Effect of Diaphragmatic Breathing on Sleep Disorders in Polycystic Ovarian Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Another researcher via an opaque envelopes involved number defining the 80 post stroke participants, then randomly allocated
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •Not participating in any physical exercise for the previous 3 months.
- •They have an insomnia severity index score greater than
- •They have a fatigue severity scale score greater than
- •Ability to use internet and phone services
排除标准
- •• 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
研究组 & 干预措施
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
干预措施: Diaphragmatic breathing exercises (Other)
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
干预措施: Lifestyle modification advices (Other)
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
干预措施: Lifestyle modification advices (Other)
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI)
时间窗: 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.
次要结局
- 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.)
研究者
Adly A Adam
Physical Therapy
Cairo University