Auricular Acupressure for Perimenopausal Women With Anxiety

NCT ID: NCT01056458

Last Updated: 2010-05-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-01-31

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.

Conditions

Auricular Acupressure; Anxiety; Menopause; Insomnia

Keywords

acupressure; perimenopause; menopause; anxiety; life quality; insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Acupressure acupressure

Group Type: ACTIVE_COMPARATOR

auricular acupressure

Intervention Type: OTHER

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

Group Type: SHAM_COMPARATOR

sham acupressure

Intervention Type: OTHER

use only tape without ear adhesive beads under the same ways

Interventions

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.

Intervention Type: OTHER

sham acupressure

use only tape without ear adhesive beads under the same ways

Intervention Type: OTHER

Other Intervention Names

acupressure; acupressure

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: collaborator

Chang-Hua Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Chang-Hua Hospital

Principal Investigators

Ching-Ling Kao, MD

Role: PRINCIPAL_INVESTIGATOR

Chang-Hua Hospital, Department of Health

Locations

Chang-Hua Hospital

Changhua, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ching-Ling Kao, MD

Role: CONTACT

Phone: 886-4-8298686

Email: chinglingkao@gmail.com

Ching-Liang Hsieh, MD,PhD

Role: CONTACT

Phone: 886-4-22053366

Email: clhsieh@mail.cmuh.org.tw

Facility Contacts

Ching-Ling Kao, MD

Role: primary

Other Identifiers

98DMR291

Identifier Type: -

Identifier Source: org_study_id