Effects of Oriental Music on Preterm Infants

NCT04565210 | Terminated

• 1 other identifier: SBS-2020-0284
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to explore the effect of oriental music on premature infants' physiological and behavioral parameters during their hospital stay in the NICU.

Conditions

Premature; Behavior, Child

Keywords

Music therapy; Premature infant; Heart rate variability; Behavior state

Outcome Measures

Primary Outcomes (1)

• Heart rate variability

  It consists of changes in the time intervals between consecutive heartbeats called inter-beat intervals (RR).

  3 years

Secondary Outcomes (3)

• Mean Respiratory rate

  3 years

• Oxygen Saturation

  3 years

• Behavioral state

  3 years

Study Arms (3)

Oriental music

EXPERIMENTAL

Infants assigned to this group will be exposed to oriental music.

Other: Music exposure

Western music

ACTIVE COMPARATOR

Infants assigned to this group will be exposed to western music.

Other: Music exposure

Silence / control

PLACEBO COMPARATOR

Infants assigned to this group will be exposed to the same protocol but using a track of silence.

Other: Silence

Interventions

Music exposure OTHER

Participants will be offered individual sessions of music. They will be exposed for 10 minutes per day, 3 days per week for a period of 2 weeks using a headphone.

Oriental music; Western music

Silence OTHER

Participants in this group will be offered individual silence session for 10 minutes per day, 3 days per week for a period of 2 weeks using a headphone.

Also known as: No music

Silence / control

Eligibility Criteria

• Age: 14 Days - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Clinically stable infants born between 28 and 366/7 weeks of gestation and ≥31 weeks Post Menstrual Age (PMA).
• Infants planned to stay in the NICU for at least 2 weeks at the time of enrollment.

You may not qualify if:

• Congenital anomaly affecting heart rate and hearing, significant brain insult (such as severe or moderate hypoxic ischemic encephalopathy, intraventricular hemorrhage (IVH) grade 3 or 4 or periventricular leukomalacia) that might affect the neurodevelopmental outcome.
• Receiving medications that might interfere with heart rate and reaction to music exposure such as midazolam or morphine.

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut

Beirut, 1107 2020, Lebanon

Location

MeSH Terms

Conditions

Premature Birth; Child Behavior

Interventions

SIR1 protein, S cerevisiae

Condition Hierarchy (Ancestors)

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

Study Officials

• Lama Charafeddine, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: September 25, 2020
• Study Start: October 15, 2020
• Primary Completion: February 15, 2023
• Study Completion: January 30, 2025
• Last Updated: April 4, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)