Effect of Su-Man Formula Massage Oil Acupressure on Sleep Quality and Anxiety in Patients With Insomnia
Primary Purpose
Insomnia
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Su-Man formula massage oil
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Su-Man formula massage oil, Acupressure, Meridian energy, Insomnia
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
Sites / Locations
- ZEN chinese medicine clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
control group
test group
Arm Description
using bergamot massage oil apply to GV20, GV24 SP6, HT7 and PC6 acupoints, and massage for 20 times before sleep continuously 28 days
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
Outcomes
Primary Outcome Measures
Chinese version of Pittsburgh Sleep Quality Index
Evaluate the sleep quaility of participants
Secondary Outcome Measures
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.
Chinese version of Insomnia Severity Index
Evaluate the sleep quaility
Chinese version of Beck Anxiety Inventory
measuring the severity of anxiety
Full Information
NCT ID
NCT04188340
First Posted
May 14, 2018
Last Updated
December 3, 2019
Sponsor
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04188340
Brief Title
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
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 18, 2018 (Actual)
Primary Completion Date
April 2, 2019 (Actual)
Study Completion Date
April 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Su-Man formula massage oil, Acupressure, Meridian energy, Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
using bergamot massage oil apply to GV20, GV24 SP6, HT7 and PC6 acupoints, and massage for 20 times before sleep continuously 28 days
Arm Title
test group
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Su-Man formula massage oil
Other Intervention Name(s)
bergamot massage oil
Intervention Description
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%.
Primary Outcome Measure Information:
Title
Chinese version of Pittsburgh Sleep Quality Index
Description
Evaluate the sleep quaility of participants
Time Frame
5mins
Secondary Outcome Measure Information:
Title
M.E.A.D (Meridian Energy Analysis Device)
Description
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.
Time Frame
10mins
Title
Chinese version of Insomnia Severity Index
Description
Evaluate the sleep quaility
Time Frame
5mins
Title
Chinese version of Beck Anxiety Inventory
Description
measuring the severity of anxiety
Time Frame
5mins
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching-Liang Hsieh, PhD
Organizational Affiliation
China Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
ZEN chinese medicine clinic
City
New Taipei City
ZIP/Postal Code
235
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Su-Man Formula Massage Oil Acupressure on Sleep Quality and Anxiety in Patients With Insomnia
We'll reach out to this number within 24 hrs