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Diaphragmatic Breathing Exercises on Sleep Disorders un Polycystic Ovarian Syndrome

10. juli 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

54

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Egypten
      • Cairo, Egypten, 11432
        • Rekruttering
        • Cairo University; Faculty of Physical Therapy
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Naira H Mohamed, B.Sc

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

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Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Andet: 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
Andet: 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.
Aktiv komparator: 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
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pittsburgh Sleep Quality Index (PSQI)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Insomnia Severity Index (ISI)
Tidsramme: 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)
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Adly A Adam

Efterforskere

  • Studiestol: Soheir M Elkosery, Professor, Cairo University; Faculty of Physical Therapy
  • Studieleder: Ahmed M Othman, Professor, Tanta University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2025

Primær færdiggørelse (Anslået)

1. juli 2026

Studieafslutning (Anslået)

30. august 2026

Datoer for studieregistrering

Først indsendt

8. juli 2026

Først indsendt, der opfyldte QC-kriterier

10. juli 2026

Først opslået (Faktiske)

13. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P.T.REC/012/005971

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