Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-03-09 @ 5:49 AM
Study NCT ID:
NCT02269527
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2014-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Live Music on the Perception of Noise in the SICU: A Patient, Caregiver, and Medical Staff Environmental Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-13', 'studyFirstSubmitDate': '2014-05-27', 'studyFirstSubmitQcDate': '2014-10-17', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-report stress level from SICU staff', 'timeFrame': '6 months', 'description': 'Environmental music therapy will reduce stress level for SICU staff.'}, {'measure': 'Pre and Post-intervention score on the perception of SICU noises from SICU and Hospital Anxiety and Depression Scale for SICU patients', 'timeFrame': '1 week', 'description': 'Environmental Music Therapy will ameliorate the perception of noises and decrease the anxiety level of SICU patients and caregivers'}, {'measure': 'Pre and Post-intervention score on the perception of SICU noises from SICU patients, caregivers', 'timeFrame': '1 week'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain', 'Anxiety', 'Stress']}, 'descriptionModule': {'briefSummary': "The use of live music in SICU might affect the perception of noise, which may reduce staff's stress level and further decrease the possibility of clinical errors, reduce patient's anxiety and perception of pain as well as increase compliance from patient and family. Live music might also enhance the quality of stay and promote a holistic healing process for the patient.", 'detailedDescription': "In this study, the research team is looking at the effect of the live music provided by a trained music therapist, created through incorporating the noises in the SICU - such as the beeping of the machines as part of the elements in the music, to organize the sound environment as well as introducing familiar songs, chosen according to the cultures and ages of the patients, caregivers and staff, to increase a sense of familiarity and comfort. Through the intervention, the research team hope to ameliorate the effects of a noxious sound environment, which may reduce the stress level of the staff and increase their acuity level while decrease patients and caregivers' anxiety level and improve their mood state and the quality of hospitalization"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* SICU patients, caregivers, and physicians/nursing staff\n\nExclusion Criteria:\n\n* Non-medical Staff'}, 'identificationModule': {'nctId': 'NCT02269527', 'briefTitle': 'Effects of Live Music on the Perception of Noise in the SICU: A Patient, Caregiver, and Medical Staff Environmental Study', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Effects of an Integrative Music Therapy Program on the Perception of Noise in the SICU: A Patient, Caregiver, and Physician/Nursing Environmental Study', 'orgStudyIdInfo': {'id': 'GCO 16-0936'}, 'secondaryIdInfos': [{'id': 'IRB 088-10', 'type': 'OTHER', 'domain': 'Beth Israel Medical Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Live music', 'description': '1-hour live music 5 days/week', 'interventionNames': ['Other: Live music']}], 'interventions': [{'name': 'Live music', 'type': 'OTHER', 'description': 'Providing 1-hour live music 5 days/ week.', 'armGroupLabels': ['Live music']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Beth Israel', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Joanne Loewy, DA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mount Sinai Union Square'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Clinical Professor', 'investigatorFullName': 'Joanne Loewy', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}