Longitudinal Study of music Therapy’s Effectiveness for Premature infants and their caregivers (LongSTEP): protocol for an international randomised trial
Open accessAbstract
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, 2×2 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
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Interventions such as music therapy and kangaroo care can alleviate parental anxiety, promote mutual regulation within the parent-infant dyad, and enhance interaction quality.
“Studies have shown that interventions such as music therapy and kangaroo care can alleviate parental anxiety, promote mutual regulation within the parent‐infant dyad, and enhance interaction quality (Cristóbal et al. 2022; Ghetti et al. 2019).”
From Experiences and Perceptions of Hospital to Home Transitional Care for Parents of Premature Infants in Neonatal Intensive Care Unit: A Qualitative Meta‐Synthesis (2025) · cites this paper as Ghetti et al. 2019
The Background (page unavailable) reports that a meta-analysis found a favourable effect of music therapy on maternal anxiety and says skin-to-skin care can benefit bonding. Methods > Interventions (page unavailable) describes music therapy as promoting parent–infant mutual regulation and encouraging interaction. However, this trial protocol does not establish that kangaroo care alleviates parental anxiety or that either intervention improves interaction quality as a measured outcome. (LLM, conf=0.87)
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“The PBQ is a parent-rated screening instrument for disorders of the early mother-infant relationship consisting of 25 statements on a 6-point Likert scale (each 0–5; sum score ranging from 0 to 125; high=problematic), addressing problems in the mother–infant relationship based on weakened bonding; rejection and anger;…”
BackgroundMethodThe effects of music therapy on vital signs, feeding, and sleep in premature infants
Loewy, J., Stewart, K., Dassler, A.-M., Telsey, A., & Homel, P. (2013) · Pediatrics · doi:10.1542/peds.2012-1367 · Cited by 482 · see citing works
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Lu, Q., Liu, X., Shen, Q., Wang, S., & Liu, Z. (2025) · Nursing Open · doi:10.1002/nop2.70387 · Cited by 3 · see citing works
- Authors
- Ghetti, C., Bieleninik, Ł., Hysing, M., Kvestad, I., Assmus, J., Romeo, R., Ettenberger, M., Arnon, S., Vederhus, B. J., Söderström Gaden, T., & Gold, C.
- Affiliations
- NORCE Research AS (NO)
- University of Gdańsk (PL)
- King’s Health Economics, King’s College London, London, UK
- Fundación Santa Fe de Bogotá (CO)
- Tel Aviv University (IL)
- Haukeland University Hospital (NO)
- GAMUT - The Grieg Academy Music Therapy Research Centre, NORCE Norwegian Research Centre AS, Bergen, Norway
- Corresponding author
- Ghetti, Claire
- ORCID
- Venue
- BMJ Open
- Publisher
- BMJ
- Published
- 2019-08
- Volume
- 9
- Issue
- 8
- Pages
- e025062
- ISSN
- 2044-6055 (ISSN-L)
- PMC
- PMC6731830
- OpenAlex
- W2971820418
- Cited by
- 62
- References
- 7
- Citations by year
- 2026: 4 · 2025: 4 · 2024: 13 · 2023: 12 · 2022: 4 · 2021: 18 · 2020: 7
- FWCI
- 8.59
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by-nc
- Locations
- BMJ Open (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- NORA - Norwegian Open Research Archives (submittedVersion, cc-by-nc)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Research Portal (King's College London) (submittedVersion, other-oa)
- HighWire Press Open Archive (submittedVersion)
- Funders
- Norges Forskningsråd (273534)
- Universitetet i Bergen
- POLYFON Kunnskapsklynge for musikkterapi
- Topics
- Social Sciences › Psychology › Social Psychology › Music Therapy and Health
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Infant Development and Preterm Care
- Life Sciences › Neuroscience › Cognitive Neuroscience › Neuroscience and Music Perception
- Keywords
- music therapy, preterm infants, parent-infant bonding, neonatal intensive care, caregiver involvement, infant development, postpartum bonding, home-based intervention
- MeSH terms
- Child Development, Humans, Infant, Newborn, Infant, Premature, Infant, Premature, Diseases, Intensive Care Units, Neonatal, Mother-Child Relations, Music Therapy, Pilot Projects, Multicenter Studies as Topic, Intensive Care, Neonatal, Randomized Controlled Trials as Topic, Single-Blind Method, Caregivers, Pragmatic Clinical Trials as Topic
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