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Effects of Oriental Music on Preterm Infants

Effects of Oriental Music oN Preterm InfAnts: A Randomized Controlled Trial. (OMNIA Trial)

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04565210
Enrollment
102
Registered
2020-09-25
Start date
2020-10-15
Completion date
2025-01-30
Last updated
2025-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature, Behavior, Child

Keywords

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

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.

Interventions

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.

OTHERSilence

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.

Sponsors

American University of Beirut Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
14 Days to 28 Days
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Heart rate variability3 yearsIt consists of changes in the time intervals between consecutive heartbeats called inter-beat intervals (RR).

Secondary

MeasureTime frameDescription
Mean Respiratory rate3 yearsThe respiratory rate will be retrieved from bedside monitors.
Oxygen Saturation3 yearsThe oxygen saturation will be retrieved from bedside monitors.
Behavioral state3 yearsThe behavioral score will be assessed using a 7- point score by a certified nurse.

Countries

Lebanon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026