Auricular Acupressure for Perimenopausal Women With Anxiety (AAA)

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

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.

Study Overview

• Status: Unknown
• Conditions: Insomnia; Anxiety; Menopause; Auricular Acupressure
• Intervention / Treatment: Other: auricular acupressure; Other: sham 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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ching-Ling Kao, MD; Phone Number: 1805 886-4-8298686; Email: chinglingkao@gmail.com
• Study Contact Backup: Name: Ching-Liang Hsieh, MD,PhD; Phone Number: 3609 886-4-22053366; Email: clhsieh@mail.cmuh.org.tw

Study Locations

• Taiwan
  • Changhua, Taiwan, 513
    • Recruiting
    • Chang-Hua Hospital
    • Contact: Ching-Ling Kao, MD; Phone Number: 1805 4886-4-8298686; Email: chinglingkao@gmail.com
    • Principal Investigator: Ching-Ling Kao, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: acupressure
Sham Comparator: sham acupressure	Other: sham acupressure; use only tape without ear adhesive beads under the same ways; Other Names: acupressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hamilton Anxiety Rating Scale	4 weeks aftter ear acupressure

Secondary Outcome Measures

Outcome Measure	Time Frame
Menopause Rating Scale,Short Form Health Survey(SF-36),CGI	4 weeks aftter ear acupressure

Collaborators and Investigators

• Sponsor: Chang-Hua Hospital
• Collaborators: China Medical University Hospital
• Investigators: Principal Investigator: Ching-Ling Kao, MD, Chang-Hua Hospital, Department of Health

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): January 1, 2011
• Study Completion (Anticipated): January 1, 2011

Study Registration Dates

• First Submitted: January 25, 2010
• First Submitted That Met QC Criteria: January 25, 2010
• First Posted (Estimate): January 26, 2010

Study Record Updates

• Last Update Posted (Estimate): May 31, 2010
• Last Update Submitted That Met QC Criteria: May 28, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: menopause; insomnia; anxiety; life quality; acupressure; perimenopause
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Anxiety Disorders
• Other Study ID Numbers: 98DMR291