Skip to content

Diaphragmatic Breathing Exercises on Sleep Disorders un Polycystic Ovarian Syndrome

Effect of Diaphragmatic Breathing on Sleep Disorders in Polycystic Ovarian Syndrome

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07698925
Enrollment
54
Registered
2026-07-13
Start date
2026-07-11
Completion date
2026-10-30
Last updated
2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaphragmatic Breathing Exercise, Fatigue Severity Scale, Insomnia Severity Index, Pittsburg Sleep Quality Index, Polycystic Ovarian Syndrome (PCOS), Sleep Disorders

Keywords

Polycystic ovary syndrome, Diaphragmatic breathing exercises, Sleep disorders, Pittsburg sleep quality index, Insomnia severity index, Fatigue severity scale

Brief summary

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.

Detailed description

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.

Interventions

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

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.

Sponsors

Adly A Adam
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Another researcher via an opaque envelopes involved number defining the 80 post stroke participants, then randomly allocated

Intervention model description

Randomized Controlled Trial

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 35 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pittsburgh Sleep Quality Index (PSQI)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.

Secondary

MeasureTime frameDescription
Insomnia Severity Index (ISI)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.
Fatigue Assessment Scale (FAS)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

Countries

Egypt

Contacts

CONTACTNaira H Mohamed, B.Sc
nairahesham083@gmail.com01287797493
CONTACTMai M Shehata, PHD
adampt80a@gmail.com01287797493
STUDY_CHAIRSoheir M Elkosery, Professor

Cairo University; Faculty of Physical Therapy

STUDY_DIRECTORAhmed M Othman, Professor

Tanta University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 15, 2026