Effects of Oriental Music on Preterm Infants

Premature Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04565210
• Other study ID #: SBS-2020-0284
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: February 2022
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: December 30, 2023
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Behavior, Child
• Premature
• Premature Birth

Intervention

Other:
• Music exposure
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.
• Silence
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.

Locations

Country	Name	City	State
Lebanon	American University of Beirut	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability	It consists of changes in the time intervals between consecutive heartbeats called inter-beat intervals (RR).	3 years
Secondary	Mean Respiratory rate	The respiratory rate will be retrieved from bedside monitors.	3 years
Secondary	Oxygen Saturation	The oxygen saturation will be retrieved from bedside monitors.	3 years
Secondary	Behavioral state	The behavioral score will be assessed using a 7- point score by a certified nurse.	3 years