NICU Music Therapy: Lessons Learned from a Randomized Trial

Mothers of infants hospitalized in the neonatal intensive care unit (NICU) are at risk for developing acute and posttraumatic stress disorder, but mothers' positive coping may improve with progress in the infant's well-being. There is a need to investigate complementary therapies that increase infant well-being and decrease maternal stress. A pacifier-activated lullaby (PAL) device is one evidence-based intervention to assist premature infants by playing a few bars of a lullaby after an effective suck, improving feeding behavior and shortening the length of NICU stay. The PAL may be personalized with lullabies sung and recorded by the neonate's mother or other family. This study's purpose was to quantify the effect of a PAL intervention on maternal stress symptoms. The experimental PAL intervention included a singing and recording session with a board-certified music therapist with NICU certification. This was a single-site randomized trial comparing the effect of maternal voice recording versus standard conditions. A total of 245 infant-mother dyads were screened; 18 mothers consented to participate and 12 were randomized to one of three conditions: mother's recorded lullaby for PAL administration, a generic female voice used for the PAL, and no intervention. Barriers arising during the study included lengthy enrollment processes, maternal visitation patterns, and an overly ambitious study design. Despite attempts to mitigate perceived barriers, we did not achieve the enrollment necessary to perform the intended analysis. We, therefore, present lessons learned and possible solutions for future music therapy research in the interest of transparency, reducing publication bias, and replication of problematic design issues in future trials.