Therapeutic Effect of Self-administered Auricular Acupressure on Insomnia Induced by Anxiety: A Randomized Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Hamilton Anxiety Rating Scale (HAM-A)
研究概览
简要总结
This is a sham-controlled randomized trial to identify the effectiveness of treating insomnia induced by anxiety with self-administered auricular acupressure in Malaysia.
详细描述
112 subjects with insomnia and anxiety who fit to the inclusion and exclusion criteria will be recruited into the trial. After initial screening, subjects will be randomly allocated to Vaccaria seed tapes (experimental arm) or non-Varracia seed plain tapes (sham comparator arm).
On the sixth day for the trial (after 5 days of daily auricular acupressure), the ISI and HAM-A score of subjects will be reassessed again. The subjects have to stop applying auricular acupressure for the next five days and reassess their ISI and HAM-A score again on the eleventh day.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All Malaysian aged above 18 years old who are suffering from chronic insomnia based on International Classification of Sleep Disorders 3(ICSD-3) and with Insomnia Severity Index (ISI) of 18 and above and more than 3 months.
- •Willing to comply with the recommended periodic acupressure stimulation every day during the 1 week period.
排除标准
- •Subject with insomnia score below 18 based on Insomnia Severity Index (ISI).
- •Subject with stress and anxiety level below 18 in the Hamilton Anxiety Rating Scale (HAM-A).
- •Subject with the history of skin sensitivity.
- •Subject who just started on new medication to treat insomnia.
结局指标
主要结局
Hamilton Anxiety Rating Scale (HAM-A)
时间窗: 11th day
Total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Insomnia Severity Index (ISI)
时间窗: 11th day
Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
次要结局
未报告次要终点
研究者
Tang Sin Wei
Lecturer
IMU University, Malaysia