Auricular Acupressure for Perimenopausal Women With Anxiety
AAA
Effect of Auricular Acupressure on Perimenopausal and Early Postmenopausal Women With Anxiety: a Double Blinded, Randomized and Controlled Study
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 25, 2010
CompletedFirst Posted
Study publicly available on registry
January 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedMay 31, 2010
January 1, 2010
1 year
January 25, 2010
May 28, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hamilton Anxiety Rating Scale
4 weeks aftter ear acupressure
Secondary Outcomes (1)
Menopause Rating Scale,Short Form Health Survey(SF-36),CGI
4 weeks aftter ear acupressure
Study Arms (2)
Acupressure acupressure
ACTIVE COMPARATORsham acupressure
SHAM COMPARATORInterventions
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.
use only tape without ear adhesive beads under the same ways
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chang-Hua Hospitallead
- China Medical University Hospitalcollaborator
Study Sites (1)
Chang-Hua Hospital
Changhua, 513, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ching-Ling Kao, MD
Chang-Hua Hospital, Department of Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
January 25, 2010
First Posted
January 26, 2010
Study Start
January 1, 2010
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
May 31, 2010
Record last verified: 2010-01