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Mindfulness-Based Education For Women With Polycystic Ovary Syndrome

19 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

78

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Gonca Buran, Associate Professor
  • Telefoonnummer: +90 2242942481
  • E-mail: gburan@uludag.edu.tr

Studie Locaties

  • Turkije (Türkiye)
      • Bursa, Turkije (Türkiye)
        • Werving
        • Bursa Uludag University obstetrics and gynecology clinic

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Geen tussenkomst: Usual Care Control Group
Control Group

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Introductieformulier
Tijdsspanne: Tijdens registratie (eerste dag)
Deelnemers vullen een introductieformulier van vijf vragen in, waaronder vier sociodemografische vragen en een vraag over geboortevoorkeuren.
Tijdens registratie (eerste dag)
PCOS-Specific Quality of Life
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in PCOS-Specific Quality of Life
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Aydin Adnan Menderes University

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 juli 2026

Primaire voltooiing (Geschat)

1 september 2026

Studie voltooiing (Geschat)

1 december 2026

Studieregistratiedata

Eerst ingediend

17 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

17 juli 2026

Eerst geplaatst (Werkelijk)

21 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

19 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026/148/5

Plan Individuele Deelnemersgegevens (IPD)

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NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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