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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04188340
• Other study ID #: CMUH107-REC1-031
• Status: Completed
• Phase: N/A
• Start date: April 18, 2018
• Est. completion date: April 2, 2019

Study information

• Verified date: December 2019
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 2, 2019
• Est. primary completion date: April 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Su-Man formula massage oil
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%.

Locations

Country	Name	City	State
Taiwan	ZEN chinese medicine clinic	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chinese version of Pittsburgh Sleep Quality Index	Evaluate the sleep quaility of participants	5mins
Secondary	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
Secondary	Chinese version of Insomnia Severity Index	Evaluate the sleep quaility	5mins
Secondary	Chinese version of Beck Anxiety Inventory	measuring the severity of anxiety	5mins