Clinical trial NCT01056458: Auricular Acupressure for Perimenopausal Women With Anxiety
Official title: Effect of Auricular Acupressure on Perimenopausal and Early Postmenopausal Women With Anxiety: a Double Blinded, Randomized and Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Auricular Acupressure
Anxiety
Menopause
Insomnia
Keywords: acupressure
perimenopause
menopause
anxiety
life quality
insomnia
Lead sponsor: Chang-Hua Hospital
Sponsor class: OTHER_GOV
Collaborators: name: China Medical University Hospital
First posted: 2010-01-26
Enrollment: 90
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hamilton Anxiety Rating Scale
timeFrame: 4 weeks aftter ear acupressure
Secondary outcomes:
measure: Menopause Rating Scale,Short Form Health Survey(SF-36),CGI
timeFrame: 4 weeks aftter ear acupressure
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Chang-Hua Hospital
Study officials:
affiliation: Chang-Hua Hospital, Department of Health
name: Ching-Ling Kao, MD
role: PRINCIPAL_INVESTIGATOR
References: