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临床试验/NCT04188340
NCT04188340已完成不适用

Effect of Su-Man Formula Massage Oil Acupressure on Sleep Quality and Anxiety in Patients With Insomnia

China Medical University Hospital2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2018年4月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
2
主要终点
Chinese version of Pittsburgh Sleep Quality Index

研究概览

简要总结

The present study predict that Su-Man formula massage oil acupressure can improved sleep quality.

详细描述

About 7% person in general population became as insomnia every year, and that has 30% person due to insomnia induces other symptoms such as anxiety. In addition, the incidence of insomnia in the female is 50% more than in the male. Insomnia belong to the scope of bù-mèi in traditional Chinese Medicine (TCM). TCM consider that the cause of insomnia is due to unbalance between yin and yang, and acupressure can treat insomnia. Several studies report that aromatherapy can enhance sleepy. Therefore, the purpose of the present study was to assess the therapeutic effect of Su-Man formula massage oil associates with acupressure on sleepy quality and anxiety lysis. A total 40 patients with insomnia divided into two groups, each group is 20 patients as follows: 1) control group, using bergamot massage oil apply to GV20, GV24 SP6, HT7 and PC6 acupoints, and massage for 10 times before sleep continuously 28 days; 2) test group, using Su-Man formula massage oil ap-ply to GV20, GV24, SP6, HT7 and PC6 acupoints, and massage for 10 times before sleep continuously 28 days. The primary outcome measurement is the Chinese version of Insomnia Severity In-dex(ISI-C), Pittsburgh Sleep Quality Index (CPSQI), and Beck Anxiety Inventory(BAI); The secondary outcome measure is the changes of meridian energy.

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)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who has poor sleep status attaining a score of 5 on the Chinese Pittsburgh Sleep Quality Index
  • 20-50 years

排除标准

  • having asthma or any diseases involving notable organ damage (e.g., heart, lungs, liver, or kidney failure or severe olfactory dysfunction)
  • being pregnant
  • being breastfeeding
  • have reached menopause
  • taking any medicine for improving sleep or anxiolytic drugs
  • be allergic to the oil that this study used.
  • having skin problem over the applying area,
  • having smoking and alchol drinking habit
  • inability to participate in the full course of the intervention courses

结局指标

主要结局

Chinese version of Pittsburgh Sleep Quality Index

时间窗: 5mins

Evaluate the sleep quaility of participants

次要结局

  • Chinese version of Insomnia Severity Index(5mins)
  • Chinese version of Beck Anxiety Inventory(5mins)
  • M.E.A.D (Meridian Energy Analysis Device)(10mins)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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