Personalized Music Therapy for Preterm Infants

NCT07295106 | Recruiting

• 3 other identifiers: MTR20245CLOCE-1558/24CET-4855/24
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Premature; Stress, Psychological

Keywords

Neonatal Intensive Care Unit; NICU; Music Therapy; Parental Voice; Tissue Oxygenation Index (TOI); Respiratory Rate; Near-Infrared Spectroscopy (NIRS); Heart Rate; Oxygen Saturation

Outcome Measures

Primary Outcomes (1)

• TOI 21 to 25 min

  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.

  Minutes 21-25 of each 50-minute Period (Phase 2)

Secondary Outcomes (12)

• 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)

Study Arms (2)

Sequence AB: PMT then Quiet Rest

EXPERIMENTAL

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.

Behavioral: Personalized Music Therapy (PMT); Behavioral: Quiet Rest

Sequence BA: Quiet Rest then PMT

EXPERIMENTAL

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.

Behavioral: Personalized Music Therapy (PMT); Behavioral: Quiet Rest

Interventions

Quiet Rest BEHAVIORAL

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.

Sequence AB: PMT then Quiet Rest; Sequence BA: Quiet Rest then PMT

Personalized Music Therapy (PMT) BEHAVIORAL

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.

Also known as: Music Therapy, Parental voice

Sequence AB: PMT then Quiet Rest; Sequence BA: Quiet Rest then PMT

Eligibility Criteria

• Age: 5 Days - 15 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fabrizio Faina: lead
• University Of Perugia: collaborator

Study Sites (1)

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

Perugia, PG, 06129, Italy

RECRUITING

Related Publications (5)

• Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.

  PMID: 8506163 BACKGROUND

• Yue W, Han X, Luo J, Zeng Z, Yang M. Effect of music therapy on preterm infants in neonatal intensive care unit: Systematic review and meta-analysis of randomized controlled trials. J Adv Nurs. 2021 Feb;77(2):635-652. doi: 10.1111/jan.14630. Epub 2020 Nov 17.

  PMID: 33200833 BACKGROUND

• Alderliesten T, Dix L, Baerts W, Caicedo A, van Huffel S, Naulaers G, Groenendaal F, van Bel F, Lemmers P. Reference values of regional cerebral oxygen saturation during the first 3 days of life in preterm neonates. Pediatr Res. 2016 Jan;79(1-1):55-64. doi: 10.1038/pr.2015.186. Epub 2015 Sep 21.

  PMID: 26389823 BACKGROUND

• van Bel F, Lemmers P, Naulaers G. Monitoring neonatal regional cerebral oxygen saturation in clinical practice: value and pitfalls. Neonatology. 2008;94(4):237-44. doi: 10.1159/000151642. Epub 2008 Sep 11.

  PMID: 18784420 BACKGROUND

• Meder U, Tarjanyi E, Kovacs K, Szakmar E, Cseko AJ, Hazay T, Belteki G, Szabo M, Jermendy A. Cerebral oxygenation in preterm infants during maternal singing combined with skin-to-skin care. Pediatr Res. 2021 Oct;90(4):809-814. doi: 10.1038/s41390-020-01235-2. Epub 2020 Dec 1.

  PMID: 33262445 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Stress, Psychological

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Fabrizio Faina

CONTACT

+39 075 585 8021; fabrizio.faina@unipg.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Registered Nurse (RN), Azienda Ospedaliera di Perugia; Program Coordinator, Degree Program in Nursing, University of Perugia; Sponsor-Investigator

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 19, 2025
• Study Start: October 13, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

IT (1)