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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- TOI 21 to 25 min
Study Overview
Brief 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.
Detailed Description
Background and rationale. Preterm infants in the Neonatal Intensive Care Unit (NICU) are exposed to noise, light, and frequent handling, which can affect physiology and development and increase parental distress. Family-centered music therapy using the parental voice is a low-risk intervention that may modulate cerebral oxygenation and autonomic parameters during exposure. Neonatal NIRS studies report small-to-moderate average changes in cerebral oxygenation with parental voice or music and heterogeneous individual responses, supporting standardized procedures and within-participant designs (van Bel 2008; Alderliesten 2016; Meder 2021; Yue 2021).
Ethics and consent. Enrollment proceeds under Ethics Committee approval on file; written informed consent is obtained from the parent(s) or legal guardian(s) per local policy. Consent from both parents is sought when applicable; a single signature is acceptable in single-parent or court-sanctioned guardianship cases according to site policy.
Design. Single-center, randomized 2 by 2 crossover pilot. Infants are randomized to Sequence AB (Period 1 = PMT, washout 2 days, Period 2 = Quiet Rest) or Sequence BA (Period 1 = Quiet Rest, washout 2 days, Period 2 = PMT).
Pre-intervention voice preparation (outside study periods). A trained music therapist records the parent's singing or voice and performs basic audio processing (smoothing peaks, removing artifacts, setting a target intensity). The audio files are stored securely for audio playback during PMT. No outcomes are collected during preparation.
Conduct of each period (50 minutes, 8:00 to 9:00 PM local time, low-stimulation NICU room). A bedside speaker is positioned approximately 30 cm from the infant's head; audio playback is set to approximately 45 dBA (plus or minus 3) at the infant's ear level. Each period follows the same structure:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 5 Days to 15 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 ≥
- •Birth weight appropriate for gestational age, between the 50th and 90th percentile.
- •Written informed consent from parent(s) or legal guardian(s).
Exclusion Criteria
- •Post-operative status at the time of enrollment.
- •One or more of the following: intraventricular hemorrhage, necrotizing enterocolitis, sepsis, significant pulmonary disease, or neonatal anemia.
- •Congenital anomalies.
- •Hypersensitivity or intolerance to sound.
- •Maternal history of drug and/or alcohol misuse during pregnancy.
- •Lack of parental consent.
Outcomes
Primary Outcomes
TOI 21 to 25 min
Time Frame: Minutes 21-25 of each 50-minute Period (Phase 2)
Mean tissue oxygenation index (TOI, percent) over minutes 21 to 25. Primary comparison is the within-participant difference (PMT minus Quiet Rest) in a two-sequence, two-period crossover.
Secondary Outcomes
- TOI 5 to 9 min(Minutes 5-9 of each 50-minute Period (Phase 1))
- TOI 46 to 50 min(Minutes 46-50 of each 50-minute Period (Phase 3))
- HR 5 to 9 min(Minutes 5-9 of each 50-minute Period (Phase 1))
- HR 21 to 25 min(Minutes 21-25 of each 50-minute Period (Phase 2))
- HR 46 to 50 min(Minutes 46-50 of each 50-minute Period (Phase 3))
- RR 5 to 9 min(Minutes 5 to 9 of each 50-minute Period (Phase 1))
- RR 21 to 25 min(Minutes 21-25 of each 50-minute Period (Phase 2))
- RR 46 to 50 min(Minutes 46-50 of each 50-minute Period (Phase 3))
- SpO2 5 to 9 min(Minutes 5 to 9 of each 50-minute Period (Phase 1))
- SpO2 21 to 25 min(Minutes 21 to 25 of each 50-minute Period (Phase 2))
- SpO2 46 to 50 min(Minutes 46-50 of each 50-minute Period (Phase 3))
- PSS:NICU(Immediately after the intervention)
Investigators
Fabrizio Faina
Registered Nurse (RN), Azienda Ospedaliera di Perugia; Program Coordinator, Degree Program in Nursing, University of Perugia; Sponsor-Investigator
Azienda Ospedaliera di Perugia