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Diaphragmatic Breathing Exercises on Sleep Disorders un Polycystic Ovarian Syndrome

12 juli 2026 bijgewerkt door: Adly A Adam

Effect of Diaphragmatic Breathing on Sleep Disorders in Polycystic Ovarian Syndrome

Polycystic ovarian syndrome (PCOS) is the most common endocrine disorder in females in reproductive age and not completely understood. Women with PCOS appear to have an increased frequency of sleep problems. Diaphragmatic Breathing (DB) exercises has positive effects on improving sleep quality. The purpose of this study will evaluate the effect of diaphragmatic breathing exercises on improving sleep quality in polycystic ovarian syndrome women.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Polycystic ovary syndrome (PCOS) is one of the most prevalent metabolic and reproductive disorders impacting women of reproductive age. Difficulty falling asleep and maintaining sleep has been reported among women with PCOS. Taken together, these data suggest that women with PCOS are at an increased risk for sleep disturbances, obesity and depression are associated with the increased risk. Pharmacotherapy is only recommended for the short term. This is particularly pertinent for women with PCOS whose insomnia and other sleep disturbances are unlikely to be short term and are related to underlying factors that need to be addressed directly. So, there is an urgent need to a safe method for PCOS women such as diaphragmatic breathing that need further more investigations which will be conducted in this study.

Studietype

Ingrijpend

Inschrijving (Geschat)

54

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

Studie Contact Back-up

Studie Locaties

  • Egypte
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypte, 11432
        • Werving
        • Cairo University; Faculty of Physical Therapy
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Naira H Mohamed, B.Sc

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

Nee

Beschrijving

Inclusion Criteria:

  • Women aged from 25-35 years old, Diagnosed with PCOS by gynecologist, diagnosis of PCOS will be based on the 2003 Rotterdam criteria.

    • They have a Pittsburgh sleep quality index (PSQI) score greater than 5.
    • Not participating in any physical exercise for the previous 3 months.
    • They have an insomnia severity index score greater than 15.
    • They have a fatigue severity scale score greater than 36.
    • Ability to use internet and phone services

Exclusion Criteria:

  • • Women with autoimmune diseases and cancer.

    • Women with neurological, mental, cardiopulmonary and musculoskeletal disorders.
    • Pregnant or lactating women.
    • Women who showed regular adherence to sleeping pills, antidepressants and hormonal replacement agents.
    • Inability to perform diaphragmatic breathing due to physical limitations.
    • Women who participate or receive any interventions that could affect their sleep

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: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Study group A (Diaphragmatic breathing group)
27 participants with sleep disorders related to polycystic ovarian syndrome. They will receive diaphragmatic breathing exercises three times per week, for 6 minutes twice a day and will receive lifestyle modification advices for 8 weeks
Ander: Diaphragmatic breathing exercises
Its course is 3 times per week, 6 minutes twice a day, for 8 weeks. When it's the first time to learn how to perform the diaphragmatic breathing technique, it's easier to follow the instructions lying down in supine position with a pillow under head. The patient will be asked to place one hand on her abdomen, just below her ribcage, and the other hand on the middle of her chest to become aware of her diaphragm's position and function during breathing. She will be told to breathe slowly and deeply through her nose and let her abdomen rise as much as possible. The length of the inhalation or exhalation should be 2-3 seconds
Ander: Lifestyle modification advices
Avoid caffeine, smoking, alcohol, napping; thirsty or hungry Regular exercising, sleep timing, relax techniques; Reduce noise, Ensure bedroom clean, no TV, mobile in bed, snack near bed, warm bath pre sleep, wear sleep cloths, most relaxed position for sleep.
Actieve vergelijker: Control Group B (Lifestyle modification advices group)
27 participants with sleep disorders related to polycystic ovarian syndrome. They will receive lifestyle modification advices only as group (A) for 8 weeks
Ander: Lifestyle modification advices
Avoid caffeine, smoking, alcohol, napping; thirsty or hungry Regular exercising, sleep timing, relax techniques; Reduce noise, Ensure bedroom clean, no TV, mobile in bed, snack near bed, warm bath pre sleep, wear sleep cloths, most relaxed position for sleep.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pittsburgh Sleep Quality Index (PSQI)
Tijdsspanne: Pre-treatment at baseline of the study Post-treatment after intervention completed by 8 weeks.
a reliable, valid, standardized measure of sleep quality, discriminate "good" and "poor" sleepers and provide an easy index for patients to complete. It's classified into seven subcategories: "subjective sleep quality" (1 item), "sleep latency" (2 items), sleep duration (1 item), habitual sleep efficiency (3 items), sleep disturbances (7 items), use of sleeping medication (1 item), and daytime dysfunction (3 items). Five additional questions rated by the respondent's roommate or bed partner are included for clinical purposes and are not scored, all seven-item scores were added together to generate a total score ranging from 0 to 21.
Pre-treatment at baseline of the study Post-treatment after intervention completed by 8 weeks.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Insomnia Severity Index (ISI)
Tijdsspanne: Pre-treatment at baseline of the study Post-treatment after intervention completed by 8 weeks.
A brief measure with only seven items, easily administered, All seven items are scored from 0 to 4, where higher scores indicate increasing severity of sleep disturbances and associated daytime symptoms, all seven-item scores were added together to generate a total score ranging from 0 to 28. The ISI has been translated into multiple languages, validated in 12 countries and as a web-based measurement.
Pre-treatment at baseline of the study Post-treatment after intervention completed by 8 weeks.
Fatigue Assessment Scale (FAS)
Tijdsspanne: Pre-treatment at baseline of the study Post-treatment after intervention completed by 8 weeks.
A 10-item self-reported scale evaluating symptoms of chronic fatigue, it measures both physical and mental symptoms. Each item of the FAS is answered using a five-point, Likert-type scale ranging from 1 ("never") to 5 ("always"). Items 4 and 10 are reverse-scored. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest. Since its introduction, the FAS was used in 26 different diseases or conditions, Its reliability and validity have proved to be good, the FAS is available in 20 languages and widely used
Pre-treatment at baseline of the study Post-treatment after intervention completed by 8 weeks.

Medewerkers en onderzoekers

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

Sponsor

Adly A Adam

Onderzoekers

  • Studie stoel: Soheir M Elkosery, Professor, Cairo University; Faculty of Physical Therapy
  • Studie directeur: Ahmed M Othman, Professor, Tanta University

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)

11 juli 2026

Primaire voltooiing (Geschat)

1 september 2026

Studie voltooiing (Geschat)

30 oktober 2026

Studieregistratiedata

Eerst ingediend

8 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

10 juli 2026

Eerst geplaatst (Werkelijk)

13 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

12 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • P.T.REC/012/005971

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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