Psychosocial Effects of Mindfulness-Based Exercise in Postmenopausal Women
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-60
SponsorHalic University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Volunteering to participate in the study
Being in the early postmenopausal period (no more than 8 years have passed since menopause)
Having experienced natural menopause
Having had at least one pregnancy
Disqualifiers
History of trauma or illness that would prevent exercise
Having received hormone replacement therapy
Being involved in a different exercise program
Presence of a severe cardiopulmonary, orthopedic, or neurological disease
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness-Based Stress Reduction Training
Other interventionParticipants 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Mindfulness groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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)2
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)3
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)4
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)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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