Polycystic Ovary Syndrome (PCOS)NCT07718217
Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
A study testing Mindfulness-Based Polycystic Ovary Syndrome (PCOS) Education in people with Polycystic Ovary Syndrome (PCOS) and Menstrual Symptoms, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
Polycystic ovary syndrome (PCOS), also known as polyendocrine metabolic ovarian syndrome (PMOS), is the most common endocrinologic disorder to affect women. Despite this, the disease's pathophysiology remains unclear. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms, Stress
- What is being tested?
- Mindfulness-Based Polycystic Ovary Syndrome (PCOS) Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2026to 30 Jan 2027
- 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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Self-identify as female.
- Be of reproductive age (18-49 years).
- Have a confirmed diagnosis of Polycystic Ovary Syndrome (PCOS) based on the Rotterdam criteria.
- Be able to read, understand, and communicate in Turkish.
- Have access to the internet and a device capable of participating in online education sessions.
- Be willing to attend the four-week online education program and complete all study assessments.
- Provide written informed consent before participation.
Who cannot join
- Currently pregnant or breastfeeding.
- Having a severe psychiatric disorder or cognitive impairment that may interfere with participation.
- Having a serious chronic medical condition that could affect study outcomes or prevent participation in the intervention.
- Currently participating in another interventional research study.
- Having previously received structured mindfulness training or participated in a mindfulness-based program during the study period.
- Being unable to attend the online education sessions or complete the study assessments.
- Declining or withdrawing informed consent at any stage of the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Uludag University obstetrics and gynecology clinic
Bursa
About this study
Official title: The Effect Of Mindfulness-Based Education For Women With Polycystic Ovary Syndrome On Menstrual Symptoms, Stress, And Quality of Life: A Randomized Controlled Study
Polycystic ovary syndrome (PCOS), also known as polyendocrine metabolic ovarian syndrome (PMOS), is the most common endocrinologic disorder to affect women. Despite this, the disease's pathophysiology remains unclear. This has hindered the diagnosis of the disease and the appropriate treatment for millions of individuals. The long-term health sequelae associated with PCOS, future directions, and areas of needed research in this often-overlooked disease. Women with PCOS may experience menstrual symptoms, increased stress, and difficulties in managing the physical and emotional effects of the condition. Supportive approaches that improve symptom management and quality of life may be beneficial in addition to routine care.
The aim of this randomized controlled study is to evaluate the effect of mindfulness-based PCOS education on menstrual symptoms, stress levels, and quality of life in women with PCOS. The study will examine whether a structured mindfulness-based education program can support women in managing PCOS-related symptoms and improving their overall well-being.
Read more
Women diagnosed with PCOS who meet the study eligibility criteria will be invited to participate. Participants will be randomly assigned to either the intervention group or the control group. Participants in the intervention group will receive a mindfulness-based PCOS education program, while those in the control group will receive routine care without it.
Researchers will assess participants' menstrual symptoms, stress levels, and quality of life using validated measurement tools before and after the intervention. The findings of this study will provide information about the potential role of mindfulness-based education as a supportive approach in the management of PCOS and may contribute to the development of patient-centered education programs for women with PCOS.
Read the detailed description
Polikistik Over Sendromu (PCOS), üreme çağındaki kadınları etkileyen yaygın bir endokrinolojik rahatsızlıktır.is characterized by hormonal imbalance, ovulatory dysfunction, and clinical symptoms that may negatively affect reproductive health, psychological well-being, and quality of life. The effects of PCOS extend beyond reproductive symptoms, as women with PCOS may experience increased stress, emotionyaşayabilirs, and challenges in daily functioning.
Current guidelines recommend a comprehensive approach to PCOS management that addresses not only physical symptoms but also psychological well-being and quality of life. Menstrual symptoms and stress are important factors that may influence the overall health status of women with PCOS. Therefore, supportive approaches that enance self-management skills and promote psychological well-being may play an important role in improving outcomes in PCOS.
Mindfulness-based interventions are structured approaches that aim to improve awareness of thoughts, emotions, and bodily experiences through practices of attention and acceptance. Previous studies have shown that mindfulness-based programs may support stress management and psychological ell-being in different populations. However, evidence regarding mindfulness-based education specifically designed for women with PCOS remains limited.
This randomized controlled study aims to evaluate the effect of mindfulness-based PCOS education on menstrual symptoms, stress levels, and PCOS-related quality of life in women with PCOS. The study will investigate whether integrating mindfulness practices into a structured PCOS education program provides additional benefits compared with routine care.
A total of 78 women with PCOS will participate in the study. Participants will be randomly assigned to either the mindfulness-based PCOS educatin group or the control group. The intervention group will receive a 4-week online education program that includes PCOS-related health information, lifestyle managemet, and mindfulness-based practices. The control group will continue their usual care during the study period. Participant characteristics and clinical information will be collected using a researcher-developed Introductory Information Form. Study outcomes will be assessed using the Visual Analog Scale (VAS) for menstrual pain severity, the Menstruation Symptom Scale for menstrual symptoms, the Perceived Stress Scale (PSS-10) for perceived stress levels, and the PCOS-Specific Quality of Life Questionnaire (PCOSQ-50) for disease-specific quality of life.
The study is designed to provide evidence on the effectiveness oilişkinndfulness-based education as a supportive, patient-centered approach to PCOS management. The findings may contribute to the development of comprehensive education programs that address both physical symptoms and psychosocial needs of women with PCOS.
- Being tested
- Mindfulness-Based Polycystic Ovary Syndrome (PCOS) Education
- Keywords
- Polycystic Ovary Syndrome, PCOS, Mindfulness-Based Education, Mindfulness, Menstrual Symptoms, Menstrual Pain, PCOS-Specific Quality of Life, Quality of Life
- Medical subject headings
- Polycystic Ovary Syndrome, Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Polycystic Ovary Syndrome (PCOS) EducationBehavioural
A four-week online mindfulness-based Polycystic Ovary Syndrome (PCOS) education program will be provided to participants in the experimental group. The program will consist of weekly sessions lasting approximately 90 minutes and will include PCOS-related information, symptom management, lifestyle approaches, and mindfulness-based practices. Participants will also receive telephone-based support for questions and guidance related to the education program throughout the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Polycystic Ovary Syndrome Education | Experimental | Participants in this arm will receive a four-week online mindfulness-based Polycystic Ovary Syndrome (PCOS) education program. The program will include weekly sessions lasting approximately 90 minutes that cover PCOS-related information, symptom management, lifestyle approaches, and mindfulness-based practices. Participants will also receive telephone-based support for questions and guidance related to the education program during the intervention period. Receives: Behavioral: Mindfulness-Based Polycystic Ovary Syndrome (PCOS) Education |
| Usual Care Control Group | No intervention | Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introduction form
Participants will complete a five-question introduction form, including four sociodemographic questions and a question about birth preferences.
Measured: During registration (first day)
PCOS-Specific Quality of Life
PCOS-specific quality of life will be assessed using the Polycystic Ovary Syndrome Quality of Life Questionnaire (PCOSQ-50) before the education program. Baseline quality-of-life scores will be used to describe participants' initial status and to compare baseline characteristics between the intervention and control groups.
Measured: During registration (first day)
Menstrual Symptoms
Women's current menstrual symptoms will be assessed using the Menstrual Symptom Scale during enrollment prior to the awareness-based Polycystic Ovary Syndrome (PCOS) education. Baseline symptom scores will be compared between the intervention and control groups throughout the study time points.
Measured: Day 1 (During recruitment)
Perceived Stress
Baseline perceived stress levels of participants will be assessed using the Perceived Stress Scale (PSS-10) before the education program. Baseline stress levels will be evaluated to describe participants' initial status and compare baseline characteristics between the intervention and control groups.
Measured: Day 1 (During recruitment)
Menstrual Pain Severity
Women's current menstrual pain severity will be evaluated using the Visual Analog Scale (VAS) before intervention. Participants will rate their menstrual pain intensity on a 10-cm scale ranging from 0 (no pain) to 10 (worst possible pain).
Measured: Day 1 (during recruitment)
After intervention Menstrual Symptoms
The effect of mindfulness-based Polycystic Ovary Syndrome (PCOS) education on menstrual symptoms will be evaluated using the Menstruation Symptom Scale. Changes in menstrual symptom scores from baseline will be compared between the intervention and control groups across the study time points.
Measured: immediately after the 4-week education program
Immediately after intervention, PCOS-Specific Quality of Life (PCOSQ-50)
The effect of mindfulness-based Polycystic Ovary Syndrome (PCOS) education on PCOS-specific quality of life will be evaluated using the Polycystic Ovary Syndrome Quality of Life Questionnaire (PCOSQ-50). Changes in quality-of-life scores from baseline will be compared between the intervention and control groups.
Measured: Immediately after the 4-week education program
After intervention Perceived Stress
The effect of mindfulness-based education on Polycystic Ovary Syndrome (PCOS) on perceived stress levels will be evaluated using the Perceived Stress Scale (PSS-10). Changes in perceived stress scores from baseline will be compared between the intervention and control groups at each study time point.
Measured: immediately after the 4-week education program
After intervention Menstrual Pain Severity
The effect of mindfulness-based Polycystic Ovary Syndrome (PCOS) education on menstrual pain severity will be evaluated using the Visual Analog Scale (VAS). Participants will rate their menstrual pain intensity on a 10-cm scale ranging from 0 (no pain) to 10 (worst possible pain). Changes in menstrual pain severity scores from baseline will be compared between the intervention and control groups at each study time point.
Measured: immediately after the 4-week education program
Secondary outcomes (4)
Change in PCOS-Specific Quality of Life
Chances PCOS-specific quality of life will be assessed using the Polycystic Ovary Syndrome Quality of Life Questionnaire (PCOSQ-50). Changes in quality-of-life scores will be compared between the intervention and control groups at the 8-week follow-up.
Measured: at the 8-week follow-up.
Change in Perceived Stress
The effect of mindfulness-based education on Polycystic Ovary Syndrome (PCOS) on perceived stress levels will be evaluated using the Perceived Stress Scale (PSS-10). Changes in perceived stress scores will be compared between the intervention and control groups at each study time point.
Measured: 8-week follow-up
Change in Menstrual Symptoms
The effect of mindfulness-based Polycystic Ovary Syndrome (PCOS) education on menstrual symptoms will be evaluated using the Menstruation Symptom Scale. Changes in menstrual symptom scores will be compared between the intervention and control groups at each study time point.
Measured: 8-week follow-up
Change in Menstrual Pain Severity
The effect of mindfulness-based Polycystic Ovary Syndrome (PCOS) education on menstrual pain severity will be evaluated using the Visual Analog Scale (VAS). Participants will rate their menstrual pain intensity on a 10-cm scale ranging from 0 (no pain) to 10 (worst possible pain). Changes in pain severity scores will be compared between the intervention and control groups.
Measured: 8-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start20 Jul 2026
- Primary completion30 Aug 2026
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- Participants will be randomly assigned to one of two parallel groups: a mindfulness-based Polycystic Ovary Syndrome (PCOS) education intervention group or a control group. Participants in the intervention group will receive a 4-week online mindfulness-based PCOS education program comprising weekly sessions lasting approximately 90 minutes each. The education program will include mindfulness-based practices, PCOS-related health information, and symptom management strategies. Participants will also receive telephone-based support for questions and guidance related to the education program throughout the intervention period. Participants in the control group will continue their usual care. Outcomes will be assessed at baseline, after the intervention period, and at follow-up.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonca Buran, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718217
- Sponsor's protocol ID
- 2026/148/5
- Status last verified
- Oct 2026
- First submitted
- 17 Jul 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Galante J, Friedrich C; Collaboration of Mindfulness Trials (CoMinT) 3; Dalgleish T, Jones PB, White IR; Collaboration of Mindfulness Trials (CoMinT). Individual participant data systematic review and meta-analysis of randomised controlled trials assessing adult mindfulness-based programmes for mental health promotion in non-clinical settings. Nat Ment Health. 2023 Jul 10;1(7):462-476. doi: 10.1038/s44220-023-00081-5.
PubMed 37867573Teede HJ, Tay CT, Laven JJE, Dokras A, Moran LJ, Piltonen TT, Costello MF, Boivin J, Redman LM, Boyle JA, Norman RJ, Mousa A, Joham AE. Recommendations From the 2023 International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2023 Sep 18;108(10):2447-2469. doi: 10.1210/clinem/dgad463.
PubMed 37580314Nasiri-Amiri F, Ramezani Tehrani F, Simbar M, Montazeri A, Mohammadpour RA. Health-related quality of life questionnaire for polycystic ovary syndrome (PCOSQ-50): development and psychometric properties. Qual Life Res. 2016 Jul;25(7):1791-801. doi: 10.1007/s11136-016-1232-7. Epub 2016 Jan 27.
PubMed 26814480Chesney MA, Tasto DL. The development of the menstrual symptom questionnaire. Behav Res Ther. 1975 Oct;13(4):237-44. doi: 10.1016/0005-7967(75)90028-5. No abstract available.
PubMed 1238078
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Mindfulness-Based Education For Women With Polycystic Ovary Syndrome On Menstrual Symptoms, Stress, And Quality of Life: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07718217
- Acronym / sponsor ID
- 2026/148/5
- Keywords
- Polycystic Ovary Syndrome, PCOS, Mindfulness-Based Education, Mindfulness, Menstrual Symptoms, Menstrual Pain, PCOS-Specific Quality of Life, Quality of Life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 21 Jul 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.
Polycystic ovary syndrome (PCOS), also known as polyendocrine metabolic ovarian syndrome (PMOS), is the most common endocrinologic disorder to affect women. Despite this, the disease's pathophysiology remains unclear. This has hindered the diagnosis of the disease and the appropriate treatment for millions of individuals. The long-term health sequelae associated with PCOS, future directions, and areas of needed research in this often-overlooked disease. Women with PCOS may experience menstrual symptoms, increased stress, and difficulties in managing the physical and emotional effects of the condition. Supportive approaches that improve symptom management and quality of life may be beneficial in addition to routine care.
The aim of this randomized controlled study is to evaluate the effect of mindfulness-based PCOS education on menstrual symptoms, stress levels, and quality of life in women with PCOS. The study will examine whether a structured mindfulness-based education program can support women in managing PCOS-related symptoms and improving their overall well-being.
Women diagnosed with PCOS who meet the study eligibility criteria will be invited to participate. Participants will be randomly assigned to either the intervention group or the control group. Participants in the intervention group will receive a mindfulness-based PCOS education program, while those in the control group will receive routine care without it.
Researchers will assess participants' menstrual symptoms, stress levels, and quality of life using validated measurement tools before and after the intervention. The findings of this study will provide information about the potential role of mindfulness-based education as a supportive approach in the management of PCOS and may contribute to the development of patient-centered education programs for women with PCOS.
Detailed description
Polikistik Over Sendromu (PCOS), üreme çağındaki kadınları etkileyen yaygın bir endokrinolojik rahatsızlıktır.is characterized by hormonal imbalance, ovulatory dysfunction, and clinical symptoms that may negatively affect reproductive health, psychological well-being, and quality of life. The effects of PCOS extend beyond reproductive symptoms, as women with PCOS may experience increased stress, emotionyaşayabilirs, and challenges in daily functioning.
Current guidelines recommend a comprehensive approach to PCOS management that addresses not only physical symptoms but also psychological well-being and quality of life. Menstrual symptoms and stress are important factors that may influence the overall health status of women with PCOS. Therefore, supportive approaches that enance self-management skills and promote psychological well-being may play an important role in improving outcomes in PCOS.
Mindfulness-based interventions are structured approaches that aim to improve awareness of thoughts, emotions, and bodily experiences through practices of attention and acceptance. Previous studies have shown that mindfulness-based programs may support stress management and psychological ell-being in different populations. However, evidence regarding mindfulness-based education specifically designed for women with PCOS remains limited.
This randomized controlled study aims to evaluate the effect of mindfulness-based PCOS education on menstrual symptoms, stress levels, and PCOS-related quality of life in women with PCOS. The study will investigate whether integrating mindfulness practices into a structured PCOS education program provides additional benefits compared with routine care.
A total of 78 women with PCOS will participate in the study. Participants will be randomly assigned to either the mindfulness-based PCOS educatin group or the control group. The intervention group will receive a 4-week online education program that includes PCOS-related health information, lifestyle managemet, and mindfulness-based practices. The control group will continue their usual care during the study period. Participant characteristics and clinical information will be collected using a researcher-developed Introductory Information Form. Study outcomes will be assessed using the Visual Analog Scale (VAS) for menstrual pain severity, the Menstruation Symptom Scale for menstrual symptoms, the Perceived Stress Scale (PSS-10) for perceived stress levels, and the PCOS-Specific Quality of Life Questionnaire (PCOSQ-50) for disease-specific quality of life.
The study is designed to provide evidence on the effectiveness oilişkinndfulness-based education as a supportive, patient-centered approach to PCOS management. The findings may contribute to the development of comprehensive education programs that address both physical symptoms and psychosocial needs of women with PCOS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups: a mindfulness-based Polycystic Ovary Syndrome (PCOS) education intervention group or a control group. Participants in the intervention group will receive a 4-week online mindfulness-based PCOS education program comprising weekly sessions lasting approximately 90 minutes each. The education program will include mindfulness-based practices, PCOS-related health information, and symptom management strategies. Participants will also receive telephone-based support for questions and guidance related to the education program throughout the intervention period. Participants in the control group will continue their usual care. Outcomes will be assessed at baseline, after the intervention period, and at follow-up.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Polycystic Ovary Syndrome Education | Experimental | Behavioral: Mindfulness-Based Polycystic Ovary Syndrome (PCOS) EducationParticipants in this arm will receive a four-week online mindfulness-based Polycystic Ovary Syndrome (PCOS) education program. The program will include weekly sessions lasting approximately 90 minutes that cover PCOS-related information, symptom management, lifestyle approaches, and mindfulness-based practices. Participants will also receive telephone-based support for questions and guidance related to the education program during the intervention period. |
| Usual Care Control Group | No intervention | –Control Group |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Self-identify as female.
- Be of reproductive age (18-49 years).
- Have a confirmed diagnosis of Polycystic Ovary Syndrome (PCOS) based on the Rotterdam criteria.
- Be able to read, understand, and communicate in Turkish.
- Have access to the internet and a device capable of participating in online education sessions.
Key exclusion criteria (7 listed)
- Currently pregnant or breastfeeding.
- Having a severe psychiatric disorder or cognitive impairment that may interfere with participation.
- Having a serious chronic medical condition that could affect study outcomes or prevent participation in the intervention.
- Currently participating in another interventional research study.
- Having previously received structured mindfulness training or participated in a mindfulness-based program during the study period.
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 Polycystic Ovary Syndrome (PCOS) EducationA four-week online mindfulness-based Polycystic Ovary Syndrome (PCOS) education program will be provided to participants in the experimental group. The program will consist of weekly sessions lasting approximately 90 minutes and will include PCOS-related information, symptom management, lifestyle approaches, and mindfulness-based practices. Participants will also receive telephone-based support for questions and guidance related to the education program throughout the intervention period. | Behavioural | Mindfulness-Based Polycystic Ovary Syndrome Education |
Primary outcome
Introduction form
Time frame: During registration (first day)
Participants will complete a five-question introduction form, including four sociodemographic questions and a question about birth preferences.
PCOS-Specific Quality of Life
Time frame: During registration (first day)
PCOS-specific quality of life will be assessed using the Polycystic Ovary Syndrome Quality of Life Questionnaire (PCOSQ-50) before the education program. Baseline quality-of-life scores will be used to describe participants' initial status and to compare baseline characteristics between the intervention and control groups.
Menstrual Symptoms
Time frame: Day 1 (During recruitment)
Women's current menstrual symptoms will be assessed using the Menstrual Symptom Scale during enrollment prior to the awareness-based Polycystic Ovary Syndrome (PCOS) education. Baseline symptom scores will be compared between the intervention and control groups throughout the study time points.
Perceived Stress
Time frame: Day 1 (During recruitment)
Baseline perceived stress levels of participants will be assessed using the Perceived Stress Scale (PSS-10) before the education program. Baseline stress levels will be evaluated to describe participants' initial status and compare baseline characteristics between the intervention and control groups.
Menstrual Pain Severity
Time frame: Day 1 (during recruitment)
Women's current menstrual pain severity will be evaluated using the Visual Analog Scale (VAS) before intervention. Participants will rate their menstrual pain intensity on a 10-cm scale ranging from 0 (no pain) to 10 (worst possible pain).
After intervention Menstrual Symptoms
Time frame: immediately after the 4-week education program
The effect of mindfulness-based Polycystic Ovary Syndrome (PCOS) education on menstrual symptoms will be evaluated using the Menstruation Symptom Scale. Changes in menstrual symptom scores from baseline will be compared between the intervention and control groups across the study time points.
Immediately after intervention, PCOS-Specific Quality of Life (PCOSQ-50)
Time frame: Immediately after the 4-week education program
The effect of mindfulness-based Polycystic Ovary Syndrome (PCOS) education on PCOS-specific quality of life will be evaluated using the Polycystic Ovary Syndrome Quality of Life Questionnaire (PCOSQ-50). Changes in quality-of-life scores from baseline will be compared between the intervention and control groups.
After intervention Perceived Stress
Time frame: immediately after the 4-week education program
The effect of mindfulness-based education on Polycystic Ovary Syndrome (PCOS) on perceived stress levels will be evaluated using the Perceived Stress Scale (PSS-10). Changes in perceived stress scores from baseline will be compared between the intervention and control groups at each study time point.
After intervention Menstrual Pain Severity
Time frame: immediately after the 4-week education program
The effect of mindfulness-based Polycystic Ovary Syndrome (PCOS) education on menstrual pain severity will be evaluated using the Visual Analog Scale (VAS). Participants will rate their menstrual pain intensity on a 10-cm scale ranging from 0 (no pain) to 10 (worst possible pain). Changes in menstrual pain severity scores from baseline will be compared between the intervention and control groups at each study time point.
4 secondary outcomes
Change in PCOS-Specific Quality of Life
Time frame: at the 8-week follow-up.
Change in Perceived Stress
Time frame: 8-week follow-up
Change in Menstrual Symptoms
Time frame: 8-week follow-up
Change in Menstrual Pain Severity
Time frame: 8-week follow-up
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 27 Oct 2026.
- Results publication: PubMed 37867573Galante J, Friedrich C; Collaboration of Mindfulness Trials (CoMinT) 3; Dalgleish T, Jones PB, White IR; Collaboration of Mindfulness Trials (CoMinT). Individual participant data systematic review and meta-analysis of randomised controlled trials assessing adult mindfulness-based programmes for mental health promotion in non-clinical settings. Nat Ment Health. 2023 Jul 10;1(7):462-476. doi: 10.1038/s44220-023-00081-5.
- Results publication: PubMed 37580314Teede HJ, Tay CT, Laven JJE, Dokras A, Moran LJ, Piltonen TT, Costello MF, Boivin J, Redman LM, Boyle JA, Norman RJ, Mousa A, Joham AE. Recommendations From the 2023 International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2023 Sep 18;108(10):2447-2469. doi: 10.1210/clinem/dgad463.
- Results publication: PubMed 26814480Nasiri-Amiri F, Ramezani Tehrani F, Simbar M, Montazeri A, Mohammadpour RA. Health-related quality of life questionnaire for polycystic ovary syndrome (PCOSQ-50): development and psychometric properties. Qual Life Res. 2016 Jul;25(7):1791-801. doi: 10.1007/s11136-016-1232-7. Epub 2016 Jan 27.
- Results publication: PubMed 1238078Chesney MA, Tasto DL. The development of the menstrual symptom questionnaire. Behav Res Ther. 1975 Oct;13(4):237-44. doi: 10.1016/0005-7967(75)90028-5. No abstract available.
- 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 Polycystic Ovary Syndrome (PCOS) Education in people with Polycystic Ovary Syndrome (PCOS) and Menstrual Symptoms, run by Aydin Adnan Menderes 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 7 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. 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?
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?
Introduction form (time frame: During registration (first day)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07718217, which also lists 4 linked publications.
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 27 Oct 2026.