Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Gonca Buran, Associate Professor
- Telefonnummer: +90 2242942481
- E-post: gburan@uludag.edu.tr
Studieorter
-
-
-
Bursa, Turkiet (Türkiye)
- Rekrytering
- Bursa Uludag University obstetrics and gynecology clinic
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
|
|
Inget ingripande: Usual Care Control Group
Control Group
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Introduktionsform
Tidsram: Under registrering (första dagen)
|
Deltagarna kommer att fylla i ett introduktionsformulär för fem frågor, inklusive fyra sociodemografiska frågor och en fråga om födelsepreferenser.
|
Under registrering (första dagen)
|
|
PCOS-Specific Quality of Life
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in PCOS-Specific Quality of Life
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Genitala sjukdomar
- Smärta
- Neurologiska manifestationer
- Sjukdomar i det endokrina systemet
- Patologiska processer
- Neoplasmer
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Genitala sjukdomar, kvinnor
- Ovariella sjukdomar
- Adnexala sjukdomar
- Gonadal sjukdomar
- Cystor på äggstockarna
- Cystor
- Bäckensmärta
- Menstruationsstörningar
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Polycystiskt ovariesyndrom
- Dysmenorré
- Socioekonomiska faktorer
- Befolkningsegenskaper
- Utbildningsstatus
Andra studie-ID-nummer
- 2026/148/5
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .