Effects of Oriental Music on Preterm Infants

American University of Beirut Medical Center

Status: Terminated

Conditions: Behavior, Child; Premature

Treatments: Other: Music exposure; Other: Silence

Study type: Interventional

Funder types: Other

Identifiers

NCT04565210

SBS-2020-0284

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 14 to 28 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

102 participants in 3 patient groups, including a placebo group

Oriental music

Experimental group

Description:

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

Treatment:

Other: Music exposure

Western music

Active Comparator group

Description:

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

Treatment:

Other: Music exposure

Silence / control

Placebo Comparator group

Description:

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

Treatment:

Other: Silence