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Personalized Music Therapy for Preterm Infants

NCT07295106 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-19

No results posted yet for this study

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.

Conditions

  • Infant, Premature
  • Stress, Psychological

Interventions

BEHAVIORAL

Personalized Music Therapy (PMT)

Personalized Music Therapy (PMT): playback of the parent's recorded voice during Phase 2 (10 to 40 minutes) within a standardized 50 minute Period conducted in a low stimulation NICU room. Audio is prepared in advance by a trained music therapist (smoothing peaks, removing artifacts, setting a target level). Delivered via bedside speaker positioned approximately 30 cm from the infant's head; target intensity approximately 45 dBA (plus or minus 3 dB) at the infant's ear level. Phase 1 (0 to 9 minutes) and Phase 3 (40 to 50 minutes) are rest without added stimulation per protocol and are not part of the PMT exposure.

BEHAVIORAL

Quiet Rest

Quiet Rest: low stimulation rest during Phase 2 (10 to 40 minutes) within the same standardized 50 minute Period used for PMT. Phase 1 (0 to 9 minutes) and Phase 3 (40 to 50 minutes) are also rest without added stimulation. Room conditions and handling minimization match those used for PMT.

Sponsors & Collaborators

  • University Of Perugia

    collaborator OTHER

  • Fabrizio Faina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
5 Days
Max Age
15 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-13
Primary Completion
2026-01-31
Completion
2026-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07295106 on ClinicalTrials.gov