Auricular Acupressure for Perimenopausal Women With Anxiety (AAA)
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Auricular Acupressure Anxiety Menopause Insomnia |
Other: auricular acupressure Other: sham acupressure |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Effect of Auricular Acupressure on Perimenopausal and Early Postmenopausal Women With Anxiety: a Double Blinded, Randomized and Controlled Study |
- Hamilton Anxiety Rating Scale [ Time Frame: 4 weeks aftter ear acupressure ] [ Designated as safety issue: Yes ]
- Menopause Rating Scale,Short Form Health Survey(SF-36),CGI [ Time Frame: 4 weeks aftter ear acupressure ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 90 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Acupressure acupressure |
Other: auricular acupressure
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.
Other Name: acupressure
|
| Sham Comparator: sham acupressure |
Other: sham acupressure
use only tape without ear adhesive beads under the same ways
Other Name: acupressure
|
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.
Eligibility| Ages Eligible for Study: | 40 Years to 60 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Ching-Ling Kao, MD | 886-4-8298686 ext 1805 | chinglingkao@gmail.com |
| Contact: Ching-Liang Hsieh, MD,PhD | 886-4-22053366 ext 3609 | clhsieh@mail.cmuh.org.tw |
| Taiwan | |
| Chang-Hua Hospital | Recruiting |
| Changhua, Taiwan, 513 | |
| Contact: Ching-Ling Kao , MD 4886-4-8298686 ext 1805 chinglingkao@gmail.com | |
| Principal Investigator: Ching-Ling Kao, MD | |
| Principal Investigator: | Ching-Ling Kao, MD | Chang-Hua Hospital, Department of Health |
More Information
No publications provided
| Responsible Party: | Ching-Ling Kao, MD, Chang-Hua Hospital |
| ClinicalTrials.gov Identifier: | NCT01056458 History of Changes |
| Other Study ID Numbers: | 98DMR291 |
| Study First Received: | January 25, 2010 |
| Last Updated: | May 28, 2010 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by Chang-Hua Hospital:
|
acupressure perimenopause menopause |
anxiety life quality insomnia |
Additional relevant MeSH terms:
|
Anxiety Disorders Sleep Initiation and Maintenance Disorders Mental Disorders Sleep Disorders, Intrinsic |
Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013