Effects of Oriental Music on Preterm Infants

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Premature, Behavior, Child

Intervention / Treatment
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* Other: Music exposure
* Other: Silence


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Days
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oriental music<br>Infants assigned to this group will be exposed to oriental music. | Other: Music exposure<br>* 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.<br>|
| Active Comparator: Western music<br>Infants assigned to this group will be exposed to western music. | Other: Music exposure<br>* 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.<br>|
| Placebo Comparator: Silence / control<br>Infants assigned to this group will be exposed to the same protocol but using a track of silence. | Other: Silence<br>* 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.<br>* Other names: No music;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability | It consists of changes in the time intervals between consecutive heartbeats called inter-beat intervals (RR). | 3 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Music therapy, Premature infant, Heart rate variability, Behavior state