The Effects of Acupuncture on Insomnia Among Midlife Women: A Randomized Clinical Trail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Pittsburgh sleep quality index (PSQI)
研究概览
简要总结
Aims: To explore the effects of acupuncture on the improvement of insomnia, fatigue, depression and menopausal symptoms among midlife women.
详细描述
This research is a study with a randomized clinical trial. Participants were 40-60 years old with a sleep disturbance which persists more than one month. Twenty participants were randomly assigned into the experimental and control groups. The experimental group received acupuncture treatment (Taichong, Shenmen, Neiguan points) twice a week, total three weeks, plus sleep hygiene guidance; the control group received subcutaneous acupuncture (non-therapeutic acupuncture points) twice a week, total three weeks and given sleep Health guidance. All participants received pre-test and post-test, including sleep multiple physiological examination (PSG), Pittsburgh sleep quality table, Epworth sleepiness scale, hospital anxiety depression scale, menopausal symptom questionnaire, sleep disturbance comprehensive scale, and wore Actiwatch for three days. Data analysis was performed using SPSS.
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
- Single (Participant)
盲法说明
The patients will not know that they are recieving acupuncture or sham acupuncture
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 40-60 years
- •Complaints of insomnia symptoms in the past month that lasted for at least one week, such as difficulty falling asleep, waking up easily in the middle of the night, unable to fall asleep after waking up, still not getting enough sleep after waking up in the morning
- •The score of sleep disorder on the Pittsburgh Sleep Quality Scale was more than 5 points
排除标准
- •History of psychiatric disorders
- •History of sleep apnea or nocturnal myoclonus
- •Center or neurodegenerative disease
- •Melatonin or sleeping pills use in the past month
研究组 & 干预措施
The experimental group received acupuncture treatment
The experimental group received acupuncture treatment (Taichong, Shenmen, Neiguan points) twice a week, total three weeks, plus sleep hygiene guidance
干预措施: Acupuncture (Other)
The control group received subcutaneous sham acupuncture
The control group received subcutaneous acupuncture (non-therapeutic acupuncture points) twice a week, total three weeks and given sleep Health guidance.
干预措施: Acupuncture (Other)
结局指标
主要结局
Pittsburgh sleep quality index (PSQI)
时间窗: 15 minutes
The scale is suitable for the evaluation of sleep quality in patients with sleep disorders and mental disorders, as well as for the evaluation of sleep quality in general people.
次要结局
- Global Physical Activity Questionnaire(15 minutes)
- Epworth Sleepiness Scale (ESS)(15 minutes)
- Hospital Anxiety and Depression Scale (HADS)(15 minutes)
- Total sleep time (TST)(8 hours)
- Minimum spo2 level during sleep(8 hours)
- Wake time after sleep onset (WASO)(8 hours)
- Sleep Latency(8 hours)
- Snore Outcomes Survey (SOS)(15 minutes)
- Percentage of rapid eye movement (REM) stage(8 hours)
- Mean heart rate during REM(8 hours)
- Sleep efficiency (SE)(8 hours)