Mindfulness-Based Education For Women With Polycystic Ovary Syndrome

August 19, 2026 updated by: Gonca Buran, Aydin Adnan Menderes University

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
      • Bursa, Turkey (Türkiye)
        • Recruiting
        • Bursa Uludag University obstetrics and gynecology clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 informed consent before participation.

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 informed consent at any stage of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
No Intervention: Usual Care Control Group
Control Group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
During registration (first day)
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.
During registration (first day)
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.
Day 1 (During recruitment)
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.
Day 1 (During recruitment)
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).
Day 1 (during recruitment)
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 the 4-week education program
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.
Immediately after the 4-week education program
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.
immediately after the 4-week education program
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.
immediately after the 4-week education program

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in PCOS-Specific Quality of Life
Time Frame: at the 8-week follow-up.
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.
at the 8-week follow-up.
Change in Perceived Stress
Time Frame: 8-week follow-up
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.
8-week follow-up
Change in Menstrual Symptoms
Time Frame: 8-week follow-up
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.
8-week follow-up
Change in Menstrual Pain Severity
Time Frame: 8-week follow-up
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.
8-week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aydin Adnan Menderes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026/148/5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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