Auricular Acupressure for Perimenopausal Women With Anxiety

Anxiety Clinical Trial

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Official title:

Effect of Auricular Acupressure on Perimenopausal and Early Postmenopausal Women With Anxiety: a Double Blinded, Randomized and Controlled Study

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01056458
• Other study ID #: 98DMR291
• 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
• 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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Auricular Acupressure
• Insomnia
• Menopause
• Sleep Initiation and Maintenance Disorders

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