Auricular Acupressure for Perimenopausal Women With Anxiety

Not Applicable

• Conditions: Auricular Acupressure; Anxiety; Menopause; Insomnia
• Interventions: Other: auricular acupressure; Other: sham acupressure

• Registration Number: NCT01056458
• Lead Sponsor: Chang-Hua Hospital

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.

Study Timeline

• Status Verified: 2010-01
• Study Start: 2010-01
• Study First Submitted: 2010-01-25
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-26
• Last Update Submitted: 2010-05-28
• Last Update Posted: 2010-05-31
• Primary Completion: 2011-01
• Study Completion: 2011-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Acupressure acupressure	auricular acupressure	-
sham acupressure	sham acupressure	-

Primary Outcome Measures

Name	Time	Method
Hamilton Anxiety Rating Scale	4 weeks aftter ear acupressure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chang-Hua Hospital; 🇨🇳 Changhua, Taiwan