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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04565210
Other study ID # SBS-2020-0284
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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