Auricular Acupressure for Perimenopausal Women With Anxiety (AAA)
Primary Purpose
Auricular Acupressure, Anxiety, Menopause
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
auricular acupressure
sham acupressure
Sponsored by
About this trial
This is an interventional treatment trial for Auricular Acupressure focused on measuring acupressure, perimenopause, menopause, anxiety, life quality, insomnia
Eligibility Criteria
Inclusion Criteria:
- age between 40 to 60 years
- irregular menstrual cycle less than 12 months or no menstrual cycle less than 10 years
- FSH level>= 14 IU/L
- Brief symptom rating scale total scores>= 6
Exclusion Criteria:
- severe medical conditions
- substance dependence or abuse
- contraindication of BZDs
- contraindication of acupressure
- other primary anxiety disorder and major psychosis
- use hormone therapy
- use herb medicine
Sites / Locations
- Chang-Hua HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Acupressure acupressure
sham acupressure
Arm Description
Outcomes
Primary Outcome Measures
Hamilton Anxiety Rating Scale
Secondary Outcome Measures
Menopause Rating Scale,Short Form Health Survey(SF-36),CGI
Full Information
NCT ID
NCT01056458
First Posted
January 25, 2010
Last Updated
May 28, 2010
Sponsor
Chang-Hua Hospital
Collaborators
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01056458
Brief Title
Auricular Acupressure for Perimenopausal Women With Anxiety
Acronym
AAA
Official Title
Effect of Auricular Acupressure on Perimenopausal and Early Postmenopausal Women With Anxiety: a Double Blinded, Randomized and Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
January 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Chang-Hua Hospital
Collaborators
China Medical University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is expected to show auricular acupressure therapy help to improve the anxiety symptoms of perimenopausal and early postmenopausal women, looking forward to developing a convenient, safe and effective way to reduce the use of sedative hypnotics and their dependencies, thereby improving their quality of life.
Detailed Description
There are several stages of women while they were particularly vulnerable to anxiety and insomnia , especially in the pre-menstruation, pregnancy, postpartum, and menopause stage. Sleep problems are common in menopausal and postmenopausal women, its prevalence can be based on research from 15% to 60%. As for anxiety, the prevalence of women in this population can reach 53.7%. Several studies overseas have already pointed out that the improvement of acupuncture for anxiety disorders have had pretty good results. As auricular acupressure with a simple operation and the advantages of non-invasive, our interest is to explore the clinical benefit of combined auricular acupressure and medical therapy on anxiety and insomnia improvement in menopausal and early post-menopausal women. We design a double-blind, randomized controlled study, the subjects are ninety 40 to 60 years old women, during perimenopause and early postmenopause who are accompanied by anxiety symptoms. They were randomly divided into experimental and control groups, use the tape of ear adhesive beads on shenmen and subcortical area of both ears after three meals and before bed for three minutes each area with alternating ears, twice a week to replace paste. A total treatment time is eight times and a total of four weeks. Primary efficacy assessment (primary outcome measure) for the Hamilton Anxiety Rating Scale (HAMA) total score change. Secondary efficacy assessments (secondary outcome measure) for: 1) Menopause Rating Scale (MRS) scores; 2) Short Form Health Survey (SF-36) scores; 3) Clinical Global Impression-Severity (CGI-S) scores; and 4) Clinical Global Impression-Improvement (CGI-I) score changes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Auricular Acupressure, Anxiety, Menopause, Insomnia
Keywords
acupressure, perimenopause, menopause, anxiety, life quality, insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupressure acupressure
Arm Type
Active Comparator
Arm Title
sham acupressure
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
auricular acupressure
Other Intervention Name(s)
acupressure
Intervention Description
use the tape of ear adhesive beads on shenmen and subcortical area of both ears after three meals and before bed for three minutes each area with alternating ears, twice a week to replace paste.
Intervention Type
Other
Intervention Name(s)
sham acupressure
Other Intervention Name(s)
acupressure
Intervention Description
use only tape without ear adhesive beads under the same ways
Primary Outcome Measure Information:
Title
Hamilton Anxiety Rating Scale
Time Frame
4 weeks aftter ear acupressure
Secondary Outcome Measure Information:
Title
Menopause Rating Scale,Short Form Health Survey(SF-36),CGI
Time Frame
4 weeks aftter ear acupressure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age between 40 to 60 years
irregular menstrual cycle less than 12 months or no menstrual cycle less than 10 years
FSH level>= 14 IU/L
Brief symptom rating scale total scores>= 6
Exclusion Criteria:
severe medical conditions
substance dependence or abuse
contraindication of BZDs
contraindication of acupressure
other primary anxiety disorder and major psychosis
use hormone therapy
use herb medicine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ching-Ling Kao, MD
Phone
886-4-8298686
Ext
1805
Email
chinglingkao@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ching-Liang Hsieh, MD,PhD
Phone
886-4-22053366
Ext
3609
Email
clhsieh@mail.cmuh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching-Ling Kao, MD
Organizational Affiliation
Chang-Hua Hospital, Department of Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang-Hua Hospital
City
Changhua
ZIP/Postal Code
513
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ching-Ling Kao, MD
Phone
4886-4-8298686
Ext
1805
Email
chinglingkao@gmail.com
First Name & Middle Initial & Last Name & Degree
Ching-Ling Kao, MD
12. IPD Sharing Statement
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Auricular Acupressure for Perimenopausal Women With Anxiety
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