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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT01056458
Other study ID # 98DMR291
Secondary ID
Status Unknown status
Phase N/A
First received January 25, 2010
Last updated May 28, 2010
Start date January 2010
Est. completion date January 2011

Study information

Verified date January 2010
Source Chang-Hua Hospital
Contact Ching-Ling Kao, MD
Phone 886-4-8298686
Email chinglingkao@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Unknown status
Enrollment 90
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
sham acupressure
use only tape without ear adhesive beads under the same ways

Locations

Country Name City State
Taiwan Chang-Hua Hospital Changhua

Sponsors (2)

Lead Sponsor Collaborator
Chang-Hua Hospital China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hamilton Anxiety Rating Scale 4 weeks aftter ear acupressure
Secondary Menopause Rating Scale,Short Form Health Survey(SF-36),CGI 4 weeks aftter ear acupressure
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