 months. After the trainings are completed, the form will be applied again.
measure: Warwick - Edinburgh Mental Well-being Scale
timeFrame: This form will be collected on day 1. The experimental group will be given mindfulness-based stress reduction training for 2 months. After the trainings are completed, the form will be applied again.
Secondary outcomes:
Other outcomes:
Locations:
city: Ağrı
country: Turkey
facility: AgriIbrahimCecenU
Study officials:
References: