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Completed

NCT Number: NCT04188340

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

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

Completed

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Key information

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ZEN chinese medicine clinic

New Taipei City, 235, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Su-Man formula massage oil

Behavioral

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

Primary outcomes

  1. Chinese version of Pittsburgh Sleep Quality Index

    Time frame: 5mins

    Evaluate the sleep quaility of participants

Secondary outcomes

  1. M.E.A.D (Meridian Energy Analysis Device)

    Time frame: 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

    Time frame: 5mins

    Evaluate the sleep quaility

  3. Chinese version of Beck Anxiety Inventory

    Time frame: 5mins

    measuring the severity of anxiety

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 5, 2019
Registry last updated
Dec 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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