[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628556":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":10,"centralContacts":26,"locations":37,"responsibleParty":55,"collaborators":57,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":10,"maxAge":10,"enrollmentInfo":68,"targetDuration":10,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,13],{"label":9,"type":10,"description":10,"interventionNames":11},"Multidisciplinary expert committee",null,[12],"Other: Expert committee",{"label":14,"type":10,"description":10,"interventionNames":15},"Professionals",[16],"Other: Pre test",[18,22],{"type":6,"name":19,"description":20,"armGroupLabels":21,"otherNames":10},"Expert committee","A multidisciplinary expert committee will review all translated items of the COMFORTneo scale, including paramedical, medical, and translation professionals. Each item will be rated on a 4-point Likert scale to calculate the initial Content Validity Index (CVI).",[9],{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"Pre test","During the pretesting phase, items will be evaluated on a 5-point Likert scale by representative participants, and any item scored below 2\u002F5 by more than 20% of participants will be revised. The CVI will also be recalculated for each item and overall to confirm content validity.",[14],[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Louise CHARRIE","CONTACT","01 44 38 18 65","+33","louise.charrie@aphp.fr",{"name":34,"role":29,"phone":35,"phoneExt":31,"email":36},"Aline DECHANET","01 71 19 61 69","aline.dechanet@aphp.fr",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Centre d'Evaluation et de Traitement de la Douleur, Médecine Palliative (CETD-MP)","RECRUITING","Paris","Île-de-France Region","75015","France","FR",{"type":47,"coordinates":48},"Point",[49,50],2.3488,48.85341,{"lat":50,"lon":49},[53],{"name":28,"role":29,"phone":54,"phoneExt":31,"email":32},"01.44.38.18.65",{"type":56,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[58],{"name":59,"class":6},"URC-CIC Paris Descartes Necker Cochin","100628556","translation-and-cross-cultural-adaptation-into-french-of-the-comfortneo-pain-assessment-tool-for-newborns-100628556",false,"NCT07463170","Translation and Cross-Cultural Adaptation Into French of the COMFORTneo Pain Assessment Tool for Newborns","TradNeo","Inclusion Criteria:\n\n* Licensed healthcare professionals currently working in a neonatal care unit.\n* Healthcare professionals authorized by their professional qualifications or regulations to assess patient pain, including nurses, specialized nurses, and physicians.\n* Healthcare professionals employed at AP-HP (Assistance Publique - Hôpitaux de Paris).\n\nExclusion Criteria:\n\n\\- Refusal to participate, indicated by non-response to the questionnaire.","ALL",{"count":69,"type":70},50,"ESTIMATED","OBSERVATIONAL","Observational pain assessment scales are essential for the management of pain in young children, particularly in newborns.\n\nNumerous observational pain assessment scales for newborns and preterm infants exist worldwide; however, only four are available in validated French versions: EVENDOL, EDIN, DAN, and Comfort-B, each with specific indications for use. These scales were developed in France, validated in French, or recommended by expert groups (Comfort-B).\n\nThe COMFORTneo scale was developed and validated by a Dutch research team for the assessment of pain in term and preterm newborns, regardless of their level of ventilation or sedo-analgesia. Although it has been validated in several languages, no validated French translation is currently available.",[74],"Pain",[74,76,77,78,79],"Newborns","Pain Assessment Scales","COMFORTNeo","Cross-cultural Adaptation","2026-08-06",{"date":82,"type":83},"2026-08-10","ACTUAL",{"date":85,"type":83},"2026-06-02",{"date":87,"type":70},"2026-09",{"name":5,"class":6},1]