NCT01056458

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

May 31, 2010

Status Verified

January 1, 2010

Enrollment Period

1 year

First QC Date

January 25, 2010

Last Update Submit

May 28, 2010

Conditions

Keywords

acupressureperimenopausemenopauseanxietylife qualityinsomnia

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 COMPARATOR
Other: auricular acupressure

sham acupressure

SHAM COMPARATOR
Other: sham acupressure

Interventions

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.

Also known as: acupressure
Acupressure acupressure

use only tape without ear adhesive beads under the same ways

Also known as: acupressure
sham acupressure

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Study Sites (1)

Chang-Hua Hospital

Changhua, 513, Taiwan

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersSleep Initiation and Maintenance Disorders

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Mental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Ching-Ling Kao, MD

    Chang-Hua Hospital, Department of Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ching-Ling Kao, MD

CONTACT

Ching-Liang Hsieh, MD,PhD

CONTACT

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

Locations