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

NCT ID: NCT04188340

Last Updated: 2019-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-18

Study Completion Date

2019-04-02

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.

Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type PLACEBO_COMPARATOR

Su-Man formula massage oil

Intervention Type 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%.

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

Group Type EXPERIMENTAL

Su-Man formula massage oil

Intervention Type 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%.

Interventions

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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%.

Intervention Type BEHAVIORAL

Other Intervention Names

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bergamot massage oil

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ching-Liang Hsieh, PhD

Role: PRINCIPAL_INVESTIGATOR

China Medical University, China

Locations

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ZEN chinese medicine clinic

New Taipei City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CMUH107-REC1-031

Identifier Type: -

Identifier Source: org_study_id

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