Acupressure for Insomnia (AcuSnooze)
Acupressure for Chronic Insomnia in Adults With Chronic Low Back Pain
The purpose of this study is to examine the effect of 6-weeks of relaxation acupressure compared to stimulating acupressure or a standard of care on sleep and daytime functioning. Also, to evaluate the ability of teaching acupressure using web-based applications.
It is believed that self-administered relaxation acupressure will result in improvements of sleep quality and quantity as compared to stimulating acupressure or a standard of care.
研究概览
详细说明
Insomnia is a significant health problem and is associated with increased mental health issues: It is estimated that 9% to 15% of the adult population suffers from chronic insomnia. These estimates are considerably higher in primary care where from 20% to 33% suffer from chronic insomnia. Insomnia adversely affects psychological, physical and occupational functioning and places a significant burden on society. Moreover, several cohort studies have found that people with insomnia have significantly higher absenteeism at work, report poor self-esteem, less job satisfaction, and less efficiency at work compared to good sleepers.
Acupressure is a TCM technique based on a philosophy similar to that of acupuncture (the placement and stimulation of very fine needles into acupuncture points). Acupressure involves placing physical pressure by fingers, thumb, elbow, or with the aid of various devices such as pencil erasers on different acupuncture points (acupoints). Depending on the date of the review and the inclusion criteria, e.g., searched in Chinese language databases, there are anywhere from 7^12 to 4^68 randomized clinical trials (RCT) of various types of acupuncture (inclusive of acupressure) for treating insomnia. Regardless of the review the conclusions are remarkably consistent. Mainly, that the majority of RCTs demonstrated that acupuncture was significantly more effective than BDZs, sleep hygiene counseling, no treatment and sham acupuncture for treating insomnia.
The investigators will attempt to prove that self-administered Relaxation Acupressure (RA) will result in improvements in measures of sleep quality and quantity, compared to Stimulating Acupressure (SA) and a wait list control (WL). Also, that they will be able to teach the acupressure points using a web-based application.
Participants will be randomized into 1 of 3 arms; RA, SA, or WL (standard of care). If randomized into one of the acupressure arms, the participants will view their appropriate acupressure training lesson online and be tested on their understanding. They will also be asked to perform their acupoints once per day for a total of 6 weeks.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Michigan
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Ann Arbor、Michigan、美国、48105
- Domino's Farm
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 18-65 years of age
- Meet DSM-IV criteria for primary insomnia
- Insomnia must also be documented on two weeks of a baseline sleep diary
Exclusion Criteria:
- Diagnosis or high clinical suspicion of a sleep disorder other than insomnia
- Evidence of a unstable Axis I psychiatric disorder
- Evidence of an uncontrolled medical disorder or pain syndrome that affects sleep, causes daytime sleepiness, or is likely to be causally associated with the insomnia
- Current pharmacological or non-pharmacological insomnia treatment
- Routine overnight shift work
- Previous failed trial of acupuncture or acupressure
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预:Standard of Care
Participants will be asked to continue doing whatever their healthcare providers advise for their insomnia, but not to start any new treatments during the study.
They will also be given a sleep hygiene handout as a standard of care.
After six weeks, they will be reassessed and then provided the opportunity to engage in the web-based acupressure intervention.
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有源比较器:Relaxation Acupressure
In addition to being given a sleep hygiene handout as a standard of care, participants will be asked to apply pressure on each of following points (bilaterally where indicated).
There are 5 acupoints with 4 of the acupoints performed on both the left and the right sides of the body giving a total of 9 points to stimulate.
Each of the 9 acupoints will be stimulated for 3 minutes per point giving a total treatment time of 27 minutes done once daily.
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Apply pressure (stimulate) to the 9 acupoints for 3 minutes per point giving a total treatment time of 27 minutes done once daily for a period of 6 weeks.
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有源比较器:Stimulating Acupressure
In addition to being given a sleep hygiene handout as a standard of care, participants will be asked to apply pressure on each of following points (bilaterally where indicated).
There are 6 acupoints with 4 of the acupoints performed on both the left and the right sides of the body giving a total of 10 points to stimulate.
Each of the 10 acupoints will be stimulated for 3 minutes per point giving a total treatment time of 30 minutes done once daily.
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Apply pressure (stimulate) to the 10 excitatory acupoints for 3 minutes per point giving a total treatment time of 30 minutes done once daily for a period of 6 weeks.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Difference in the effect of 6-weeks of Relaxation Acupressure compared to Stimulating Acupressure or standard of care on chronic insomnia and daytime functioning.
大体时间:6 weeks
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Insomnia will be assessed/determined by daily sleep/wake diaries and the Insomnia Severity Index questionnaire. Sleep Diary: insomnia = <85% sleep efficiency ratio. Daytime functioning will be determined by the Fatigue Severity Scale of Sleep Disorders (FSS). |
6 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Success of teaching the acupressure interventions using a novel web-based application measured by an Acupressure Fidelity Form at week 1 and week 6.
大体时间:6 weeks
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The success of learning acupressure via a web-based application will be assessed using an Acupressure Fidelity Form.
The form will assess the participants ability to locate each acupressure point, demonstrate proper pressure/technique, and know the frequency of their treatments.
Acupressure Form A is worth a total of 12 points while Form B is worth 13 points.
Each correct answer is worth 1 point.
We will consider our web based intervention "successful" if 95% of participants (49 of them) received a score of 100% at both visits.
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6 weeks
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合作者和调查者
调查人员
- 首席研究员:Suzanna M Zick, ND, MPH、, Department of Family Medicine, University of Michigan
- 首席研究员:Richard E Harris, PhD、, Departments of Anesthesiology and Internal Medicine, University of Michigan
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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