ClinicalTrials.gg
Active, not recruitingNCT07718217Updated Oct 27, 2026

Mindfulness-Based Education For Women With Polycystic Ovary Syndrome

An interventional study of Mindfulness-Based Polycystic Ovary Syndrome (PCOS) Education in Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms and Stress, sponsored by Aydin Adnan Menderes University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Aydin Adnan Menderes University · Not applicable, Interventional, and Supportive care

Updated Oct 27, 2026Now Active, not recruitingPrimary completion moved+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 72 studies in Polycystic Ovary Syndrome with a site in Turkey — 14 open to participants now, 15 under way, none of them phase 3. Polycystic Ovary Syndrome · Turkey.

Planned enrollment
10th of 29
78 · median 54
Started
2026
with 11 others
No phase
26 of 72
9 open now
Primary completion
2026-08
later than 6 of 14 live
Registered
65th of 72
by date

Among the 72 studies in Polycystic Ovary Syndrome with a site in Turkey, this one is the 10th largest by planned enrollment of the 29 interventional ones that give a count, is one of 12 that started in 2026, is one of 26 with no phase, reaches primary completion later than 6 of the 14 other live ones, and was the 65th registered.

Polycystic Ovary Syndrome

956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.

Browse Polycystic Ovary Syndrome studies →

Open to participants now

14 of the 72 studies in Polycystic Ovary Syndrome with a site in Turkey are open now. Recruiting first, the newest first:

9 more — sign in →

All 14 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 119 Polycystic Ovary Syndrome studies recruiting now, 11 (9%) set no upper age limit and 105 (88%) stop at 75 or younger; 23 take children under 18; 41 take healthy volunteers.

This study: 18 Years to 49 Years · female · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 72 studies in Polycystic Ovary Syndrome with a site in Turkey, or all of them as a file.
02

Study 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. 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.

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.

03

Conditions studied

  • Polycystic Ovary Syndrome (PCOS)
  • Menstrual Symptoms
  • Stress
  • Quality of Life

Keywords

  • Polycystic Ovary Syndrome
  • PCOS
  • Mindfulness-Based Education
  • Mindfulness
  • Menstrual Symptoms
  • Menstrual Pain
  • PCOS-Specific Quality of Life
  • Quality of Life
04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 before participation.

Exclusion criteria

Exclusion Criteria:

  • 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 at any stage of the study.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
78 participants (estimated)

Study arms

  • Experimental
    Mindfulness-Based Polycystic Ovary Syndrome Education

    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.

    Behavioral: Mindfulness-Based Polycystic Ovary Syndrome (PCOS) Education

  • No intervention
    Usual Care Control Group

    Control Group

Interventions

  • BehavioralMindfulness-Based Polycystic Ovary Syndrome (PCOS) Education

    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.

06

What researchers measure

Primary outcomes

  1. Introduction form

    Participants will complete a five-question introduction form, including four sociodemographic questions and a question about birth preferences.

    Time frame: During registration (first day)

  2. 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.

    Time frame: During registration (first day)

  3. 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.

    Time frame: Day 1 (During recruitment)

  4. 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.

    Time frame: Day 1 (During recruitment)

  5. 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).

    Time frame: Day 1 (during recruitment)

  6. 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.

    Time frame: immediately after the 4-week education program

  7. 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.

    Time frame: Immediately after the 4-week education program

  8. 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.

    Time frame: immediately after the 4-week education program

  9. 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.

    Time frame: immediately after the 4-week education program

Secondary outcomes

  1. 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.

    Time frame: at the 8-week follow-up.

  2. 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.

    Time frame: 8-week follow-up

  3. 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.

    Time frame: 8-week follow-up

  4. 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.

    Time frame: 8-week follow-up

07

Study locations

1 site
08

References and documents

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 37867573 ↗
  • Teede 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 37580314 ↗
  • Nasiri-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 26814480 ↗
  • Chesney 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 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2026 to primary completion in Aug 2026, 1 month.

Of 202 non-industry interventional studies with no phase under Polycystic Ovary Syndrome, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 39. This study's 1 month is below that.

Counting every sponsor, half of 217 studies reached it within 18 months; a quarter within 7 and three quarters within 39.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 27, 2026: primary completion Sep 2026 → Aug 2026 and completion Dec 2026 → Jan 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jul 17, 2026
First posted
Jul 21, 2026
StartActual
Jul 20, 2026
Primary completionActual
Aug 30, 2026was Sep 2026
CompletionEst.
Jan 30, 2027was Dec 2026
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Oct 27, 2026
Primary completion
Sep 2026→Aug 30, 2026 (actual)
Oct 27, 2026
Study completion
Dec 2026→Jan 30, 2027
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    Recruiting→Active, not recruiting
    Primary completion Sep 2026→Aug 30, 2026 (now actual)
    Study completion Dec 2026→Jan 30, 2027
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07718217
Responsible party
Gonca Buran (Associate Professor, Aydin Adnan Menderes University) — Principal investigator
First posted
Jul 21, 2026
Start date
Jul 20, 2026
Primary completion
Aug 30, 2026
Completion
Jan 30, 2027 (estimated)
Last update
Oct 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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