Effects of Internet - Based Cognitive Behavioral Therapy on Sleep Quality Among a Sample of Saudi Postmenopausal Women
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- change sleep quality post intervention
研究概览
简要总结
Sleep problems become more prominent with aging and worse among post-menopause than perimenopause stage. The actual causes of sleep problems are unclear. However, it occurs commonly accompanied with or in the response of seriousness of menpausal symptoms as nocturnal hot flashes, mood disorders, and obstructive sleep apnea among menopauses. The Prevalence of sleep problems is variable ranged from 11.8 -62 % based on different studies.
Cognitive-behavioral therapy (CBT) is one of the short-term form of psychotherapy, used for managing sleep problems and insomnia , an efficacious as pharmacological treatment.
详细描述
As life expectancy has increased, women spend more than one-third of their lives in menopausal transition (MT) and the subsequent post menopause (PM).As a result of hormonal changes women experiences such symptoms as hot flashes, mood swings, anxiety, and sexual dysfunction that deteriorate their quality of life. Those symptoms usually begin in 45-53-year-olds and it varies in onset and severity from women to another and from country to another.
Symptoms of sleep problems include the difficulty of falling asleep, fractioned sleep, night-time awakening, the inability of resuming sleep, problems in waking up, fatigue, and daytime sleepiness that potentiate poor physical and mental quality of life.
The goal of CBT is to teach women how to modify maladaptive behaviors and thoughts that may contribute to a particular problem as sleep problems, anxious thoughts, and vasomotor symptoms
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
all participants will randomly assign to either an internet-based group and control group through a generated computer selection
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Menopaused women age between 50 and65 years
- •Able to read and write
- •Being normally ( primary ) menopause at least one year
- •Willing to give written informed consent to participate in the study.
- •Women obtaining more than 5 of the total score of the Pittsburgh Sleep Quality Index (PSQI)( that indicates poor sleep )
- •Have smartphone with internet access (WhatsApp) application
排除标准
- •Has serious physical disorders or uncontrolled conditions as uncontrolled blood pressure , uncontrolled blood glucose level, on hemodialysis
- •Receiving psychotropic medications, hormone replacement therapy (HRT),
- •Undergoing hysterectomy
- •Has acute or chronic surgical conditions, cancer or any other serious illness
- •Has cognitive impairments or physical handicap
- •Giving prescribed or non-prescribed medication or herbals that influencing sleep .
结局指标
主要结局
change sleep quality post intervention
时间窗: 8 weeks (two weeks ( introductory sessions ) pluse six weeks ( intervention sessions)
improve quality of sleep than before intervention before intervention
change insomnia related to post menpausal symptoms post intervention
时间窗: 8 weeks (two weeks ( introductory sessions ) pluse six weeks ( intervention sessions)
decrease insomnia index score post intervention
次要结局
- change menopausal symptoms post intervention(at the end of intervention program ( 8 weeks))
研究者
Enas Mahrous AbdelAziz
Assistant professor
Jouf University