Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-26 @ 3:17 AM
Study NCT ID:
NCT03156205
Status:
COMPLETED
Last Update Posted:
2017-11-14
First Post:
2017-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Patient-Directed Interactive Music Therapy on Sleep, Delirium and Melatonin Levels is Critically Ill Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-09', 'studyFirstSubmitDate': '2017-05-15', 'studyFirstSubmitQcDate': '2017-05-15', 'lastUpdatePostDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Richards-Campbell Sleep Questionnaire (RCSQ)', 'timeFrame': 'RCSQ will be measured for 3 days. (once/day)', 'description': 'This scale evaluates sleep quality including perceptions of depth of sleep, sleep onset latency, number of awakenings, etc. It was designed as an outcome measure for assessment of the perception of sleep in critically ill patients.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['critically ill patients', 'music therapy', 'sleep', 'delirium', 'melatonin', 'elderly'], 'conditions': ['Critically Ill Adult Patients in Intensive Care Units']}, 'referencesModule': {'references': [{'pmid': '33117015', 'type': 'DERIVED', 'citation': 'Kim J, Choi D, Yeo MS, Yoo GE, Kim SJ, Na S. Effects of Patient-Directed Interactive Music Therapy on Sleep Quality in Postoperative Elderly Patients: A Randomized-Controlled Trial. Nat Sci Sleep. 2020 Oct 21;12:791-800. doi: 10.2147/NSS.S286375. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': '(Background) Adults in intensive care units (ICU), especially elderly patients often suffer from a lack of sleep or frequent sleep disruptions due to physical, emotional stress such as pain, inflammation, and anxiety. Delirium, acute cognitive dysfunction, which result from sleep deprivation often leads to prolonged ICU stay and increase medical costs. Pharmacological and non-pharmacological interventions have been tried to improve the duration and quality of sleep and to maintain diurnal cycle. (Purpose) The aim of this study is to assess the efficacy of patient-driven interactive music intervention on sleep promotion in critically ill elderly adults. Delirium and urine/blood melatonin level will be assessed, too. In this study, randomized controlled trial for 50 elderly ICU patients who aged over 65 years in each group will be proceeded.', 'detailedDescription': 'Background: Adults in intensive care units (ICU), especially elderly patients often suffer from a lack of sleep or frequent sleep disruptions due to physical, emotional stress such as pain, inflammation, and anxiety. Delirium, acute cognitive dysfunction, which result from sleep deprivation often leads to prolonged ICU stay and increase medical costs. Pharmacological and non-pharmacological interventions have been tried to improve the duration and quality of sleep and to maintain diurnal cycle.\n\nPurpose: The aim of this study is to assess the efficacy of patient-driven interactive music intervention on sleep promotion in critically ill elderly adults. Delirium and urine/blood melatonin level will be assessed, too. In this study, randomized controlled trial for 50 elderly ICU patients who aged over 65 years in each group will be proceeded.\n\nPrimary outcome: Richards-Campbell Sleep Questionnaire\n\nSecondary outcome: Confusion Assessment Method - ICU, blood/urine melatonin level, ICU stay, Hospital stay, and mechanical ventilation duration / Delirium, acute cognitive dysfunction, which result from sleep deprivation often leads to prolonged ICU stay and increase medical costs. Elderly patients in ICU often suffer from a lack of sleep or frequent sleep disruptions due to physical, emotional stress such as pain, inflammation, and anxiety. Pharmacological and non-pharmacological interventions have been tried to improve the duration and quality of sleep and to maintain diurnal cycle. If interactive music therapy could improve quality of sleep and reduce incidence and severity of delirium in this patient population, it will be a good way to reduce medical costs without significant complications.\n\nExpectation: There have been many trials to reduce delirium incidence and recover sleep patterns in ICU patients. If we could find interactive music therapy improve quality of sleep and reduce incidence and severity of delirium in this patient population, it will be a good way to reduce medical costs without significant complications. In addition, rhythm in music can be a appropriate support for respiration and motor function in elderly ICU patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ICU patients aged over 65\n* ASA(american society of anesthesiologists) class I-III\n\nExclusion Criteria:\n\n* patients who had difficulties in communication\n* history of neurological or psychiatric disorders, dementia, or alcohol use disorder.\n* emergency surgery'}, 'identificationModule': {'nctId': 'NCT03156205', 'briefTitle': 'Effects of Patient-Directed Interactive Music Therapy on Sleep, Delirium and Melatonin Levels is Critically Ill Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Effects of Patient-Directed Interactive Music Therapy on Sleep, Delirium and Melatonin Levels is Critically Ill Elderly Patients', 'orgStudyIdInfo': {'id': '4-2016-0873'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interactive Music Therapy', 'interventionNames': ['Behavioral: interactive music therapy']}, {'type': 'OTHER', 'label': 'passive music listening', 'interventionNames': ['Behavioral: passive music listening']}, {'type': 'OTHER', 'label': 'passive earphone-use', 'interventionNames': ['Behavioral: passive earphone-use']}], 'interventions': [{'name': 'interactive music therapy', 'type': 'BEHAVIORAL', 'description': 'For the interactive music therapy intervention group, each patient received individual interactive music therapy sessions administered by professional music therapists during daytime; the patient participated in listening to music predetermined based on his/her preference during night time.', 'armGroupLabels': ['Interactive Music Therapy']}, {'name': 'passive music listening', 'type': 'BEHAVIORAL', 'description': 'For the passive music listening group, each patient participated in music listening during night time without involving in interactive music therapy sessions during daytime.', 'armGroupLabels': ['passive music listening']}, {'name': 'passive earphone-use', 'type': 'BEHAVIORAL', 'description': 'For the passive earphone use group (control group), each participant used headphone and eye mask without music listening at night time.', 'armGroupLabels': ['passive earphone-use']}]}, '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'}}}}