Mindfulness Based Stress ReductionNCT06892509
The Effect of Mindfulness Practice on Quality of Life, Life Satisfaction, Sleep Quality and Mental Well-being Levels in Menopausal Women
A study testing mindfulness-based stress reduction program in people with Mindfulness Based Stress Reduction, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mindfulness Based Stress Reduction
- What is being tested?
- mindfulness-based stress reduction program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Mindfulness Based Stress Reduction
- Being tested
- mindfulness-based stress reduction program
- Keywords
- Mindfulness-based stress reduction programme, Menopause, Mental well-being, Sleep quality, Life satisfaction, Quality of life
- Medical subject headings
- Psychological Well-Being, Sleep Initiation and Maintenance Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness-based stress reduction programBehavioural
In this study, Mindfulness-Based Stress Reduction Programme will be applied to the women to be included in the experimental group as a nursing intervention. For this programme, the researchers participated in the Mindfulness-Based Stress Reduction Programme consisting of eight internationally validated modules consisting of eight sessions given by Tera Consultancy and completed the training. The certificates of the researchers are given in the appendices. The experimental group will receive a mindfulness-based stress reduction programme for a total of eight weeks, 2-1.5 hours per week. The mindfulness programme usually lasts eight weeks because it has been reported that this is an effective period of time to produce noticeable changes in brain structure, stress levels, emotional regulation and general well-being.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Mindfulness-based stress reduction programme will be implemented Receives: Behavioral: mindfulness-based stress reduction program |
| No Intervention | No intervention | Control group.The control group will not be treated for eight weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utian Quality of Life Scale
It consists of four sub-dimensions. These are emotional quality of life sub-dimension, sexual quality of life sub-dimension, occupational/work quality of life sub-dimension and health quality of life sub-dimension. Each item of the scale is in five-point Likert type and the statements are ranked from 1 to 5 according to their suitability for the person. In the scale statements, 'strongly disagree' is evaluated on a scale of 1, 'disagree' on a scale of 2, 'somewhat agree' on a scale of 3, 'agree' on a scale of 4, and 'strongly agree' on a scale of 5. The scale consists of straight and reverse question items. The 4th, 7th, 7th, 8th, 11th, 12th, 12th, 13th, 15th and 16th question items of the scale are straight, a
Measured: 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.
Riverside Satisfaction with Life Scale
In the scale consisting of a total of 6 questions, each question is scored from 1 to 7. The scale is a seven-point Likert type. In the scale statements, the expression 'strongly disagree' is evaluated over 1 point, 'moderately disagree' is evaluated over 2 points, 'slightly disagree' is evaluated over 3 points, 'neither agree nor disagree' is evaluated over 4 points, 'slightly agree' is evaluated over 5 points, 'moderately agree' is evaluated over 6 points, and 'strongly agree' is evaluated over 7 points. The scale is one dimensional. All items of the scale are positive, there is no reverse statement. Total scores ranged from 6 to 42, with higher scores indicating higher levels of life satisfaction.
Measured: 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.
Pittsburgh Sleep Quality Scale
The index consists of 24 questions in total and each question is scored from 0 to 3. In the index, there are five questions asked for clinical information that are not used in the scoring to be answered by the bed mate of the individuals. In the index consisting of seven components; subjective sleep quality, habitual sleep efficiency, time to fall asleep, sleep duration, sleep disturbance, sleep medication use and daytime dysfunction are evaluated. The sum of the scores obtained from the seven components gives the total score of PDQI and the total PDQI score can be a score between 0-21. The sleep quality of individuals with a PDQI total score of 5 points or less is considered as 'good',
Measured: 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.
Warwick - Edinburgh Mental Well-being Scale
This scale is a tool used to assess the mental well-being levels of individuals. The scale consists of 14 items and is 5-point Likert type. In the scale statements, 'never' is expressed as 1, 'rarely' as 2, 'sometimes' as 3, 'often' as 4 and 'always' as 5 points. Scale scores vary between 14 and 70 and there are no reverse items in the scale. There are no sub-dimensions in the scale. It is also stated that the increase in the scale scores is related to the increase in the mental well-being of the individuals.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start15 Mar 2025
- Primary completion1 Apr 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mindfulness Based Stress ReductionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agri Ibrahim Cecen University
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Principal investigator, Ebru SOLMAZ, Agri Ibrahim Cecen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892509
- Sponsor's protocol ID
- Atatürk Uni.
- Status last verified
- Sep 2025
- First submitted
- 13 Mar 2025
- Last updated
- 24 Sep 2025
- 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 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06892509
- Acronym / sponsor ID
- Atatürk Uni.
- Conditions
- Mindfulness Based Stress Reduction
- Keywords
- Mindfulness-based stress reduction programme, Menopause, Mental well-being, Sleep quality, Life satisfaction, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Agri Ibrahim Cecen UniversityUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 24 Mar 2025 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: mindfulness-based stress reduction programMindfulness-based stress reduction programme will be implemented |
| No Intervention | No intervention | –Control group.The control group will not be treated for eight weeks. |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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),
Key exclusion criteria (3 listed)
- 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.
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 programIn this study, Mindfulness-Based Stress Reduction Programme will be applied to the women to be included in the experimental group as a nursing intervention. For this programme, the researchers participated in the Mindfulness-Based Stress Reduction Programme consisting of eight internationally validated modules consisting of eight sessions given by Tera Consultancy and completed the training. The certificates of the researchers are given in the appendices. The experimental group will receive a mindfulness-based stress reduction programme for a total of eight weeks, 2-1.5 hours per week. The mindfulness programme usually lasts eight weeks because it has been reported that this is an effective period of time to produce noticeable changes in brain structure, stress levels, emotional regulation and general well-being. | Behavioural | Experimental |
Primary outcome
Utian Quality of Life Scale
Time frame: 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.
It consists of four sub-dimensions. These are emotional quality of life sub-dimension, sexual quality of life sub-dimension, occupational/work quality of life sub-dimension and health quality of life sub-dimension. Each item of the scale is in five-point Likert type and the statements are ranked from 1 to 5 according to their suitability for the person. In the scale statements, 'strongly disagree' is evaluated on a scale of 1, 'disagree' on a scale of 2, 'somewhat agree' on a scale of 3, 'agree' on a scale of 4, and 'strongly agree' on a scale of 5. The scale consists of straight and reverse question items. The 4th, 7th, 7th, 8th, 11th, 12th, 12th, 13th, 15th and 16th question items of the scale are straight, a
Riverside Satisfaction with Life Scale
Time frame: 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.
In the scale consisting of a total of 6 questions, each question is scored from 1 to 7. The scale is a seven-point Likert type. In the scale statements, the expression 'strongly disagree' is evaluated over 1 point, 'moderately disagree' is evaluated over 2 points, 'slightly disagree' is evaluated over 3 points, 'neither agree nor disagree' is evaluated over 4 points, 'slightly agree' is evaluated over 5 points, 'moderately agree' is evaluated over 6 points, and 'strongly agree' is evaluated over 7 points. The scale is one dimensional. All items of the scale are positive, there is no reverse statement. Total scores ranged from 6 to 42, with higher scores indicating higher levels of life satisfaction.
Pittsburgh Sleep Quality Scale
Time frame: 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.
The index consists of 24 questions in total and each question is scored from 0 to 3. In the index, there are five questions asked for clinical information that are not used in the scoring to be answered by the bed mate of the individuals. In the index consisting of seven components; subjective sleep quality, habitual sleep efficiency, time to fall asleep, sleep duration, sleep disturbance, sleep medication use and daytime dysfunction are evaluated. The sum of the scores obtained from the seven components gives the total score of PDQI and the total PDQI score can be a score between 0-21. The sleep quality of individuals with a PDQI total score of 5 points or less is considered as 'good',
Warwick - Edinburgh Mental Well-being Scale
Time frame: 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.
This scale is a tool used to assess the mental well-being levels of individuals. The scale consists of 14 items and is 5-point Likert type. In the scale statements, 'never' is expressed as 1, 'rarely' as 2, 'sometimes' as 3, 'often' as 4 and 'always' as 5 points. Scale scores vary between 14 and 70 and there are no reverse items in the scale. There are no sub-dimensions in the scale. It is also stated that the increase in the scale scores is related to the increase in the mental well-being of the individuals.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness-based stress reduction program in people with Mindfulness Based Stress Reduction, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utian Quality of Life Scale (time frame: 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.). 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 24 Sep 2025.