Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT06848218
Status:
RECRUITING
Last Update Posted:
2025-07-01
First Post:
2025-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Music Therapy During NIV Implantation in Pediatric Intensive Care Units
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'the primary endpoint (FLACC Score) will be assessed on patient videos taken during NIV initiation. Thus, 2 FLACC score assessors will be blinded to the randomization arm'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, single-center, randomized controlled study, with blinded assessment of primary endpoint.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2025-01-23', 'studyFirstSubmitQcDate': '2025-02-21', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain variation before and during non invasive ventilation setting with and without music therapy.', 'timeFrame': 'assessment for 10 minutes before NIV start-up and for 10 minutes during NIV installation', 'description': "FLACC (Face Legs Activity Cry Consolability) : The main assessment tool is a simple, rapid behavioral pain assessment scale, commonly used in the pediatric intensive care unit.\n\nFor each item, 3 possible scores: 0 or 1 or 2; the total score is from 0 (no pain) to 10 (severe pain).\n\nThe primary outcome is variation of the Face Legs Activity Cry Consolability (FLACC) score (range, 0-10) comparing before and during non invasive ventilation setting.\n\nThe first FLACC score evaluation will be just before the beginning of music. The Second FLACC score evaluation will be during the non invasive ventilation setting.\n\nFLACC score evaluation over a 10-minute period, with selection of the highest score for each item during the evaluation period FLACC scores' evaluation will be done from videotape records without by 2 investigators The FLACC score will be determined blindly by two assessors who did not participate in the care, using the video taken when the NIV was set up."}], 'secondaryOutcomes': [{'measure': 'Pain variation during and after non invasive ventilation setting with and without music therapy. the highest score for each parameter will be selected for each evaluation period of 10 minutes', 'timeFrame': 'assessment for 10 minutes during NIV installation and for 10 minutes after NIV start-up', 'description': "FLACC (Face Legs Activity Cry Consolability) : The main assessment tool is a simple, rapid behavioral pain assessment scale, commonly used in the pediatric intensive care unit.\n\nFor each item, 3 possible scores: 0 or 1 or 2; the total score is from 0 (no pain) to 10 (severe pain).\n\nThe primary outcome is variation of the Face Legs Activity Cry Consolability (FLACC) score (range, 0-10) comparing before and during non invasive ventilation setting.\n\nThe first FLACC score evaluation will be just before the beginning of music. The Second FLACC score evaluation will be during the non invasive ventilation setting.\n\nFLACC scores' evaluation will be done from videotape records without by 2 investigators\n\nThe FLACC score will be determined blindly by two assessors who did not participate in the care, using the video taken when the NIV was set up."}, {'measure': 'Physiological data variations between the 2 groups: HR', 'timeFrame': 'assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up', 'description': 'An initial reading will be taken 10 minutes before NIV start-up, during start-up and 10 minutes afterwards.\n\nHR: heart rate in beats per minute the highest score for each parameter will be selected for each evaluation period of 10 minutes'}, {'measure': 'Physiological data variations between the 2 groups: FR', 'timeFrame': 'assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up', 'description': 'An initial reading will be taken 10 minutes before NIV start-up, during start-up and 10 minutes afterwards.\n\nFR: respiratory rate in inhalations per minute the highest score for each parameter will be selected for each evaluation period of 10 minutes'}, {'measure': 'Physiological data variations between the 2 groups: SBP', 'timeFrame': 'assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up', 'description': 'An initial reading will be taken 10 minutes before NIV start-up, during start-up and 10 minutes afterwards.\n\nSBP: systolic blood pressure in millimeters of mercury mmHg the highest score for each parameter will be selected for each evaluation period of 10 minutes'}, {'measure': 'Physiological data variations between the 2 groups: MAP', 'timeFrame': 'assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up', 'description': 'An initial reading will be taken 10 minutes before NIV start-up, during start-up and 10 minutes afterwards.\n\nMAP: mean arterial pressure in millimetres of mercury mmHg the highest score for each parameter will be selected for each evaluation period of 10 minutes'}, {'measure': 'Physiological data variations between the 2 groups: SpO2', 'timeFrame': 'assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up', 'description': 'An initial reading will be taken 10 minutes before NIV start-up, during start-up and 10 minutes afterwards.\n\nSpO² : blood oxygen saturation in percent the highest score for each parameter will be selected for each evaluation period of 10 minutes'}, {'measure': 'Physiological data variations between the 2 groups: FiO2.', 'timeFrame': 'assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up', 'description': 'An initial reading will be taken 10 minutes before NIV start-up, during start-up and 10 minutes afterwards.\n\nFiO2: fraction of inspired oxygen in percent the highest score for each parameter will be selected for each evaluation period of 10 minutes'}, {'measure': 'NIV set-up time between groups', 'timeFrame': 'from initiation to completion of NIV installation', 'description': 'time from initiation to completion of NIV installation in minutes'}, {'measure': 'Total NIV duration between groups', 'timeFrame': 'From initiation of the first NIV to the date of death or discharge from hospital, or up to 1 month after initiation of the NIV at the most', 'description': 'in hours'}, {'measure': 'Failure to implement NIV between groups', 'timeFrame': 'From initiation of the first NIV to the date of death or discharge from hospital, or up to 1 month after initiation of the NIV at the most', 'description': 'in raw numbers'}, {'measure': 'Use of sedative or anxiolytic drugs during NIV implantation between groups', 'timeFrame': 'from initiation to completion of NIV installation', 'description': 'dose in μg/kg/h'}, {'measure': 'Length of stay in intensive care between groups', 'timeFrame': 'from the date of admission in intensive care until discharge, or up to 1 month after initiation of NIV', 'description': 'in days'}, {'measure': 'total length of hospital stay between groups', 'timeFrame': 'from the date of admission to hospital until discharge, or up to 1 month after initiation of NIV', 'description': 'in days'}, {'measure': 'comparison of the number of NIV-related complications between the 2 groups', 'timeFrame': 'from the date of admission to hospital until discharge, or up to 1 month after initiation of NIV', 'description': 'Number of Complications of NIV, e.g. pneumothorax, decreased cardiac output (hypotension), gastric and abdominal distension, inhalation, nose, face and scalp pressure points, non-compliance, eye irritation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Music Therapy', 'Non invasive Ventilation', 'Pediatric intensive care unit', 'Pain', 'Comfort'], 'conditions': ['Acute Respiratory Failure (ARF)', 'Non Invasive Ventilation (NIV)']}, 'descriptionModule': {'briefSummary': "Non-invasive ventilation makes it possible to avoid intubation and improve patients' quality of life. However, pain is associated with discomfort and could lead to failure of this technique.\n\nThe aim of this study is to measure the effectiveness of music therapy on pain levels during non-invasive ventilation in critically ill children.\n\nTo this end, a pain score (Face Legs Activity Cry Consolability FLACC) will be assessed by raters blinded to the randomization arm during NIV initiation.\n\nThe FLACC score will be compared before and during implementation of NIV between two groups: a control group (without music therapy) and an experimental group (with music therapy).", 'detailedDescription': 'Patient admitted to a Pediatric Intensive Care Unit are exposed to moderate to severe pain due to disease severity and invasive treatment or procedures.\n\nNon invasive ventilation is an essential support in the treatment of infants and children with acute respiratory failure. Acceptance and tolerance are the keys to its success.\n\nComfort management, including pain management, is most often achieved through the administration of analgesic and/or sedative drugs (analgesics, anti-inflammatories, anxiolytics, hypnotics). However, these therapies, although effective, are not without risks, including potentially serious adverse effects (excessive sedation, prolonged hospitalization and ventilation, tolerance phenomena, withdrawal syndrome, delirium, constipation, etc.). These undesirable effects and their deleterious consequences prompt a more comprehensive approach to patient management, optimizing therapeutic strategies with the common aim of improving patient comfort and pain relief. One 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 the pediatric intensive care department and the investigators will study the effects on the pain level during a non invasive ventilation setting for children with respiratory failure.\n\nthe investigators will compare the variation of the FLACC scores (before and during nopn invasive ventilation setting) to show a difference between both methods. The order (with or without) will be randomized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Target population : Children aged 0 to 17, hospitalized in the pediatric intensive care unit for respiratory failure with indication for NIV.\n\nInclusion Criteria:\n\n* Children aged 0 to 17 inclusive\n* Children hospitalized in pediatric intensive care unit\n* Indication for NIV\n\nExclusion Criteria:\n\n* \\- Severe deafness\n* Clinical condition requiring immediate initiation of NIV\n* Refusal to allow the child to be photographed\n* Child not assessable by FLACC score (paralysis of lower limbs, etc.)\n* Child already receiving NIV respiratory support at home\n* Participation in other ongoing research involving the human person at major risk and constraint (RIPH category 1) or a drug trial according to European regulation 536/2014.\n* Absence of affiliation to a French social security scheme or beneficiary of such a scheme.\n* Subject deprived of liberty (art.L. 1121-6 du CSP)\n* Failure to obtain free and informed written or oral consent and authorization to take photographs from both parents (or from a single parent if the patient is accompanied by only one parent, in accordance with article 1122-2 of the French Public Health Code) or from the legal guardian and/or child.'}, 'identificationModule': {'nctId': 'NCT06848218', 'acronym': 'MusiNIV', 'briefTitle': 'Music Therapy During NIV Implantation in Pediatric Intensive Care Units', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Music Therapy During NIV Implantation in Pediatric Intensive Care Units', 'orgStudyIdInfo': {'id': 'RECHMPL23_0191'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Non invasive ventilation setting with Music Therapy', 'description': 'Each child will benefit non invasive ventilation setting for acute respiratory distress.\n\nIn this group, it will be with Music Therapy. Every time, the preparation will be the same with equipment installation with headphones for music listening, in order to keep comparability and blind for the evaluation. Sound will be activated in this group.\n\nEach child will be videotaped during the non invasive ventilation setting.', 'interventionNames': ['Other: Music Therapy', 'Procedure: Setting Up NIV']}, {'type': 'SHAM_COMPARATOR', 'label': 'Non invasive ventilation setting without Music Therapy', 'description': 'Each child will benefit Non invasive ventilation setting for acute respiratory distress.\n\nIn this group, it will be without Music therapy. Every time, the preparation will be the same with equipment installation with headphones for music listening, in order to keep comparability and blind for the evaluation. Sound will not be activated in this group.\n\nEach child will be videotaped during the non invasive ventilation setting.', 'interventionNames': ['Procedure: Setting Up NIV']}], 'interventions': [{'name': 'Music Therapy', 'type': 'OTHER', 'description': "This procedure is carried out using headphones installed in the child's ears. The music will be activated if the child is in the Music group, and will not be activated but present if the child is not in the Music group.\n\nNIV implementation will begin after 10 min of listening. The listening period will continue until the nadir period (when the music is slowest, for maximum relaxation), until 10 min after the start of the NIV.", 'armGroupLabels': ['Non invasive ventilation setting with Music Therapy']}, {'name': 'Setting Up NIV', 'type': 'PROCEDURE', 'description': "Non invasive ventilation is set up in several stages, with the help of at least two caregivers. The patient will be placed in a half-seated position or seated. Installation begins with the placement of the non invasive ventilation mask harness around the child's head, followed by the application of the mask to the face, held by a caregiver. Once the mask has been applied, ventilation is started by connecting the non invasive ventilation circuit to the mask. The harness is then tightened by the second caregiver.", 'armGroupLabels': ['Non invasive ventilation setting with Music Therapy', 'Non invasive ventilation setting without Music Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34090', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'role': 'CONTACT', 'email': 's-mounier@chu-montpellier.fr'}], 'facility': 'CHU de MONTPELLIER', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'Sophie MOUNIER, MD', 'role': 'CONTACT', 'email': 's-mounier@chu-montpellier.fr', 'phone': '04 67 33 66 09', 'phoneExt': '+33'}, {'name': 'Christophe MILESI, MD', 'role': 'CONTACT', 'email': 'c-milesi@chu-montpellier.fr', 'phone': '04 67 336158', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}