Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2025-12-25 @ 7:49 PM
Study NCT ID:
NCT04442035
Status:
COMPLETED
Last Update Posted:
2020-06-22
First Post:
2020-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
5-element Music Therapy on Patients With Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2018-06-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-19', 'studyFirstSubmitDate': '2020-06-17', 'studyFirstSubmitQcDate': '2020-06-19', 'lastUpdatePostDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Self-Rating Anxiety Scale (SAS) score at 3 Months', 'timeFrame': 'Baseline and months 3', 'description': 'The SAS is validated,self-reported table assessing anxiety state over the past 3 month.Possible scores below 50 defined as no anxiety,range 50 to 59 is Mild anxiety,range 60 to 69 is Moderate anxiety , scores above 70 is Severe Anxiety.The higher the score the worse state change=( months 3 score -Baseline score )'}, {'measure': 'Change From Baseline in Self-Rating Depression Scale(SDS) score at 3 Months', 'timeFrame': 'Baseline and months 3', 'description': 'The SDS is validated,self-reported table assessing depression state over the past 3 month.Possible scores below 52 defined as no anxiety,range 53 to 62 is Mild anxiety,range 63 to 72 is Moderate anxiety , scores above 73 is Severe Anxiety.The higher the score the worse state change=( months 3 score -Baseline score )'}, {'measure': 'Change From Baseline in Quality of Life (FACT-B score) at 3 Months', 'timeFrame': 'Baseline and months 3', 'description': "The FACT-B is validated,self-reported table assessing quality of life over the past 3 month. The scale evaluation breast cancer patient's quality of life for 5 - dimensional such as physiological, social\\&family, emotions ; status ; breast cancer additional entries .\n\nThe higher the score , the better state change=( months 3 score -Baseline score )"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer', 'music therapy', 'Quality of Life', 'Depression, Anxiety'], 'conditions': ['Breast Cancer Female', 'Quality of Life', 'Depression, Anxiety']}, 'descriptionModule': {'briefSummary': 'In this study, we observed the clinical effect of using music therapy of TCM to improve the status of liver depression in patients with postoperative breast cancer patients, Second we want to explore the efficacy and advantages of traditional Chinese medicine in patients with postoperative breast cancer, and to reveal the clinical use of the efficacy and superiority.', 'detailedDescription': "The study is a prospective controlled trial. Sixty-four patients were divided randomly into two groups. Patients were randomly divided into the treatment group and the control group, namely, the music treatment group and the health education group. The treatment group was given at least 30 minutes of individual music therapy and group music therapy every 3 weeks. Instead, the control group was given every 3 weeks of health education preach. It will take 12 weeks for treatment and observation. The efficacy was evaluated by observing the beginning and end of the trial of the Self-Rating Anxiety Scale score, the Self-Rating Depression Scale score, and the Breast Cancer Patients' Quality of Life Scale. At the end of the treatment, we take software packages SPSS 20.0 for management and statistical analysis."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '66 Years', 'minimumAge': '27 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the diagnosis of breast cancer in clinical stage (Ⅰ, Ⅱ, Ⅲ) and postoperative breast cancer during one month;\n* All participants had to have clinical depression and stagnation of liver qi;\n* age 27-66;\n* participants are conscious and willing to be followed up during the treatment.\n\nExclusion Criteria:\n\n* Metastasis of breast cancer or serious complications;\n* Patients with major depressive disorder;\n* The past medical history of mental disorders;\n* The primary diseases including liver, kidney, cerebrovascular, cardiovascular and hematopoietic system diseases;\n* Participating in another clinical study or undergoing another intervention;\n* Patients with hearing loss.'}, 'identificationModule': {'nctId': 'NCT04442035', 'briefTitle': '5-element Music Therapy on Patients With Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Guangzhou University of Traditional Chinese Medicine'}, 'officialTitle': 'Clinical Efficacy Study on 5-element Music Therapy on Patients With Physically and Psychologically Unbalance After Breast Cancer Surgery', 'orgStudyIdInfo': {'id': 'B2016-043-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The teatment group', 'description': '5-element misic therapy', 'interventionNames': ['Behavioral: 5-element music therapy']}, {'type': 'EXPERIMENTAL', 'label': 'The control group', 'description': 'health education', 'interventionNames': ['Behavioral: 5-element music therapy']}], 'interventions': [{'name': '5-element music therapy', 'type': 'BEHAVIORAL', 'otherNames': ['health education'], 'description': 'participants were treated by TCM five-phase music therapy for not less than 30 minutes per day, and group music therapy was performed every three weeks. In addition, the therapeutic schedule is composed of treatment time (1pm-2pm, 9pm-11pm), frequency treatment (two times a day), intervention (10-15 minutes in the afternoon, 30 minutes in the evening) and content (individuals: dialectical selection of music; groups: community singing, every three weeks).', 'armGroupLabels': ['The control group', 'The teatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangdong Provincial Chinese medicine hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Zheng zhuanfang', 'role': 'STUDY_CHAIR', 'affiliation': 'Second Clinical College of Guangzhou University of Traditional Chinese Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}