Longitudinal Study of music Therapy's Effectiveness for Premature infants and their caregivers (LongSTEP): protocol for an international randomised trial.
Claire Ghetti, Łucja Bieleninik, Mari Hysing, Ingrid Kvestad, Jörg Assmus, Renee Romeo, Mark Ettenberger, Shmuel Arnon, Bente Johanne Vederhus, Tora Söderström Gaden, Christian Gold
Author Information
Claire Ghetti: GAMUT - The Grieg Academy Music Therapy Research Centre, The Grieg Academy - Department of Music, University of Bergen, Bergen, Norway Claire.Ghetti@uib.no.
Łucja Bieleninik: GAMUT - The Grieg Academy Music Therapy Research Centre, NORCE Norwegian Research Centre AS, Bergen, Norway.
Mari Hysing: Department of Psychosocial Science, University of Bergen, Bergen, Norway.
Ingrid Kvestad: Regional Center for Child and Youth Mental Health and Child Welfare, NORCE Norwegian Research Centre AS, Bergen, Norway.
Jörg Assmus: GAMUT - The Grieg Academy Music Therapy Research Centre, NORCE Norwegian Research Centre AS, Bergen, Norway.
Renee Romeo: King's Health Economics, King's College London, London, UK.
Mark Ettenberger: Department of Patient and Family Care, Hospital Universitario Fundacion Santa Fe de Bogotá, Bogotá, Colombia.
Shmuel Arnon: Neonatal Department, Meir Medical Center, Kfar Saba, Israel.
Bente Johanne Vederhus: Department of Pediatrics, Haukeland University Hospital, Bergen, Norway.
Tora Söderström Gaden: GAMUT - The Grieg Academy Music Therapy Research Centre, NORCE Norwegian Research Centre AS, Bergen, Norway.
Christian Gold: GAMUT - The Grieg Academy Music Therapy Research Centre, NORCE Norwegian Research Centre AS, Bergen, Norway. ORCID
INTRODUCTION: Preterm birth has major medical, psychological and socioeconomic consequences worldwide. Music therapy (MT) has positive effects on physiological measures of preterm infants and maternal anxiety, but rigorous studies including long-term follow-up are missing. Drawing on caregivers' inherent resources, this study emphasises caregiver involvement in MT to promote attuned, developmentally appropriate musical interactions that may be of mutual benefit to infant and parent. This study will determine whether MT, as delivered by a qualified music therapist during neonatal intensive care unit (NICU) hospitalisation and/or in home/municipal settings following discharge, is superior to standard care in improving bonding between primary caregivers and preterm infants, parent well-being and infant development. METHODS AND ANALYSIS: international multicentre, assessor-blind, 2×2 factorial, pragmatic randomised controlled trial; informed by a completed feasibility study. 250 preterm infants and their parents. MT focusing on parental singing specifically tailored to infant responses, will be delivered during NICU and/or during a postdischarge 6-month period. changes in mother-infant bonding at 6-month corrected age (CA), as measured by the Postpartum Bonding Questionnaire. : mother-infant bonding at discharge and at 12-month CA; child development over 24 months; and parental depression, anxiety and stress, and infant rehospitalisation, all over 12 months. ETHICS AND DISSEMINATION: The Regional Committees for Medical and Health Research Ethics approved the study (2018/994/REK Nord, 03 July 2018). Service users were involved in development of the study and will be involved in implementation and dissemination. Dissemination of findings will apply to local, national and international levels. TRIAL REGISTRATION NUMBER: NCT03564184.
