Diaphragmatic Breathing Exercises on Sleep Disorders un Polycystic Ovarian Syndrome

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-35
SponsorAdly A Adam

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

• 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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Diaphragmatic breathing exercises

    Other intervention

    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

  • Lifestyle modification advices

    Other intervention

    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.

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: Study group A (Diaphragmatic breathing group)Experimental treatment 2 interventions
Group B: Control Group B (Lifestyle modification advices group)Active comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Insomnia Severity Index (ISI)

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.

Time frame
Pre-treatment at baseline of the study Post-treatment after intervention completed by 8 weeks.
2

Fatigue Assessment Scale (FAS)

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Adly A Adam

Lead sponsor

Cairo University

Sponsor institution