Longitudinal Study of music Therapy's Effectiveness for Premature infants and their caregivers (LongSTEP): protocol for an international randomised trial

被引：45

作者：

Ghetti, Claire ^{[1
,2
]}

Bieleninik, Lucja ^{[2
,3
]}

Hysing, Mari ^{[4
,5
]}

Kvestad, Ingrid ^{[5
]}

Assmus, Jorg ^{[2
]}

Romeo, Renee ^{[6
]}

Ettenberger, Mark ^{[7
,8
]}

Arnon, Shmuel ^{[9
,10
]}

Vederhus, Bente Johanne ^{[11
]}

Soderstrom Gaden, Tora ^{[2
]}

Gold, Christian ^{[2
]}

机构：

[1] Univ Bergen, Grieg Acad, GAMUT Grieg Acad Mus Therapy Res Ctr, Dept Mus, Bergen, Norway

[2] NORCE Norwegian Res Ctr AS, GAMUT Grieg Acad Mus Therapy Res Ctr, Bergen, Norway

[3] Uniwersytet Gdanski, Inst Psychol, Gdansk, Poland

[4] Univ Bergen, Dept Psychosocial Sci, Bergen, Norway

[5] NORCE Norwegian Res Ctr AS, Reg Ctr Child & Youth Mental Hlth & Child Welf, Bergen, Norway

[6] Kings Coll London, Kings Hlth Econ, London, England

[7] Hosp Univ Fdn Santa Fe Bogota, Dept Patient & Family Care, Bogota, Colombia

[8] SONO Ctr Musicoterapia, Bogota, Colombia

[9] Meir Med Ctr, Neonatal Dept, Kefar Sava, Israel

[10] Tel Aviv Univ, Sackler Sch Med, Tel Aviv, Israel

[11] Haukeland Hosp, Dept Pediat, Bergen, Norway

来源：

BMJ OPEN | 2019年 / 9卷 / 08期

关键词：

prematurity; caregiver; bonding; music therapy; non-pharmacological interventions; psychosocial interventions; randomised controlled trial; PRETERM BIRTH; SYSTEMATIC ANALYSIS; EARLY INTERVENTION; TIME TRENDS; STRESS; PARENTS; CHILDREN; FATHERS; NICU; ATTACHMENT;

D O I：

10.1136/bmjopen-2018-025062

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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 Design: international multicentre, assessor-blind, 2x2 factorial, pragmatic randomised controlled trial; informed by a completed feasibility study. Participants: 250 preterm infants and their parents. Intervention: MT focusing on parental singing specifically tailored to infant responses, will be delivered during NICU and/or during a postdischarge 6-month period. Primary outcome: changes in mother-infant bonding at 6-month corrected age (CA), as measured by the Postpartum Bonding Questionnaire. Secondary outcomes: 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

引用

页数：16

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