NCT04759170

The Effects of Recorded Receptive Music Therapy on Oral Nutrition and the Well-being of the Italian Premature Baby

Completed NA Last updated 20 April 2022

What this trial tests

NA trial testing Music therapy in Music Therapy in 40 participants. Completed in 27 December 2021.

Timeline

30 August 2020

Primary endpoint
10 February 2021

27 December 2021

Quick facts

Lead sponsor	Ospedale di Circolo - Fondazione Macchi
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	30 August 2020
Primary completion	10 February 2021
Estimated completion	27 December 2021
Sites	1 location across Italy

Drugs / interventions tested

• Music therapy

Conditions studied

• Music Therapy — all drugs for Music Therapy →

Sponsor

Ospedale di Circolo - Fondazione Macchi — full company profile →

Who can join

Adults 23 Weeks to 34 Weeks, any sex, with Music Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigators have thought with a dedicated research group, to deepen the use of receptive music therapy so that it can improve the non-nutritive sucking of premature babies through listening to lullabies sung by parents and by the music therapist, which can reduce the use feeding tube and the negative effects on stress or growth of the newborn. The acquisition of oral skills and the achievement of a complete autonomous suction are of fundamental importance for the discharge of the preterm infant. Some studies published in the literature suggest that listening to the mother's voice and lullabies can represent a positive auditory stimulus for babies to support nutritional and non-nutritive sucking (NNS). Positive reinforcement is an effective development strategy for improving the feeding skills of preterm infants. A brief receptive music therapy intervention with the infant's personal pacifier that plays lullabies sung by both parents or by the music therapist could reduce the use of the feeding tube and the length of hospitalization. The possible negative effects of this stimulation on infant stress or growth remain to be explored. The aim of this study is not only to evaluate the benefits of positive reinforcement on the nutritional sucking competence of the premature baby, but at the same time also to observe the possible effects on his well-being and on his clinical stability.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Musical and vocal interventions to improve neurodevelopmental outcomes for preterm infants.
   Haslbeck FB, Mueller K, Karen T, Loewy J, et al · · 2023 · cited 24× · PMID 37675934 · DOI 10.1002/14651858.cd013472.pub2