Effect of auricular acupuncture at Shenmen and insomnia point on quality of sleep in patients with insomnia: A randomized placebo controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Quality of Sleep: Pittsburgh sleep quality index (PSQI)
研究概览
简要总结
A randomized placebo-controlled study design will be adopted for this study. All the eligible subjects will be randomly divided into 2 groups. The study group will undergo needling at auricular acupuncture points i.e., Shenmen and Insomnia point for 30 minutes a day, 5 days a week for 2 weeks, whereas, the placebo-control group will undergo needling at non-auricular acupuncture points for 30 minutes a day, 5 days a week for 2 weeks . Assessment of quality of sleep will be measured using Pittsburgh sleep quality index (PSQI).Severity of Insomnia will be measured using Insomnia Severity Index (ISI). Daytime sleepiness will be measured using Epworth Sleepiness Scale (ESS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed as insomnia using Diagnostic and Statistical Manual of Mental Disorders, (DSM –V) criteria.
- •Willingness and ability to accept needle acupuncture intervention.
排除标准
- •Patients with cardiovascular diseases, cerebrovascular diseases & chronic kidney disease.
- •Patients on sedative drugs like barbiturates and benzodiazepines Needle phobia People who are pregnant, lactating and menstruating.
- •Patients working in shift basis involving frequent and regular changes in day and night work schedule that impacts circadian rhythm.
结局指标
主要结局
Quality of Sleep: Pittsburgh sleep quality index (PSQI)
时间窗: Quality of Sleep: Pittsburgh sleep quality index (PSQI) Assessment of quality of sleep will be measured using Pittsburgh sleep quality index (PSQI) before and after 2 weeks of intervention.
次要结局
- Severity of Insomnia: Insomnia Severity Index (ISI)(It will be measured using Insomnia Severity Index (ISI) before and after 14 days of intervention.)
- Daytime sleepiness: Epworth Sleepiness Scale (ESS)(Assessment of daytime sleepiness will be measured using Epworth Sleepiness Scale (ESS) before and after 2 weeks of intervention.)
研究者
Dr Ezhiloviam
Government Yoga and Naturopathy Medical College and Hospital