Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-02-22 @ 1:00 PM
Study NCT ID:
NCT03381820
Status:
COMPLETED
Last Update Posted:
2017-12-22
First Post:
2017-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Thai Northeastern Folk Musical Therapy for Blood Pressure Control in Hypertensive Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised control trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-20', 'studyFirstSubmitDate': '2017-12-18', 'studyFirstSubmitQcDate': '2017-12-20', 'lastUpdatePostDateStruct': {'date': '2017-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline of home systolic and diastolic blood pressure at day 30th', 'timeFrame': 'Day 0th (baseline) to day 30th.', 'description': 'Home blood pressure of participant was monitored and recorded.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline of office systolic and diastolic blood pressure at day 120th', 'timeFrame': 'Day 0th and day 120th', 'description': 'Office blood pressure was measured at day 0th (baseline) and at day 120th (3-month follow up).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['music therapy', 'hypertension', 'Asian', 'stage-2 hypertension'], 'conditions': ['Musical Therapy as a Complementary Treatment of Hypertension']}, 'referencesModule': {'references': [{'pmid': '30012391', 'type': 'DERIVED', 'citation': 'Im-Oun S, Kotruchin P, Thinsug P, Mitsungnern T, Techa-Atik P, Pongchaiyakul C. Effect of Thai instrumental folk music on blood pressure: A randomized controlled trial in stage-2 hypertensive patients. Complement Ther Med. 2018 Aug;39:43-48. doi: 10.1016/j.ctim.2018.05.014. Epub 2018 May 26.'}]}, 'descriptionModule': {'briefSummary': 'A randomized controlled trial was conducted in a tertiary care hospital, Khon Kaen province, Thailand. Sixty participants were randomized to music listening group and control group. The music listening group was assigned to listen to 30-minute instrumental folk music everyday for one month. Home BP and office BP were monitored and recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 40-80 years old\n* Diagnosed stage-2 hypertension (HT) (defined by office systolic blood pressure \\>= 140mm Hg and/or diastolic blood pressure \\>= 90 mm Hg at first hospital visit)\n\nExclusion Criteria:\n\n* Pregnant women, white-coat HT, secondary HT and hearing loss or blind.'}, 'identificationModule': {'nctId': 'NCT03381820', 'briefTitle': 'Effectiveness of Thai Northeastern Folk Musical Therapy for Blood Pressure Control in Hypertensive Patients', 'organization': {'class': 'OTHER', 'fullName': 'Khon Kaen University'}, 'officialTitle': 'Instrumental Folk Music Listening Reduced Home Blood Pressure in Stage-2 Hypertensive Patients; a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HE581320'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'music listening', 'description': 'Participants who were randomized into intervention group were assigned to listen to the music everyday (day 1st to day 30th), at anytime of day that was suitable with their lifestyles but not at the time of BP measurement. During day 31st -120th, participants did not listen to the music. Other treatment was the same as the control arm.', 'interventionNames': ['Other: instrumental folk music']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'control arm received conventional hypertension treatment.'}], 'interventions': [{'name': 'instrumental folk music', 'type': 'OTHER', 'description': 'The music was composed and edited by a professor of Folk Musical Department, Faculty of Arts, Khon Kaen University. There were total of 6 songs, 32-minute length. The music was slow-instrumental, 60-80 beats per minute and ranged between 40-60 decibel levels.', 'armGroupLabels': ['music listening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40002', 'city': 'Khon Kaen', 'state': 'Muang', 'country': 'Thailand', 'facility': 'Emergency Medicine, Khon Kaen University', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data is available when contact and request to the correspondence author or principal investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Khon Kaen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Praew Kotruchin', 'investigatorAffiliation': 'Khon Kaen University'}}}}