MINDFULNESS-BASED EDUCATION FOR WOMEN WITH POLYCYSTIC OVARY SYNDROME

NCT07718217 | Not Yet Recruiting

• 1 other identifier: 2026/148/5
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (9)

• Introduction form

  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

  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

  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

  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

  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

  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)

  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

  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

  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 Outcomes (4)

• Change in PCOS-Specific Quality of Life

  at the 8-week follow-up.

• Change in Perceived Stress

  8-week follow-up

• Change in Menstrual Symptoms

  8-week follow-up

• Change in Menstrual Pain Severity

  8-week follow-up

Study Arms (2)

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.

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

Usual Care Control Group

NO INTERVENTION

Control Group

Interventions

Mindfulness-Based Polycystic Ovary Syndrome (PCOS) Education BEHAVIORAL

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.

Mindfulness-Based Polycystic Ovary Syndrome Education

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: The study is limited to individuals who self-identify as female, are of reproductive age, and have a confirmed diagnosis of Polycystic Ovary Syndrome (PCOS) according to the study eligibility criteria.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Related Publications (4)

• 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.

  PMID: 37867573 RESULT

• 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.

  PMID: 37580314 RESULT

• 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.

  PMID: 26814480 RESULT

• 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.

  PMID: 1238078 RESULT

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Dysmenorrhea

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Central Study Contacts

Gonca Buran, Associate Professor

CONTACT

+90 2242942481; gburan@uludag.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study is open-label for participants, care providers, and investigators involved in the intervention process, given the nature of the educational intervention. The outcomes assessor will be blinded to participants' group allocation to reduce bias in the assessment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 21, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share