Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-02-22 @ 12:23 PM
Study NCT ID:
NCT03916835
Status:
COMPLETED
Last Update Posted:
2021-12-23
First Post:
2019-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MUSIDORE PED Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'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': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009147', 'term': 'Music Therapy'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-22', 'studyFirstSubmitDate': '2019-04-04', 'studyFirstSubmitQcDate': '2019-04-12', 'lastUpdatePostDateStruct': {'date': '2021-12-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The FLACC (Face Legs Activity Cry Consolability) scale's score", 'timeFrame': 'Day 1 : 10 minutes before the care', 'description': 'The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.'}, {'measure': "The FLACC (Face Legs Activity Cry Consolability) scale's score", 'timeFrame': 'Day 1: During the care', 'description': 'The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.'}, {'measure': "The FLACC (Face Legs Activity Cry Consolability) scale's score", 'timeFrame': 'Day 2: 10 minutes before the care', 'description': 'The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.'}, {'measure': "The FLACC (Face Legs Activity Cry Consolability) scale's score", 'timeFrame': 'Day 2: During the care', 'description': 'The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.'}], 'secondaryOutcomes': [{'measure': 'Cardiac frequency', 'timeFrame': 'Day 1 : 10 minutes before the care', 'description': 'Values found on a device'}, {'measure': 'Cardiac frequency', 'timeFrame': 'Day 1 : During the care', 'description': 'Values found on a device'}, {'measure': 'Cardiac frequency', 'timeFrame': 'Day 2 : 10 minutes before the care', 'description': 'Values found on a device'}, {'measure': 'Cardiac frequency', 'timeFrame': 'Day 2 : During the care', 'description': 'Values found on a device'}, {'measure': 'breathing frequency', 'timeFrame': 'Day 1: 10 minutes before the care', 'description': 'Values found on a device'}, {'measure': 'breathing frequency', 'timeFrame': 'Day 1: During the care', 'description': 'Values found on a device'}, {'measure': 'breathing frequency', 'timeFrame': 'Day 2: 10 minutes before the care', 'description': 'Values found on a device'}, {'measure': 'breathing frequency', 'timeFrame': 'Day 2: During the care', 'description': 'Values found on a device'}, {'measure': 'Mean arterial pressure', 'timeFrame': 'Day 1: 10 minutes before the care', 'description': 'Values found on a device'}, {'measure': 'Mean arterial pressure', 'timeFrame': 'Day 1: During the care', 'description': 'Values found on a device'}, {'measure': 'Mean arterial pressure', 'timeFrame': 'Day 2: 10 minutes before the care', 'description': 'Values found on a device'}, {'measure': 'Mean arterial pressure', 'timeFrame': 'Day 2: During the care', 'description': 'Values found on a device'}, {'measure': 'Duration care', 'timeFrame': 'Day 1', 'description': 'Time management during cleaning cares'}, {'measure': 'Duration care', 'timeFrame': 'Day 2', 'description': 'Time management during cleaning cares'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric Critical ill care or intensive care', 'anxiety', 'pain'], 'conditions': ['Pain Management', 'Music Therapy']}, 'referencesModule': {'references': [{'pmid': '37722559', 'type': 'DERIVED', 'citation': 'Mounier S, Cambonie G, Baleine J, Le Roux M, Bringuier S, Milesi C. Music Therapy During Basic Daily Care in Critically Ill Children: A Randomized Crossover Clinical Trial. J Pediatr. 2024 Jan;264:113736. doi: 10.1016/j.jpeds.2023.113736. Epub 2023 Sep 16.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to measure the efficacy of music during a painful procedure in pediatric intensive care unit.\n\nMusic therapy has real effects on the pain level already proven in adults units. Our objective is to apply this technic to children. The investigators will evaluate this technic during cleaning care which is daily procedure for each stable patient and wich may be painful in this population.', 'detailedDescription': 'Pediatric intensive care units may be anxious places. A lot of painful and stressful procedures are done every day. A simple care such as a simple cleaning care may become painful or uncomfortable.\n\nUsually those situation require the use of painkillers. For several years, new approaches are used in order to decrease the pain level without medication such as hypnosis or music therapy. Music therapy proved efficacy to reduce pain in different procedures and is currently used in adult intensive care units in order to decrease anxiety and pain.\n\nOne specific program, "Music Care" is based on a "U sequence" which use tempo and rhythm variations following the U scheme, to relax patients.\n\nThis program will be evaluated in our department and the investigators will study the effects on the pain level during a cleaning care .\n\nThe patients will be evaluated during two consecutive cleaning cares. One with and the other without music therapy. The investigators will compare the variation of the FLACC scores (before and during cleaning care ) to show a difference between both methods. The order (with or without) will be randomized. The patient will be his one control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants between 6 months and 15 years old\n* Vigil child\n* Admitted to the department of Pediatric Critical Ill Unit at University Hospital in Montpellier (France)\n* Signed both parental consent.\n* Signed both parental authorization for videotape recording\n* Parents or person with legal authority who speaks and understands french\n\nExclusion Criteria:\n\n* Deaf child\n* Refusal of the child to participate in the study'}, 'identificationModule': {'nctId': 'NCT03916835', 'acronym': 'MUSIDORE', 'briefTitle': 'MUSIDORE PED Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Pain Management Via Music Therapy During Cleaning Cares in Pediatric Intensive Care Unit', 'orgStudyIdInfo': {'id': 'UF 7654'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Music Therapy during cleaning care 1', 'description': 'This group receives music therapy during cleaning care 1 and not during the cleaning care 2.\n\nEach patient will act as their own control', 'interventionNames': ['Device: Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy.']}, {'type': 'OTHER', 'label': 'Music Therapy during cleaning care 2', 'description': 'This group receives music therapy during cleaning care 2 and not during the cleaning care 1.\n\nEach patient will act as their own control', 'interventionNames': ['Device: Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy.']}], 'interventions': [{'name': 'Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy.', 'type': 'DEVICE', 'description': 'Each child will benefit two cleaning cares during hospitalization. One with music therapy and the other without music therapy.\n\nEvery time, the preparation will be the same with an equipment installation in order to keep comparability and blind.\n\nChild will be videotaped without sound during the care. The order of music therapy intervention will be randomized.', 'armGroupLabels': ['Music Therapy during cleaning care 1', 'Music Therapy during cleaning care 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34090', 'city': 'Montpellier', 'country': 'France', 'facility': 'Hopital Arnaud de Villeneuve- CHU Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}