Psychosocial FunctioningNCT07424521
Psychosocial Effects of Mindfulness-Based Exercise in Postmenopausal Women
A study testing Mindfulness-Based Stress Reduction Training in people with Psychosocial Functioning and Mindfulness, run by Halic University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Psychosocial Functioning, Mindfulness, Postmenopausal Symptoms
- What is being tested?
- Mindfulness-Based Stress Reduction Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- Residing in Istanbul or Izmir provinces
Who cannot join
- 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
- Presence of a psychological or psychiatric diagnosis
- Presence of physical discomforts such as severe dizziness
- Cooperation problems and incompatibility
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
İrem Çetinkaya, PhD contact
About this study
Official title: The Effects of Mindfulness-Based Exercise on Anxiety, Depression, and Sleep Quality in Postmenopausal Women
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.
Read the detailed description
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.
- Being tested
- Mindfulness-Based Stress Reduction Training
- Keywords
- mindfulness, postmenopausal, depression, sleep quality, anxiety
- Medical subject headings
- Depression, Sleep Initiation and Maintenance Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress Reduction TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness group | Experimental | This represents the group that will receive mindfulness-based training for 8 weeks. Receives: Other: Mindfulness-Based Stress Reduction Training |
| Control group | No intervention | This represents the control group, where no intervention is applied, as is the case in routine training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (pre-intervention) and Week 8 (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosocial FunctioningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İrem Çetinkaya, Halic University
- Investigators
- İrem Çetinkaya, PhD, Principal investigator, Haliç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424521
- Sponsor's protocol ID
- karanki6
- Status last verified
- Feb 2026
- First submitted
- 14 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mindfulness-Based Exercise on Anxiety, Depression, and Sleep Quality in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT07424521
- Acronym / sponsor ID
- karanki6
- Keywords
- mindfulness, postmenopausal, depression, sleep quality, anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Mindfulness group | Experimental | Other: Mindfulness-Based Stress Reduction TrainingThis represents the group that will receive mindfulness-based training for 8 weeks. |
| Control group | No intervention | –This represents the control group, where no intervention is applied, as is the case in routine training. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
- Residing in Istanbul or Izmir provinces
Key exclusion criteria (7 listed)
- 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
- Presence of a psychological or psychiatric diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Stress Reduction TrainingParticipants 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. | Other | Mindfulness group |
Primary outcome
The STAI I-II State and Trait Anxiety Scale
Time frame: Baseline (pre-intervention) and Week 8 (post-intervention)
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.
Beck Anxiety Inventory
Time frame: Baseline (pre-intervention) and Week 8 (post-intervention)
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.
Beck Depression Inventory
Time frame: Baseline (pre-intervention) and Week 8 (post-intervention)
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.
The Pittsburgh Sleep Quality Scale
Time frame: Baseline (pre-intervention) and Week 8 (post-intervention)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
İrem Çetinkaya, PhD contact
İrem Çetinkaya, PhD principal investigator
Haliç University
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction Training in people with Psychosocial Functioning and Mindfulness, run by Halic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İrem Çetinkaya, PhD (iremkaranki@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The STAI I-II State and Trait Anxiety Scale (time frame: Baseline (pre-intervention) and Week 8 (post-intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.