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

Sponsor
China Medical University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04188340
Collaborator
(none)
38
Enrollment
1
Location
2
Arms
11.5
Actual Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Su-Man formula massage oil
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Su-Man Formula Massage Oil Acupressure on Sleep Quality and Anxiety in Patients With Insomnia
Actual Study Start Date :
Apr 18, 2018
Actual Primary Completion Date :
Apr 2, 2019
Actual Study Completion Date :
Apr 2, 2019

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: control group

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
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%.
Other Names:
  • bergamot massage oil

    		•
    Experimental: test group

    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
    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%.
    Other Names:
  • bergamot massage oil

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Chinese version of Pittsburgh Sleep Quality Index [5mins]

      Evaluate the sleep quaility of participants

    Secondary Outcome Measures

    1. M.E.A.D (Meridian Energy Analysis Device) [10mins]

      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.

    2. Chinese version of Insomnia Severity Index [5mins]

      Evaluate the sleep quaility

    3. Chinese version of Beck Anxiety Inventory [5mins]

      measuring the severity of anxiety

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ZEN chinese medicine clinic New Taipei City Taiwan 235

    Sponsors and Collaborators

    • China Medical University Hospital

    Investigators

    • Principal Investigator: Ching-Liang Hsieh, PhD, China Medical University, China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    China Medical University Hospital
    ClinicalTrials.gov Identifier:
    NCT04188340
    Other Study ID Numbers:
    • CMUH107-REC1-031
    First Posted:
    Dec 5, 2019
    Last Update Posted:
    Dec 5, 2019
    Last Verified:
    Dec 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by China Medical University Hospital
    Su-Man formula massage oil
    Acupressure
    Meridian energy
    Insomnia
    Additional relevant MeSH terms:
    Sleep Initiation and Maintenance Disorders

    Study Results

    No Results Posted as of Dec 5, 2019