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Effects of Oriental Music on Preterm Infants

Primary Purpose

Premature, Behavior, Child

Status
Recruiting
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Music exposure
Silence
Sponsored by
American University of Beirut Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premature focused on measuring Music therapy, Premature infant, Heart rate variability, Behavior state

Eligibility Criteria

14 Days - 28 Days (Child)All SexesAccepts 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.

Sites / Locations

  • American University of BeirutRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Oriental music

Western music

Silence / control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Heart rate variability
It consists of changes in the time intervals between consecutive heartbeats called inter-beat intervals (RR).

Secondary Outcome Measures

Mean Respiratory rate
The respiratory rate will be retrieved from bedside monitors.
Oxygen Saturation
The oxygen saturation will be retrieved from bedside monitors.
Behavioral state
The behavioral score will be assessed using a 7- point score by a certified nurse.

Full Information

First Posted
September 7, 2020
Last Updated
February 17, 2022
Sponsor
American University of Beirut Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04565210
Brief Title
Effects of Oriental Music on Preterm Infants
Official Title
Effects of Oriental Music oN Preterm InfAnts: A Randomized Controlled Trial. (OMNIA Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
February 15, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American University of Beirut Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature, Behavior, Child
Keywords
Music therapy, Premature infant, Heart rate variability, Behavior state

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oriental music
Arm Type
Experimental
Arm Description
Infants assigned to this group will be exposed to oriental music.
Arm Title
Western music
Arm Type
Active Comparator
Arm Description
Infants assigned to this group will be exposed to western music.
Arm Title
Silence / control
Arm Type
Placebo Comparator
Arm Description
Infants assigned to this group will be exposed to the same protocol but using a track of silence.
Intervention Type
Other
Intervention Name(s)
Music exposure
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Silence
Other Intervention Name(s)
No music
Intervention Description
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.
Primary Outcome Measure Information:
Title
Heart rate variability
Description
It consists of changes in the time intervals between consecutive heartbeats called inter-beat intervals (RR).
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Mean Respiratory rate
Description
The respiratory rate will be retrieved from bedside monitors.
Time Frame
3 years
Title
Oxygen Saturation
Description
The oxygen saturation will be retrieved from bedside monitors.
Time Frame
3 years
Title
Behavioral state
Description
The behavioral score will be assessed using a 7- point score by a certified nurse.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Days
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lama Charafeddine, MD
Organizational Affiliation
American University of Beirut Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
American University of Beirut
City
Beirut
ZIP/Postal Code
1107 2020
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lama Charafeddine, M.D
Phone
009611350000
Ext
5874
Email
lc12@aub.edu.lb

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Oriental Music on Preterm Infants

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