Effects of Oriental Music on Preterm Infants

Not Applicable

Terminated

• Conditions: Premature; Behavior, Child
• Interventions: Other: Music exposure; Other: Silence

• Registration Number: NCT04565210
• Lead Sponsor: American University of Beirut Medical Center

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.

Detailed Description

Music exposure during care of preterm infants is the subject of increasing research. Many studies have shown positive impact of music exposure such as classical western music, lullabies or Quran on pain and physiological parameters of preterm infants in a neonatal intensive care unit (NICU) setting. No such study have explored the effect of oriental music which is the main popular music listened to in the Levant and Middle East and North Afrika (MENA) region.

We aim in this study to find out if the oriental music exposure in preterm infants improves babies' heart rate variability, physiological parameters and behavior state during their NICU stay.

Study Timeline

• Study First Submitted: 2020-09-07
• Study First Submitted QC: 2020-09-21
• Study First Posted: 2020-09-25
• Study Start: 2020-10-15
• Primary Completion: 2023-02-15
• Status Verified: 2024-10
• Study Completion: 2025-01-30
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oriental music	Music exposure	Infants assigned to this group will be exposed to oriental music.
Western music	Music exposure	Infants assigned to this group will be exposed to western music.
Silence / control	Silence	Infants assigned to this group will be exposed to the same protocol but using a track of silence.

Primary Outcome Measures

Name	Time	Method
Heart rate variability	3 years	It consists of changes in the time intervals between consecutive heartbeats called inter-beat intervals (RR).

Secondary Outcome Measures

Name	Time	Method
Mean Respiratory rate	3 years	The respiratory rate will be retrieved from bedside monitors.
Behavioral state	3 years	The behavioral score will be assessed using a 7- point score by a certified nurse.
Oxygen Saturation	3 years	The oxygen saturation will be retrieved from bedside monitors.

Trial Locations

Locations (1)

American University of Beirut; 🇱🇧 Beirut, Lebanon