Postmenopausal PeriodMOPKANCT07034885
Effects of Mindfulness-Based Self-Efficacy Development Program on Postmenopausal Women
A study testing Mindfulness-Based Self-Efficacy Development Program in people with Postmenopausal Period and Menopausal Symptoms, run by Nurcan Gökgöz at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomized controlled clinical trial is to evaluate the effects of a mindfulness-based self-efficacy development program on menopausal symptoms and quality of life in postmenopausal women. Read more about this study
- Who is it for?
- Ages 45 to 57 years, women only
- Conditions the study is for
- Postmenopausal Period, Menopausal Symptoms, Quality of Life
- What is being tested?
- Mindfulness-Based Self-Efficacy Development Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 28 Feb 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 57 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Individuals who are in the +1a or +1b substage of early postmenopause according to the STRAW+10 system (at least 12 months and at most 24 months have passed since their last menstrual period)
- Are proficient in reading and writing Turkish
- Are in a spouse or partner
- Have entered menopause naturally
- Do not have a physical disability such as a severe musculoskeletal disorder, neurological disease, or mobility limitation that would prevent the use of mindfulness techniques (e.g., seated meditation, breathing exercises, gentle body awareness exercises)
- Have not used MBSR techniques in the last six months
- Own a smartphone or internet-enabled device.
Who cannot join
- Those who completed the pretest data collection forms incompletely,
- Those who had any psychological disorder or experienced a traumatic event in the last two to one years,
- Those who received hormone replacement therapy during menopause,
- Those who had any gynecological cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Lokman Hekim Univeristy
Ankara, Çankaya, 06510
Nurcan Gökgöz, PhD student, +90 312 444 8 548, nurcan.hilalay55@gmail.com
Didem Şimşek Küçükkelepçe, Assoc. Prof. Dr., +90 312 444 8 548, didemkucukkelepce@gmail.com
About this study
Official title: Effects of Mindfulness-Based Self-Efficacy Development Program on Menopausal Symptoms and Quality of Life in Postmenopausal Women: A Randomized Controlled Trial
The aim of this randomized controlled clinical trial is to evaluate the effects of a mindfulness-based self-efficacy development program on menopausal symptoms and quality of life in postmenopausal women. The main questions it aims to answer are:
Does the mindfulness-based program reduce the severity of menopausal symptoms?
Read more
Does the mindfulness-based program improve the quality of life of postmenopausal women?
Does the mindfulness-based program significantly increase participants' overall self-efficacy?
The researchers will compare whether there are differences between the mindfulness-based training program applied to the intervention group and the control group in terms of menopausal symptoms, quality of life, and self-efficacy scores.
The main tasks that will be asked of the participants are as follows:
Those in the intervention group will participate in a face-to-face mindfulness-based self-efficacy development program, each session lasting at least 120 minutes, once a week for 8 weeks, with a maximum of 10 people per group.
The control group will not receive any intervention.
Participants in both groups will be evaluated with a personal information form and measurement tools such as the Menopause Symptoms Assessment Scale, the Menopause Specific Quality of Life Scale, and the General Self-efficacy Scale.
Read the detailed description
This research is a randomized controlled experimental study aiming to evaluate the effects of a mindfulness-based self-efficacy development program on menopausal symptoms and quality of life in women during menopause. The research will be conducted at Lokman Hekim University Etlik Hospital between September 2025 and March 2026.
Postmenopausal women who have entered menopause naturally, who do not have a physical disability that prevents them from participating in mindfulness practices, who are literate and literate in Turkish, and who have access to technology will be included in the study. Participants will be assigned to the intervention and control groups by simple randomization.
Participants in the intervention group will receive an eight-week mindfulness-based self-efficacy development training based on Kabat-Zinn's Mindfulness-Based Stress Reduction (MBSR) program. Sessions will be held face-to-face once a week for 90-120 minutes. The program consists of components such as breath awareness, focusing on bodily sensations, mindful movement, working with emotions, and present-moment awareness.
Standard scales will be applied to all participants before and after the study to assess menopausal symptoms, quality of life and general self-efficacy levels. The collected data will be compared statistically.
This study aims to be an original study to evaluate whether a mindfulness-based self-efficacy development program has the potential to help control menopausal symptoms and improve quality of life in postmenopausal women.
- Conditions
- Postmenopausal Period, Menopausal Symptoms, Quality of Life, Stress Management, Self-Efficacy
- Being tested
- Mindfulness-Based Self-Efficacy Development Program
- Keywords
- Menopause, Self-Efficacy, Quality of Life, Mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Self-Efficacy Development ProgramBehavioural
"Mindfulness-Based Self-Efficacy Development Program" is a unique intervention model that integrates mindfulness-based practices with self-efficacy theory, structured for postmenopausal women. With the implementation of this research, a holistic and evidence-based intervention model will be presented for physical, psychological and social problems frequently encountered in the postmenopausal period. This program processes mindfulness-based skills such as observing thoughts, body awareness, regulating emotions, coping with stress and developing self-compassion in the axis of self-efficacy development with 8-week structured sessions. In this context, it is anticipated that the study will contribute to scientific knowledge and practices.
In addition, the "Mindfulness-Based Self-Efficacy Development Program" developed in the study aims not only at symptom management, but also at increasing the individual's perception of control over their own lives, recognizing their internal resources and
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | In the Mindfulness-Based Self-Efficacy Development Program, it is planned that the training groups will consist of a maximum of 10 people.
The trainings will be structured as 90-120 minute sessions, 1 day a week, for a total of 8 weeks. Each session will be carried out through face-to-face training.
The program content is structured based on Kabat-Zinn's Mindfulness-Based Stress Reduction (MBSR) protocol. The program focuses on breath awareness, focusing on bodily sensations, moving with awareness, eating with awareness and mindfulness in daily activities, coping with thoughts, emotions and stressful situations with awareness, and the present moment as a safe space within the framework of the basic components of self-compassion, intention and attitude.
Each session will include story content appropriate to the main theme of the session. The trainings applied to the intervention group were prepared within the scope of the "Mindfulness-Based Self-Efficacy Development Program" and the co Receives: Behavioral: Mindfulness-Based Self-Efficacy Development Program |
| Control Group | No intervention | The participants in the control group will be administered the measurement tools applied to the intervention group at the beginning of the study. At the end of the 8-week follow-up period, the same scales applied in the pre-test will be re-administered and interim test data will be collected. Thus, the level of change in the control group will be evaluated comparatively with the intervention group. Following the completion of the 4-week home practice applications of the intervention group, post-test data will be collected from the control group. No intervention will be applied to the participants in the control group during the study. However, in accordance with ethical principles, the content program of the sixth week of the eight-week mindfulness training applied to the intervention group will be presented to the women in the control group after the study is completed. In addition, training brochures shared with the intervention group will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in menopausal symptom severity
The severity of menopausal symptoms will be measured using the Menopausal Symptoms Rating Scale. The scale covers psychological, urogenital, and somatic dimensions. The Likert-type scale, consisting of 11 items covering menopausal complaints, includes options for each item: 0: None at all, 1: Mild, 2: Moderate, 3: Severe, and 4: Very severe. The total scale score is calculated based on the scores given for each item. The minimum possible score is 0, while the maximum is 44. A higher score indicates both an increase in the severity of menopausal symptoms and a negative impact on quality of life.
Measured: Pre-intervention, post-intervention (week 8), follow-up (week 12)
Change in quality of life
Quality of life will be assessed with the Menopause-Related Quality of Life Scale (MENQOL). The scale includes vasomotor, psychosomatic, psychological and sexual life subscales. As the scores increase, the severity of the problems experienced increases. Lower scores indicate higher quality of life.
On the MÖYKÖ-II, each subdomain score is ranked from 0 to 6. Women are asked to answer "no" or "yes" regarding any complaints they have experienced in the past month. If the answer is "yes," the participant scores each symptom on a scale of 0-6, indicating its presence. A "none" indicates that the symptom is not experienced, a "none" indicates that the symptom is present, and scores of 1-6 indicate the severity and increasing severity of the problem. The researcher scores each item on a scale of 1 to 8, including "none" and "none." The minimum score for each item is 1, and the maximum is 8. The minimum score for the total scale is 29, and the maximum is (29X8) 232.
Measured: Pre-intervention, post-intervention (8th week), follow-up (12th week)
Change in self-efficacy level
Women's self-efficacy perceptions will be measured using the General Self-Efficacy Scale (GSES). The GSES is a 17-item Likert-type scale with a minimum score of 17 and a maximum score of 85. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, and 17 are reverse-scored. Higher scores indicate higher self-efficacy beliefs. The scale consists of three subscales: initiation, perseverance, and persistence.
Measured: Pre-intervention, post-intervention (8th week), follow-up (12th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start15 Sep 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal PeriodStudies 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
- Model description
- This study is conducted with a randomized controlled, parallel group intervention model. Participants were divided into two groups, intervention and control groups, by simple randomization. The intervention group will be administered an 8-week Mindfulness-Based Self-Efficacy Development Program. The control group will not receive any intervention. Data from both groups will be collected with the same measurement tools before the program, at the end of the program (week 8), and 4 weeks after the end of the program.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nurcan Gökgöz
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Nurcan Gökgöz, Lokman Hekim University
- Investigators
- Didem Şimşek Küçükkelepçe, Assoc. Prof. Dr., Study director, Lokman Hekim University, Institute of Health Sciences, Department of Midwifery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034885
- Sponsor's protocol ID
- LokmanHekimU
- Acronym
- MOPKA
- Status last verified
- Jul 2025
- First submitted
- 14 Jun 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants' age, gender, education level, menopause process, self-efficacy scores, quality of life and symptom management data will be shared, with their identity confidential.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mindfulness-Based Self-Efficacy Development Program on Menopausal Symptoms and Quality of Life in Postmenopausal Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07034885
- Acronym / sponsor ID
- MOPKA / LokmanHekimU
- Conditions
- Postmenopausal Period, Menopausal Symptoms, Quality of Life, Stress Management, Self-Efficacy
- Keywords
- Menopause, Self-Efficacy, Quality of Life, Mindfulness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Nurcan GökgözOther government
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 24 Jun 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.
The aim of this randomized controlled clinical trial is to evaluate the effects of a mindfulness-based self-efficacy development program on menopausal symptoms and quality of life in postmenopausal women. The main questions it aims to answer are:
Does the mindfulness-based program reduce the severity of menopausal symptoms?
Does the mindfulness-based program improve the quality of life of postmenopausal women?
Does the mindfulness-based program significantly increase participants' overall self-efficacy?
The researchers will compare whether there are differences between the mindfulness-based training program applied to the intervention group and the control group in terms of menopausal symptoms, quality of life, and self-efficacy scores.
The main tasks that will be asked of the participants are as follows:
Those in the intervention group will participate in a face-to-face mindfulness-based self-efficacy development program, each session lasting at least 120 minutes, once a week for 8 weeks, with a maximum of 10 people per group.
The control group will not receive any intervention.
Participants in both groups will be evaluated with a personal information form and measurement tools such as the Menopause Symptoms Assessment Scale, the Menopause Specific Quality of Life Scale, and the General Self-efficacy Scale.
Detailed description
This research is a randomized controlled experimental study aiming to evaluate the effects of a mindfulness-based self-efficacy development program on menopausal symptoms and quality of life in women during menopause. The research will be conducted at Lokman Hekim University Etlik Hospital between September 2025 and March 2026.
Postmenopausal women who have entered menopause naturally, who do not have a physical disability that prevents them from participating in mindfulness practices, who are literate and literate in Turkish, and who have access to technology will be included in the study. Participants will be assigned to the intervention and control groups by simple randomization.
Participants in the intervention group will receive an eight-week mindfulness-based self-efficacy development training based on Kabat-Zinn's Mindfulness-Based Stress Reduction (MBSR) program. Sessions will be held face-to-face once a week for 90-120 minutes. The program consists of components such as breath awareness, focusing on bodily sensations, mindful movement, working with emotions, and present-moment awareness.
Standard scales will be applied to all participants before and after the study to assess menopausal symptoms, quality of life and general self-efficacy levels. The collected data will be compared statistically.
This study aims to be an original study to evaluate whether a mindfulness-based self-efficacy development program has the potential to help control menopausal symptoms and improve quality of life in postmenopausal women.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is conducted with a randomized controlled, parallel group intervention model. Participants were divided into two groups, intervention and control groups, by simple randomization. The intervention group will be administered an 8-week Mindfulness-Based Self-Efficacy Development Program. The control group will not receive any intervention. Data from both groups will be collected with the same measurement tools before the program, at the end of the program (week 8), and 4 weeks after the end of the program.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Mindfulness-Based Self-Efficacy Development ProgramIn the Mindfulness-Based Self-Efficacy Development Program, it is planned that the training groups will consist of a maximum of 10 people. The trainings will be structured as 90-120 minute sessions, 1 day a week, for a total of 8 weeks. Each session will be carried out through face-to-face training. The program content is structured based on Kabat-Zinn's Mindfulness-Based Stress Reduction (MBSR) protocol. The program focuses on breath awareness, focusing on bodily sensations, moving with awareness, eating with awareness and mindfulness in daily activities, coping with thoughts, emotions and stressful situations with awareness, and the present moment as a safe space within the framework of the basic components of self-compassion, intention and attitude. Each session will include story content appropriate to the main theme of the session. The trainings applied to the intervention group were prepared within the scope of the "Mindfulness-Based Self-Efficacy Development Program" and the co |
| Control Group | No intervention | –The participants in the control group will be administered the measurement tools applied to the intervention group at the beginning of the study. At the end of the 8-week follow-up period, the same scales applied in the pre-test will be re-administered and interim test data will be collected. Thus, the level of change in the control group will be evaluated comparatively with the intervention group. Following the completion of the 4-week home practice applications of the intervention group, post-test data will be collected from the control group. No intervention will be applied to the participants in the control group during the study. However, in accordance with ethical principles, the content program of the sixth week of the eight-week mindfulness training applied to the intervention group will be presented to the women in the control group after the study is completed. In addition, training brochures shared with the intervention group will be provided. |
Who may qualify
- Ages
- 45 to 57 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Individuals who are in the +1a or +1b substage of early postmenopause according to the STRAW+10 system (at least 12 months and at most 24 months have passed since their last menstrual period)
- Are proficient in reading and writing Turkish
- Are in a spouse or partner
- Have entered menopause naturally
- Do not have a physical disability such as a severe musculoskeletal disorder, neurological disease, or mobility limitation that would prevent the use of mindfulness techniques (e.g., seated meditation, breathing exercises, gentle body awareness exercises)
Key exclusion criteria (4 listed)
- Those who completed the pretest data collection forms incompletely,
- Those who had any psychological disorder or experienced a traumatic event in the last two to one years,
- Those who received hormone replacement therapy during menopause,
- Those who had any gynecological cancer
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 Self-Efficacy Development Program"Mindfulness-Based Self-Efficacy Development Program" is a unique intervention model that integrates mindfulness-based practices with self-efficacy theory, structured for postmenopausal women. With the implementation of this research, a holistic and evidence-based intervention model will be presented for physical, psychological and social problems frequently encountered in the postmenopausal period. This program processes mindfulness-based skills such as observing thoughts, body awareness, regulating emotions, coping with stress and developing self-compassion in the axis of self-efficacy development with 8-week structured sessions. In this context, it is anticipated that the study will contribute to scientific knowledge and practices. In addition, the "Mindfulness-Based Self-Efficacy Development Program" developed in the study aims not only at symptom management, but also at increasing the individual's perception of control over their own lives, recognizing their internal resources and | Behavioural | Intervention Group |
Primary outcome
Change in menopausal symptom severity
Time frame: Pre-intervention, post-intervention (week 8), follow-up (week 12)
The severity of menopausal symptoms will be measured using the Menopausal Symptoms Rating Scale. The scale covers psychological, urogenital, and somatic dimensions. The Likert-type scale, consisting of 11 items covering menopausal complaints, includes options for each item: 0: None at all, 1: Mild, 2: Moderate, 3: Severe, and 4: Very severe. The total scale score is calculated based on the scores given for each item. The minimum possible score is 0, while the maximum is 44. A higher score indicates both an increase in the severity of menopausal symptoms and a negative impact on quality of life.
Change in quality of life
Time frame: Pre-intervention, post-intervention (8th week), follow-up (12th week)
Quality of life will be assessed with the Menopause-Related Quality of Life Scale (MENQOL). The scale includes vasomotor, psychosomatic, psychological and sexual life subscales. As the scores increase, the severity of the problems experienced increases. Lower scores indicate higher quality of life. On the MÖYKÖ-II, each subdomain score is ranked from 0 to 6. Women are asked to answer "no" or "yes" regarding any complaints they have experienced in the past month. If the answer is "yes," the participant scores each symptom on a scale of 0-6, indicating its presence. A "none" indicates that the symptom is not experienced, a "none" indicates that the symptom is present, and scores of 1-6 indicate the severity and increasing severity of the problem. The researcher scores each item on a scale of 1 to 8, including "none" and "none." The minimum score for each item is 1, and the maximum is 8. The minimum score for the total scale is 29, and the maximum is (29X8) 232.
Change in self-efficacy level
Time frame: Pre-intervention, post-intervention (8th week), follow-up (12th week)
Women's self-efficacy perceptions will be measured using the General Self-Efficacy Scale (GSES). The GSES is a 17-item Likert-type scale with a minimum score of 17 and a maximum score of 85. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, and 17 are reverse-scored. Higher scores indicate higher self-efficacy beliefs. The scale consists of three subscales: initiation, perseverance, and persistence.
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 22 Jul 2025.
- Individual participant dataSharing planned: Yes. Participants' age, gender, education level, menopause process, self-efficacy scores, quality of life and symptom management data will be shared, with their identity confidential.
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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.
Didem Şimşek Küçükkelepçe, Assoc. Prof. Dr. study director
Lokman Hekim University, Institute of Health Sciences, Department of Midwifery
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 Self-Efficacy Development Program in people with Postmenopausal Period and Menopausal Symptoms, run by Nurcan Gökgöz 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 7 inclusion and 4 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 22 Jul 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?
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 Nurcan Gökgöz, PhD student (+90 312 444 8 548, nurcan.hilalay55@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in menopausal symptom severity (time frame: Pre-intervention, post-intervention (week 8), follow-up (week 12)). The study lists 3 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 22 Jul 2025.