Diaphragmatic Breathing Exercises on Sleep Disorders un Polycystic Ovarian Syndrome

NCT07698925 | Recruiting DMC

• 1 other identifier: P.T.REC/012/005971
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index (PSQI)

  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.

Secondary Outcomes (2)

• Insomnia Severity Index (ISI)

  Pre-treatment at baseline of the study Post-treatment after intervention completed by 8 weeks.

• Fatigue Assessment Scale (FAS)

  Pre-treatment at baseline of the study Post-treatment after intervention completed by 8 weeks.

Study Arms (2)

Study group A (Diaphragmatic breathing group)

EXPERIMENTAL

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

Other: Diaphragmatic breathing exercises; Other: Lifestyle modification advices

Control Group B (Lifestyle modification advices group)

ACTIVE COMPARATOR

27 participants with sleep disorders related to polycystic ovarian syndrome. They will receive lifestyle modification advices only as group (A) for 8 weeks

Other: Lifestyle modification advices

Interventions

Diaphragmatic breathing exercises OTHER

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

Study group A (Diaphragmatic breathing group)

Lifestyle modification advices OTHER

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.

Control Group B (Lifestyle modification advices group); Study group A (Diaphragmatic breathing group)

Eligibility Criteria

• Age: 25 Years - 35 Years
• Gender Eligibility Details: Polycystic ovarian syndrome is an endocrine disorder in females in reproductive age therefore, it is a must to target female population.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adly A Adam: lead

Study Sites (1)

Cairo University; Faculty of Physical Therapy

Cairo, Cairo Governorate, 11432, Egypt

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Soheir M Elkosery, Professor

  Cairo University; Faculty of Physical Therapy

  STUDY CHAIR

• Ahmed M Othman, Professor

  Tanta University

  STUDY DIRECTOR

Central Study Contacts

Naira H Mohamed, B.Sc

CONTACT

01287797493; nairahesham083@gmail.com

Mai M Shehata, PHD

CONTACT

01287797493; adampt80a@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Another researcher via an opaque envelopes involved number defining the 80 post stroke participants, then randomly allocated
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physical Therapy

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 13, 2026
• Study Start: July 11, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)