[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581277":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":31,"locations":42,"responsibleParty":58,"collaborators":25,"id":60,"slug":25,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":25,"maxAge":67,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"University Hospital, Montpellier","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Non invasive ventilation setting with Music Therapy","EXPERIMENTAL","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.",[13,14],"Other: Music Therapy","Procedure: Setting Up NIV",{"label":16,"type":17,"description":18,"interventionNames":19},"Non invasive ventilation setting without Music Therapy","SHAM_COMPARATOR","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.",[14],[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Music Therapy","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.",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"PROCEDURE","Setting Up NIV","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.",[9,16],[32,38],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Sophie MOUNIER, MD","CONTACT","04 67 33 66 09","+33","s-mounier@chu-montpellier.fr",{"name":39,"role":34,"phone":40,"phoneExt":36,"email":41},"Christophe MILESI, MD","04 67 336158","c-milesi@chu-montpellier.fr",[43],{"facility":44,"status":45,"city":46,"state":25,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"CHU de MONTPELLIER","RECRUITING","Montpellier","34090","France","FR",{"type":51,"coordinates":52},"Point",[53,54],3.87635,43.61093,{"lat":54,"lon":53},[57],{"name":25,"role":34,"phone":25,"phoneExt":25,"email":37},{"type":59,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100581277",false,"NCT06848218","Music Therapy During NIV Implantation in Pediatric Intensive Care Units","MusiNIV","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\u002F2014.\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\u002For child.","ALL","17 Years",{"count":69,"type":70},88,"ESTIMATED","INTERVENTIONAL",[73],"NA","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).",[76,77],"Acute Respiratory Failure (ARF)","Non Invasive Ventilation (NIV)",[22,79,80,81,82],"Non invasive Ventilation","Pediatric intensive care unit","Pain","Comfort","2025-06-30",{"date":85,"type":86},"2025-07-01","ACTUAL",{"date":88,"type":86},"2025-06-18",{"date":90,"type":70},"2027-04-01",{"name":5,"class":6},1]