Auricular Acupressure for Perimenopausal Women With Anxiety (AAA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Chang-Hua Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
China Medical University Hospital
Information provided by:
Chang-Hua Hospital
ClinicalTrials.gov Identifier:
NCT01056458
First received: January 25, 2010
Last updated: May 28, 2010
Last verified: January 2010
  Purpose

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 Intervention
Auricular Acupressure
Anxiety
Menopause
Insomnia
Other: auricular acupressure
Other: sham acupressure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Chang-Hua Hospital:

Primary Outcome Measures:
  • Hamilton Anxiety Rating Scale [ Time Frame: 4 weeks aftter ear acupressure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Menopause Rating Scale,Short Form Health Survey(SF-36),CGI [ Time Frame: 4 weeks aftter ear acupressure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: January 2010
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056458

Contacts
Contact: Ching-Ling Kao, MD 886-4-8298686 ext 1805 chinglingkao@gmail.com
Contact: Ching-Liang Hsieh, MD,PhD 886-4-22053366 ext 3609 clhsieh@mail.cmuh.org.tw

Locations
Taiwan
Chang-Hua Hospital Recruiting
Changhua, Taiwan, 513
Contact: Ching-Ling Kao , MD    4886-4-8298686 ext 1805    chinglingkao@gmail.com   
Principal Investigator: Ching-Ling Kao, MD         
Sponsors and Collaborators
Chang-Hua Hospital
China Medical University Hospital
Investigators
Principal Investigator: Ching-Ling Kao, MD Chang-Hua Hospital, Department of Health
  More Information

No publications provided

Responsible Party: Ching-Ling Kao, MD, Chang-Hua Hospital
ClinicalTrials.gov Identifier: NCT01056458     History of Changes
Other Study ID Numbers: 98DMR291
Study First Received: January 25, 2010
Last Updated: May 28, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by Chang-Hua Hospital:
acupressure
perimenopause
menopause
anxiety
life quality
insomnia

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014