Effects of Oriental Music oN Preterm InfAnts: A Randomized Controlled Trial. (OMNIA Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 102
- Locations
- 2
- Primary Endpoint
- Heart rate variability
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 14 Days to 28 Days (Child)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Heart rate variability
Time Frame: 3 years
It consists of changes in the time intervals between consecutive heartbeats called inter-beat intervals (RR).
Secondary Outcomes
- Mean Respiratory rate(3 years)
- Behavioral state(3 years)
- Oxygen Saturation(3 years)