¹University Medicine Essen, Department of Pediatrics I, Germany; University of Duisburg-Essen, Germany
²Alanus University of Arts and Social Sciences, Department of Arts Therapies and Therapy Sciences, Alfter, Germany
³University of Duisburg-Essen, Germany
⁴University Medicine Essen, Department of Pediatrics I, Germany

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Recent research found evidence supporting live performed music therapy for preterm infants to stabilize vital signs and promote neurodevelopment. There are currently some studies on the effectiveness of recorded music in premature infants. The effect of the same type of music with the same instrument, either live and individually performed according to the infants’ reactions or recorded, has not yet been investigated. The aim of this randomized-controlled trial was to investigate the effect of live performed music therapy (MT) and recorded music (RM), both with the instrument Sansula, compared to standard care (SC) on the preterm infants’ vital signs and behavior. The infants received either MT, RM or SC. Pre-, during- and post-therapy heart rates, respiratory rates, oxygen saturations and COMFORTneo scores were recorded for each session. 90 infants have been recruited from February 2024 to June 2025 and a total of 928 sessions was performed (MT=292, RM=329, SC=307). We observed lower COMFORTneo scores, heart and respiratory rates and higher oxygen saturation after live performed music therapy. Pre-therapy values were almost the same in all three groups for all variables, a higher mean response on COMFORTneo scale and vital signs was observed for MT (COMFORTneo score –5.1, heart rate –11.1 beats per min., respiratory rate –9.4 breaths per min, oxygen saturation +1.3%) compared to RM (COMFORTneo score –3.8, heart rate –4.4 beats per min., respiratory rate –2.9 breaths per min, oxygen saturation +0.6%). The vital sings and COMFORTneo score values before, during and after a session with SC remained approximately the same. Live performed music therapy benefits preterm infants’ vital signs and behavioral state and showed greater improvements than RM with the same sounds.