MINDFULNESS-BASED EDUCATION FOR WOMEN WITH POLYCYSTIC OVARY SYNDROME

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Introduction form [Time frame: During registration (first day)]
• PCOS-Specific Quality of Life [Time frame: During registration (first day)]
• Menstrual Symptoms [Time frame: Day 1 (During recruitment)]
• Perceived Stress [Time frame: Day 1 (During recruitment)]
• Menstrual Pain Severity [Time frame: Day 1 (during recruitment)]
• After intervention Menstrual Symptoms [Time frame: 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]
• After intervention Perceived Stress [Time frame: immediately after the 4-week education program]
• After intervention Menstrual Pain Severity [Time frame: immediately after the 4-week education program]

Secondary outcome measures (4)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

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: 10.103 PMID 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. PMID 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. PMID 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. PMID 1238078

Identifiers

NCT: NCT07718217 · 2026/148/5

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗