Short-term effectiveness of music therapy songwriting for mental health outcomes of at-risk parents in the NICU: a study protocol of an international multicenter mixed-methods trial.

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Preterm birth contributes to adverse mental health outcomes of parents dealing with a premature neonate. The main objective of this study is to determine whether music therapy (MT) songwriting during the infants' stay in the neonatal intensive care unit (NICU) is superior to standard care in reducing the risk of postpartum depression in high-risk parents of preterm children throughout the hospital treatment. The secondary objectives include assessment of effectiveness of MT in other aspects of mental health (anxiety level, perceived stress, mental wellbeing, coping, resilience). Furthermore, this trial will evaluate the medical and social factors that may be associated with the effects of MT songwriting. The study design is a sequential mixed method study with a dominant status QUAN to qual. The quantitative trial was designed as a parallel, multicenter, pragmatic, randomized controlled trial. The qualitative study is a descriptive phenomenological study that seeks to understand the lived experiences of participants exposed to songwriting. Participants are parents of premature infants hospitalized in NICU (106 families) in 5 hospitals, in Colombia and Poland. Intervention: 3 MT songwriting sessions per week across 3 weeks. Primary outcome: the risk of postnatal depression; secondary outcomes: anxiety level, mental wellbeing, resilience, stress, coping. The results will be analyzed quantitatively and qualitatively. This study will provide a report on the effectiveness of MT songwriting on mental health in at-risk parents of preterm infants.