[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548599":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":30,"responsibleParty":101,"collaborators":105,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":18,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":18,"enrollmentInfo":116,"targetDuration":18,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":18,"overallStatus":33,"whyStopped":18,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Sanitas University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Music therapy songwriting + standard care","EXPERIMENTAL","The music therapy songwriting is a method frequently employed in music therapy sessions. This method involves the collaborative creation of lyrics and\u002For music with the participants. The intervention will consist of nine sessions, each of which will last approximately 30 to 45 minutes. Three sessions will be conducted per week until a minimum of six and a maximum of nine sessions are achieved.",[13],"Other: Music therapy songwriting",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard care","NO_INTERVENTION","Standard care is the usual care provided to parents of newborns hospitalized in a neonatal intensive care unit (NICU). This care includes providing information about the baby's health status and recommendations during contact with the baby. Additionally, when a health professional identifies symptoms of mental health disturbance in the parents, they are referred to a mental health professional for appropriate management.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Music therapy songwriting","Session 1: The goal of the first music therapy session is to know the parents musically and to provide information about song creation. This is achieved by exploring their favorite songs. Options for creating a song (original song or song parody) are presented and possibilities for creating lyrics are discussed.\n\nSessions 2-7: The structure of the song will be created and discussed with the parents. Parents will also be invited to include written messages from other family members in the lyrics if they wish. In each session, the developing welcome song is sung together with the parents, accompanied by the music therapist, who provides vocal or instrumental support.\n\nThe final sessions (Sessions 8-9) are dedicated to singing the final version of the song with the parents and their infant. Should the parents desire, a final recording of the song will also be made and the digital songbook will be created.",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Mark Ettenberger, PhD","CONTACT","+57 311 284 7635","mark.ettenberger@gmx.at",[31,47,54,71,83],{"facility":32,"status":33,"city":34,"state":35,"zip":18,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Clínica Iberoamérica en Colombia","RECRUITING","Barranquilla","Atlántico","Colombia","CO",{"type":39,"coordinates":40},"Point",[41,42],-74.78132,10.96854,{"lat":42,"lon":41},[45],{"name":26,"role":27,"phone":46,"phoneExt":18,"email":29},"+57 605 3319424",{"facility":48,"status":33,"city":49,"state":50,"zip":18,"country":36,"countryCode":37,"cosmosGeoPoint":18,"geoPoint":18,"contacts":51},"Clinica Pediátrica","Bogotá","Cundinamarca",[52],{"name":26,"role":27,"phone":53,"phoneExt":18,"email":29},"(+57) 601 745 5100",{"facility":55,"status":33,"city":49,"state":50,"zip":18,"country":36,"countryCode":37,"cosmosGeoPoint":18,"geoPoint":18,"contacts":56},"Clínica Universitaria Colombia",[57,60,63,65,67,69],{"name":58,"role":27,"phone":59,"phoneExt":18,"email":29},"Mark Ettenberger","(+57) 6015948650",{"name":61,"role":62,"phone":18,"phoneExt":18,"email":18},"Marcela Beltrán, MSc","SUB_INVESTIGATOR",{"name":26,"role":64,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"name":66,"role":62,"phone":18,"phoneExt":18,"email":18},"Angélica Hernández, MSc",{"name":68,"role":62,"phone":18,"phoneExt":18,"email":18},"Ana María Diaz, MSc",{"name":70,"role":62,"phone":18,"phoneExt":18,"email":18},"Johana Benavides, MSc",{"facility":72,"status":33,"city":73,"state":74,"zip":18,"country":36,"countryCode":37,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Clínica Keralty Ibagué","Ibague","Tolima Department",{"type":39,"coordinates":76},[77,78],-75.20289,4.43573,{"lat":78,"lon":77},[81],{"name":26,"role":27,"phone":82,"phoneExt":18,"email":29},"+57 60 1 646 6060",{"facility":84,"status":33,"city":85,"state":18,"zip":18,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"University of Gdańsk","Gdansk","Poland","PL",{"type":39,"coordinates":89},[90,91],18.64912,54.35227,{"lat":91,"lon":90},[94,98,99],{"name":95,"role":27,"phone":96,"phoneExt":18,"email":97},"Łucja Bieleninik, PhD","+48 58 523 30 00","lucja.bieleninik@ug.edu.pl",{"name":95,"role":64,"phone":18,"phoneExt":18,"email":18},{"name":100,"role":62,"phone":18,"phoneExt":18,"email":18},"Ilona Poćwierz-Marciniak, PhD",{"type":102,"investigatorFullName":103,"investigatorTitle":104,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Claudia Aristizábal","Director",[106],{"name":5,"class":6},"100548599","music-therapy-songwriting-and-mental-health-in-neonatel-intensive-care-unit-nicu-parents-100548599",false,"NCT06423092","Music Therapy Songwriting and Mental Health in Neonatel Intensive Care Unit (NICU) Parents","Short-term Effectiveness of Music Therapy Songwriting on Mental Health Outcomes of At-risk Parents in the Neonatal Intensive Care Unit: an International Multicenter Mixed-methods Study.","Inclusion Criteria:\n\n* The study population consisted of parents\u002Fcaregivers of newborns hospitalized in neonatal intensive care units (NICUs) with gestational ages of ≤32 weeks and expected hospitalizations of at least three weeks. In the case of a twin pregnancy, the firstborn infant was randomly assigned to one of the intervention groups, while both infants received the same treatment according to the outcome of randomization.\n* Mother a total score of ≥10 and\u002For father a total score of ≥7 on the EPDS (Edinburgh Postnatal Depression Scale)\n* Mother and\u002For father a total score of ≥8 on the GAD-7 (Generalized Anxiety Disorder Scale)\n\nExclusion Criteria:\n\n* Parents\u002Fcaregivers with known auditory problems that prevent participation in MT.\n\nMoreover parents\u002Fcaregivers with a documented mental illness or cognitive impairment that prevents them from being able to complete the study intervention or outcome assessments.\n\n* Parents\u002Fcaregivers of premature infants in palliative or end-of-life care, infants with known hearing impairment, or infants in the custody of social services.","ALL","18 Years",{"count":117,"type":118},102,"ESTIMATED","INTERVENTIONAL",[121],"NA","The mental health of parents of preterm newborns (PTNB) is negatively affected by prolonged hospitalization of the PTNB in the intensive care unit. This produces changes in the role of the parents and the bond with the newborn, leading to states of depression, anxiety, and stress. Several strategies, including music therapy, have been implemented to mitigate the negative impact on the parents' mental health.\n\nThe main objectives of the proposed trial are to determine whether Music Therapy (MT) songwriting combined with standard care (SC) during NICU stay is superior to SC alone in reducing the risk of postpartum depression in at-risk parents of preterm children at the end of treatment, and understand the lived experiences of participating parents who received music therapy for their mental health.",[124],"Mental Health Impairment","2024-09-06",{"date":127,"type":128},"2024-09-19","ACTUAL",{"date":130,"type":128},"2024-07-30",{"date":132,"type":118},"2026-06",{"name":103,"class":6},5]