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Auricular Acupressure for Perimenopausal Women With Anxiety (AAA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01056458
Recruitment Status : Unknown
Verified January 2010 by Chang-Hua Hospital.
Recruitment status was:  Recruiting
First Posted : January 26, 2010
Last Update Posted : May 31, 2010
China Medical University Hospital
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Auricular Acupressure Anxiety Menopause Insomnia Other: auricular acupressure Other: sham acupressure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Auricular Acupressure on Perimenopausal and Early Postmenopausal Women With Anxiety: a Double Blinded, Randomized and Controlled Study
Study Start Date : January 2010
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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 Name: acupressure

Sham Comparator: sham acupressure Other: sham acupressure
use only tape without ear adhesive beads under the same ways
Other Name: acupressure

Primary Outcome Measures :
  1. Hamilton Anxiety Rating Scale [ Time Frame: 4 weeks aftter ear acupressure ]

Secondary Outcome Measures :
  1. Menopause Rating Scale,Short Form Health Survey(SF-36),CGI [ Time Frame: 4 weeks aftter ear acupressure ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01056458

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Contact: Ching-Ling Kao, MD 886-4-8298686 ext 1805
Contact: Ching-Liang Hsieh, MD,PhD 886-4-22053366 ext 3609

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Chang-Hua Hospital Recruiting
Changhua, Taiwan, 513
Contact: Ching-Ling Kao, MD    4886-4-8298686 ext 1805   
Principal Investigator: Ching-Ling Kao, MD         
Sponsors and Collaborators
Chang-Hua Hospital
China Medical University Hospital
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Principal Investigator: Ching-Ling Kao, MD Chang-Hua Hospital, Department of Health
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Responsible Party: Ching-Ling Kao, MD, Chang-Hua Hospital Identifier: NCT01056458    
Other Study ID Numbers: 98DMR291
First Posted: January 26, 2010    Key Record Dates
Last Update Posted: May 31, 2010
Last Verified: January 2010
Keywords provided by Chang-Hua Hospital:
life quality
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Anxiety Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases