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Recruiting NCT07698925

Diaphragmatic Breathing Exercises on Sleep Disorders un Polycystic Ovarian Syndrome

No phase Interventional Polycystic Ovarian Syndrome (PCOS) Pittsburg Sleep Quality Index Fatigue Severity Scale Insomnia Severity Index

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diaphragmatic breathing exercises, Lifestyle modification advices.
Who it may be relevant to
Registry conditions: Polycystic Ovarian Syndrome (PCOS), Pittsburg Sleep Quality Index, Fatigue Severity Scale, Insomnia Severity Index. Basic parameters: 25 years — 35 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Diaphragmatic Breathing on Sleep Disorders in Polycystic Ovarian Syndrome

Overview

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

  • Other 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 deepl
  • Other 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.

Primary outcome measures

  • Pittsburgh Sleep Quality Index (PSQI) [Time frame: Pre-treatment at baseline of the study Post-treatment after intervention completed by 8 weeks.]
Secondary outcome measures (2)
  • Insomnia Severity Index (ISI) [Time frame: Pre-treatment at baseline of the study Post-treatment after intervention completed by 8 weeks.]
  • Fatigue Assessment Scale (FAS) [Time frame: Pre-treatment at baseline of the study Post-treatment after intervention completed by 8 weeks.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Cairo University; Faculty of Physical Therapy — Cairo

Identifiers

NCT: NCT07698925 · P.T.REC/012/005971

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗