Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-01-26 @ 11:25 PM
Study NCT ID:
NCT03156192
Status:
COMPLETED
Last Update Posted:
2017-11-14
First Post:
2017-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Music Use and Perceived Psycho-social Benefits of Music of Caregivers of Patients in an Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-09', 'studyFirstSubmitDate': '2017-05-15', 'studyFirstSubmitQcDate': '2017-05-16', 'lastUpdatePostDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Beck Depression Index', 'timeFrame': 'a single point in time obtaining the questionnaire (1 day)'}, {'measure': 'quality of Life questionnaire', 'timeFrame': 'a single point in time obtaining the questionnaire (1 day)'}, {'measure': 'self-reported music use and perceived benefits of music questionnaire', 'timeFrame': 'a single point in time obtaining the questionnaire (1 day)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Caregivers', 'Family-centered care', 'Music use', 'Psycho-social benefits of music'], 'conditions': ['Caregivers of ICU Patients']}, 'referencesModule': {'references': [{'pmid': '15840894', 'type': 'BACKGROUND', 'citation': "Auerbach SM, Kiesler DJ, Wartella J, Rausch S, Ward KR, Ivatury R. Optimism, satisfaction with needs met, interpersonal perceptions of the healthcare team, and emotional distress in patients' family members during critical care hospitalization. Am J Crit Care. 2005 May;14(3):202-10."}, {'pmid': '15665319', 'type': 'BACKGROUND', 'citation': 'Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, Annane D, Bleichner G, Bollaert PE, Darmon M, Fassier T, Galliot R, Garrouste-Orgeas M, Goulenok C, Goldgran-Toledano D, Hayon J, Jourdain M, Kaidomar M, Laplace C, Larche J, Liotier J, Papazian L, Poisson C, Reignier J, Saidi F, Schlemmer B; FAMIREA Study Group. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med. 2005 May 1;171(9):987-94. doi: 10.1164/rccm.200409-1295OC. Epub 2005 Jan 21.'}, {'pmid': '19487778', 'type': 'BACKGROUND', 'citation': "Davidson JE. Family-centered care: meeting the needs of patients' families and helping families adapt to critical illness. Crit Care Nurse. 2009 Jun;29(3):28-34; quiz 35. doi: 10.4037/ccn2009611. No abstract available."}, {'pmid': '16183062', 'type': 'BACKGROUND', 'citation': 'Chien WT, Chiu YL, Lam LW, Ip WY. Effects of a needs-based education programme for family carers with a relative in an intensive care unit: a quasi-experimental study. Int J Nurs Stud. 2006 Jan;43(1):39-50. doi: 10.1016/j.ijnurstu.2005.01.006. Epub 2005 Sep 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate how family caregivers of ICU patients perceive their psycho-social needs and quality of life, how they use music in their everyday life and perceive music as beneficial to themselves. Participants are adult family members of critically ill patients in ICU. After obtaining the informed consent form, a questionnaire will be distributed to each participant.', 'detailedDescription': 'The purpose of this study is to investigate how family caregivers of ICU patients perceive their psycho-social needs and quality of life, how they use music in their everyday life and perceive music as beneficial to themselves. Participants are adult family members of critically ill patients in ICU. After obtaining the informed consent form, a questionnaire will be distributed to each participant. The questionnaire consists of Beck Depression Index, Quality of Life scale, and the self-reported items on music use in everyday lives and perceived benefits of music. Based on the completed measures, how caregivers of ICU patients use music and perceive music as beneficial media for their psycho-social health will be analyzed in relation to demographic information and the current level of depression and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary caregivers (family members) of ICU patients\n* aged over 20\n\nExclusion Criteria:\n\n* the one who have difficulties in verbal communication due to the history of psychiatric illness or cognitive impairment (e.g., dementia)'}, 'identificationModule': {'nctId': 'NCT03156192', 'briefTitle': 'Music Use and Perceived Psycho-social Benefits of Music of Caregivers of Patients in an Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Music Use and Perceived Psycho-social Benefits of Music of Caregivers of Patients in an Intensive Care Unit', 'orgStudyIdInfo': {'id': '4-2016-1028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Caregivers of ICU patients', 'description': 'Caregivers (family member) aged over 20 who provides care to ICU patients', 'interventionNames': ['Behavioral: Survey']}], 'interventions': [{'name': 'Survey', 'type': 'BEHAVIORAL', 'description': 'Survey on the level of depression, quality of life, current and past music experiences, and perceived benefits of music in relation to psycho-social needs', 'armGroupLabels': ['Caregivers of ICU patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}