Auricular Acupressure for Perimenopausal Women With Anxiety

Study Overview
=================
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.

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

Conditions
-----------------
Auricular Acupressure, Anxiety, Menopause, Insomnia

Intervention / Treatment
-----------------
* Other: auricular acupressure
* Other: sham acupressure


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acupressure acupressure<br> | Other: auricular acupressure<br>* 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.<br>* Other names: acupressure;|
| Sham Comparator: sham acupressure<br> | Other: sham acupressure<br>* use only tape without ear adhesive beads under the same ways<br>* Other names: acupressure;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acupressure, perimenopause, menopause, anxiety, life quality, insomnia