Clinical trial NCT04188340: Effect of Su-Man Formula Massage Oil Acupressure on Sleep Quality and Anxiety in Patients With Insomnia
Official title: Effect of Su-Man Formula Massage Oil Acupressure on Sleep Quality and Anxiety in Patients With Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Su-Man formula massage oil
Acupressure
Meridian energy
Insomnia
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 38
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Chinese version of Pittsburgh Sleep Quality Index
timeFrame: 5mins
Secondary outcomes:
measure: M.E.A.D (Meridian Energy Analysis Device)
timeFrame: 10mins
measure: Chinese version of Insomnia Severity Index
timeFrame: 5mins
measure: Chinese version of Beck Anxiety Inventory
timeFrame: 5mins
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: ZEN chinese medicine clinic
Study officials:
affiliation: China Medical University, China
name: Ching-Liang Hsieh, PhD
role: PRINCIPAL_INVESTIGATOR
References: