An interventional study of Mindfulness-Based Stress Reduction Training in Psychosocial Functioning, Mindfulness and Postmenopausal Symptoms, sponsored by Halic University. Not yet recruiting. Open to female participants aged 45 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by Halic University · Not applicable, Interventional, and Treatment
Menopause is a natural biological process characterized by the permanent cessation of the menstrual cycle in women. Hormonal changes associated with menopause commonly lead to mood swings, anxiety, depression, stress, and decreased sleep quality in women. While the current literature indicates that mindfulness-based interventions offer potential benefits in alleviating psychological and physical symptoms in postmenopausal women, the limited number of studies in the literature and methodological differences suggest a need for more randomized controlled trials in this area. The aim of this study is to examine the effect of mindfulness-based exercises on psychosomatic complaints such as anxiety, depression, and sleep quality in postmenopausal women. Designed as a randomized controlled experimental study, it was planned to include at least 20 women in the early postmenopausal period residing in Istanbul and Izmir between March and June 2026. The women included in the study will be randomized into Group 1 (n=10), which will perform mindfulness-based exercises, and Group 2 (n=10), which will receive no intervention as usual. The STAI I-II Form State and Trait Anxiety Scale and Beck Anxiety Inventory will be used to assess state and anxiety level, the Beck Depression Scale for depression level, and the Pittsburgh Sleep Quality Scale for sleep quality.
Continuous variables will be presented as mean ± standard deviation, and qualitative variables as number and percentage (%). If parametric test assumptions are met, the Independent Samples t-test will be used to compare independent groups, and the Paired Samples t-test will be used to compare dependent groups. If parametric test assumptions are not met, the Mann-Whitney U test will be used to compare independent groups, and the Wilcoxon test will be used to compare dependent groups. Statistical significance will be set at p≤0.05. This study is expected to contribute to the literature by providing evidence-based data on the effectiveness of mindfulness-based exercises on common psychological symptoms in the postmenopausal period.
Menopause is a natural biological process characterized by the permanent cessation of the menstrual cycle, beginning with the absence of menstruation for 12 consecutive months following a woman's last menstrual bleeding. The basic physiological mechanism of menopause is related to the increase in follicle-stimulating hormone (FSH) levels and the decrease in estrogen levels. This period brings about many biological, physical, and psychological changes, along with changes in reproductive functions. With the decrease in estrogen levels, reproductive functions are lost, leading to various changes in women. The decrease in estradiol and inhibin levels and the increase in FSH and luteinizing hormone levels during the menopausal transition period lead to several physical and psychological effects in women, primarily including impaired sleep quality. Hormonal changes associated with menopause most frequently lead to mood swings, anxiety, depression, stress, and decreased quality of life in women. It is also reported that problems such as hot flashes, sweating, especially in the facial area, sexual dysfunction, increased hair growth, skeletal disorders, osteoporosis, appetite changes and weight problems, difficulty concentrating, and vaginal itching are commonly observed. Problems occurring in this new phase of an individual's life can negatively affect the daily lives and functions of postmenopausal women, creating a need for effective coping with the encountered problems.
Mindfulness refers to an individual's ability to focus on their sensations, thoughts, physical condition, state of consciousness, and environment with non-judgmental awareness. This approach is characterized by fundamental qualities such as openness, curiosity, and acceptance, and helps the individual to deeply understand their present experience. It has two main components: the ability to regulate attention and the ability to focus on the present moment with openness, curiosity, and acceptance. The stronger an individual's ability to maintain mindfulness while coping with life's challenges, the less negative the impact of emotional stress will be. In this context, it is reported that mindfulness-based exercises improve emotional resilience by increasing an individual's capacity to remain mindful. The ability to maintain awareness of life's circumstances has been the foundation of mindfulness practices for centuries and continues to be important in modern clinical practice.
The Mindfulness Based Stress Reduction (MBSR) protocol, developed by Jon Kabat-Zinn in the 1980s, pioneered the therapeutic use of mindfulness. This program aims to increase individuals' mindfulness to support their health and reduce stress.
It is thought that mindfulness-based approaches can be an effective alternative, especially in the management of psychological problems such as anxiety and depression, and can positively affect sleep quality by regulating aroused mental states before sleep.
While the current literature indicates that mindfulness-based interventions provide potential benefits in alleviating psychological and physical symptoms in postmenopausal women, the limited number of studies in the literature and methodological differences indicate that more randomized controlled trials are needed in this area. Based on current studies, the aim of this planned study is to examine the effect of mindfulness-based exercises on psychosomatic complaints such as anxiety, depression, and sleep quality in postmenopausal women.
The hypotheses of the study are as follows:
H0: Mindfulness-based exercises have no effect on anxiety, depression, and sleep quality in postmenopausal women.
H1: Mindfulness-based exercises have a positive effect on anxiety, depression, and sleep quality in postmenopausal women.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 20 is below the median of 81 across 7,063 interventional studies indexed under Depression.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This represents the group that will receive mindfulness-based training for 8 weeks.
Other: Mindfulness-Based Stress Reduction Training
This represents the control group, where no intervention is applied, as is the case in routine training.
Participants will be asked to attend standard group classes for one hour, six days a week. Meditation-based techniques will include breathing exercises, sitting meditations, and body scans. In week 6 of the program, individuals will undergo an eight-hour retreat, and will continue with the standard exercises for the remaining weeks. The goal of practicing mindfulness-based techniques daily is to ensure their effectiveness as a sustainable, lifelong intervention.
The STAI I-II State and Trait Anxiety Scale
The STAI I-II State and Trait Anxiety Scale is a psychological inventory consisting of 40 self-report items that measure participants' anxiety levels. It measures two types of anxiety: state anxiety and trait anxiety. Total scores from both scales range from 20 to 80. Higher scores are directly proportional to higher anxiety levels. Validity and reliability studies were conducted by Öner and LeCompte in 1977.
Time frame: Baseline (pre-intervention) and Week 8 (post-intervention)
Beck Anxiety Inventory
Beck Anxiety Inventory (BAI) is a 21-item self-assessment scale designed to measure an individual's anxiety level. Each item is scored from 0 to 3, with a maximum total score of 63. Scores between 0 and 7 indicate minimal anxiety, 8-15 mild anxiety, 16-25 moderate anxiety, and 26 or higher indicates severe anxiety. The Turkish validity and reliability study of the scale was conducted by Ulusoy et al.
Time frame: Baseline (pre-intervention) and Week 8 (post-intervention)
Beck Depression Inventory
Beck Depression Inventory (BDI): Developed in 1961 by Beck and colleagues, this is a 21-item self-assessment scale used to measure the level of depressive symptoms. Each item on the scale is worth 0 to 3 points, with a maximum total score of 63. A score of 0-13 indicates no depression, 14-19 indicates mild depression, 20-28 indicates moderate depression, and 29 points and above indicates severe depression. The Turkish validity and reliability study of the scale was conducted by Hisli in 1989.
Time frame: Baseline (pre-intervention) and Week 8 (post-intervention)
The Pittsburgh Sleep Quality Scale
The Pittsburgh Sleep Quality Scale is a 19-item self-report scale that assesses participants' sleep quality and disturbances over a one-month period. It includes components such as subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, sleep medication use, and daytime dysfunction. Each component is scored on a scale of 0-3. The total score of the 7 components gives the overall scale score. The total score ranges from 0 to 21. A total score greater than 5 indicates poor sleep quality. The Turkish validity and reliability study of the scale was conducted by Ağargün et al. in 1996.
Time frame: Baseline (pre-intervention) and Week 8 (post-intervention)
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Halic University