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

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

Detailed Description
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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.

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

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Su-Man formula massage oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who has poor sleep status attaining a score of 5 on the Chinese Pittsburgh Sleep Quality Index 20-50 years Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients with insomnia divided into two groups, each group is 20 patients as follows: 1) control group, using sweet al mond o il apply to GV20, GV24 SP6 , HT7 and PC6 acupoints, and massage for 10 times before sleep continuously 28 days; 2) treatment group, using Su Man formula m assage oil apply to GV20, GV24 , SP6 , HT7 and PC6 acupoints, and massage for 10 times before sleep cont inu ously 28 days.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br>using bergamot massage oil apply to GV20, GV24 SP6, HT7 and PC6 acupoints, and massage for 20 times before sleep continuously 28 days | Behavioral: Su-Man formula massage oil<br>* bergamot massage oil:dilute bergamot essential oil(0.5%) with almond oil Su-Man formula massage oil: mixed 4 different essential oil include bergamot, red mandarin, petit grain bigarade, spikenard and diluted with almond oil 5%.<br>* Other names: bergamot massage oil;|
| Experimental: test group<br>using Su-Man formula massage oil ap-ply to GV20, GV24, SP6, HT7 and PC6 acupoints, and massage for 20 times before sleep continuously 28 days | Behavioral: Su-Man formula massage oil<br>* bergamot massage oil:dilute bergamot essential oil(0.5%) with almond oil Su-Man formula massage oil: mixed 4 different essential oil include bergamot, red mandarin, petit grain bigarade, spikenard and diluted with almond oil 5%.<br>* Other names: bergamot massage oil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chinese version of Pittsburgh Sleep Quality Index | Evaluate the sleep quaility of participants | 5mins | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| M.E.A.D (Meridian Energy Analysis Device) | The instrument mainly detects 24 representative points of the twelve meridians around the human body. The bioelectrical resistance of each meridian is measured by the test rod to evaluate the conductivity of each meridian, and the physiology of the subject is analyzed by computer. situation. | 10mins | 
| Chinese version of Insomnia Severity Index | Evaluate the sleep quaility | 5mins | 
| Chinese version of Beck Anxiety Inventory | measuring the severity of anxiety | 5mins | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Su-Man formula massage oil, Acupressure, Meridian energy, Insomnia