Ignite Creation Date:
2024-05-05 @ 10:12 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01056458
Status:
UNKNOWN
Last Update Posted:
2010-05-31
First Post:
2010-01-25
Brief Title:
Auricular Acupressure for Perimenopausal Women With Anxiety
Sponsor:
Chang-Hua Hospital
Organization:
Chang-Hua Hospital
Study Overview
Official Title:
Effect of Auricular Acupressure on Perimenopausal and Early Postmenopausal Women With Anxiety a Double Blinded Randomized and Controlled Study
Status:
UNKNOWN
Status Verified Date:
2010-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AAA
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 537 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None