Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-31 @ 3:02 PM
Study NCT ID:
NCT01056458
Status:
UNKNOWN
Last Update Posted:
2010-05-31
First Post:
2010-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Auricular Acupressure for Perimenopausal Women With Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-04-28', 'releaseDate': '2011-04-04'}, {'resetDate': '2011-06-13', 'releaseDate': '2011-05-13'}], 'estimatedResultsFirstSubmitDate': '2011-04-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019050', 'term': 'Acupressure'}], 'ancestors': [{'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-05-28', 'studyFirstSubmitDate': '2010-01-25', 'studyFirstSubmitQcDate': '2010-01-25', 'lastUpdatePostDateStruct': {'date': '2010-05-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Anxiety Rating Scale', 'timeFrame': '4 weeks aftter ear acupressure'}], 'secondaryOutcomes': [{'measure': 'Menopause Rating Scale,Short Form Health Survey(SF-36),CGI', 'timeFrame': '4 weeks aftter ear acupressure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acupressure', 'perimenopause', 'menopause', 'anxiety', 'life quality', 'insomnia'], 'conditions': ['Auricular Acupressure', 'Anxiety', 'Menopause', 'Insomnia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 40 to 60 years\n* irregular menstrual cycle less than 12 months or no menstrual cycle less than 10 years\n* FSH level\\>= 14 IU/L\n* Brief symptom rating scale total scores\\>= 6\n\nExclusion Criteria:\n\n* severe medical conditions\n* substance dependence or abuse\n* contraindication of BZDs\n* contraindication of acupressure\n* other primary anxiety disorder and major psychosis\n* use hormone therapy\n* use herb medicine'}, 'identificationModule': {'nctId': 'NCT01056458', 'acronym': 'AAA', 'briefTitle': 'Auricular Acupressure for Perimenopausal Women With Anxiety', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Chang-Hua Hospital'}, 'officialTitle': 'Effect of Auricular Acupressure on Perimenopausal and Early Postmenopausal Women With Anxiety: a Double Blinded, Randomized and Controlled Study', 'orgStudyIdInfo': {'id': '98DMR291'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Acupressure acupressure', 'interventionNames': ['Other: auricular acupressure']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham acupressure', 'interventionNames': ['Other: sham acupressure']}], 'interventions': [{'name': 'auricular acupressure', 'type': 'OTHER', 'otherNames': ['acupressure'], 'description': '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.', 'armGroupLabels': ['Acupressure acupressure']}, {'name': 'sham acupressure', 'type': 'OTHER', 'otherNames': ['acupressure'], 'description': 'use only tape without ear adhesive beads under the same ways', 'armGroupLabels': ['sham acupressure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '513', 'city': 'Changhua', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ching-Ling Kao, MD', 'role': 'CONTACT', 'email': 'chinglingkao@gmail.com', 'phone': '4886-4-8298686', 'phoneExt': '1805'}, {'name': 'Ching-Ling Kao, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chang-Hua Hospital', 'geoPoint': {'lat': 24.0692, 'lon': 120.5512}}], 'centralContacts': [{'name': 'Ching-Ling Kao, MD', 'role': 'CONTACT', 'email': 'chinglingkao@gmail.com', 'phone': '886-4-8298686', 'phoneExt': '1805'}, {'name': 'Ching-Liang Hsieh, MD,PhD', 'role': 'CONTACT', 'email': 'clhsieh@mail.cmuh.org.tw', 'phone': '886-4-22053366', 'phoneExt': '3609'}], 'overallOfficials': [{'name': 'Ching-Ling Kao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang-Hua Hospital, Department of Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang-Hua Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'China Medical University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Ching-Ling Kao, MD', 'oldOrganization': 'Chang-Hua Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-04-04', 'type': 'RELEASE'}, {'date': '2011-04-28', 'type': 'RESET'}, {'date': '2011-05-13', 'type': 'RELEASE'}, {'date': '2011-06-13', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Chang-Hua Hospital (Ching-Ling Kao, MD)'}}}}