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Evaluation of the Effects of Personalized Music Therapy on Preterm Infants Admitted to the Neonatal Intensive Care Unit (NICU) and on Parental Stress: A Pilot Randomized Crossover Controlled Trial

Status: Recruiting

Location: See location...

Intervention Type: Behavioral

Study Type: Interventional

Study Phase: Not Applicable

SUMMARY

Preterm infants in the Neonatal Intensive Care Unit (NICU) face environmental and clinical stressors that may affect physiological stability and development. This pilot randomized crossover study tests Personalized Music Therapy (PMT) based on recorded parental voices versus Quiet Rest. Outcomes include tissue oxygenation index (TOI) via near-infrared spectroscopy (NIRS) and heart rate (HR), respiratory rate (RR), and oxygen saturation (SpO2). Each infant completes two Periods (PMT and Quiet Rest) in randomized order, separated by a 2-day washout. Parental stress is measured at discharge using the Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU). Findings inform feasibility, variance estimates, and protocol refinements for a larger trial.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 5 days

Maximum Age: 15 days

Healthy Volunteers: f

View:

• Preterm infants admitted to the Neonatal Intensive Care Unit (NICU) of Azienda Ospedaliera di Perugia, Santa Maria della Misericordia, Perugia (Italy) at the time of enrollment.

• Gestational age at birth 28+0 to 36+6 weeks.

• Age at enrollment: 5 to 15 days.

• Stable vital signs at enrollment per unit policy.

• Apgar score at 5 minutes ≥ 7.

• Birth weight appropriate for gestational age, between the 50th and 90th percentile.

• Written informed consent from parent(s) or legal guardian(s).

Locations

Other Locations

Italy

Neonatal Intensive Care Unit (NICU), Ospedale Santa Maria della Misericordia - Azienda Ospedaliera di Perugia

RECRUITING

Perugia

Contact Information

Primary

Fabrizio Faina

fabrizio.faina@unipg.it

+39 075 585 8021

Time Frame

Start Date: 2025-10-13

Estimated Completion Date: 2026-03

Participants

Target number of participants: 20

Treatments

Experimental: Sequence AB: PMT then Quiet Rest

Two period crossover. Period 1 = Personalized Music Therapy (PMT) during Phase 2 (10 to 40 min); Period 2 = Quiet Rest during Phase 2 (10 to 40 min). Washout between periods = 2 days. Each Period lasts 50 minutes (0 to 9 min Acclimation Rest; 10 to 40 min Treatment Exposure; 40 to 50 min Post-Exposure Rest). Measurements summarized as 5 minute window means at 5 to 9, 21 to 25, and 46 to 50 minutes.

Experimental: Sequence BA: Quiet Rest then PMT

Two period crossover. Period 1 = Quiet Rest during Phase 2 (10 to 40 min); Period 2 = Personalized Music Therapy (PMT) during Phase 2 (10 to 40 min). Washout between periods = 2 days. Each Period lasts 50 minutes (0 to 9 min Acclimation Rest; 10 to 40 min Treatment Exposure; 40 to 50 min Post-Exposure Rest). Measurements summarized as 5 minute window means at 5 to 9, 21 to 25, and 46 to 50 minutes.

Related Therapeutic Areas

Premature Infant

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