Music Therapy for Pain Management for Minor Procedures in Neonates.
NCT ID: NCT04313179
Last Updated: 2021-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
100 participants
INTERVENTIONAL
2019-04-09
2020-02-25
Brief Summary
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Detailed Description
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One of the investigators involved in the study will obtain consent from the legal guardian and enroll the participants. All infants, regardless of the group that they are assigned, will receive similar standard non-pharmacologic method of pain relief which is 0.5 ml of 24% Sucrose, 2 minutes before undergoing heel prick. Pacifiers will be avoided to avoid potential confounding.
Subjects will be randomized into two different groups. Group A, music intervention group and group B, control group. In the music intervention group, a recorded instrumental lullaby music track called "Deep Sleep" from "Bedtime Mozart: Classical Lullabies for Babies", will be played for the neonates through smart phone speakers (maximum sound up to 60 A dB), starting 20 minutes before the heel prick, continuing through the procedure and for 5 minutes after the procedure. This music track has been selected based on previous research studies that showed effectiveness in neonatal pain management.
An investigator involved in the study will place the baby in a bassinet in a quite, dim lighted room. He/She will play the music for those babies in the music group and will NOT assess the NIPS. Another investigator wearing active noise cancelling Bluetooth headphones (for blinding) will enter the room at 5 minutes prior to the procedure and assess the NIPS at appropriate intervals: 5 minutes prior and at 1-minute interval during and after the procedure for 5 minutes. NIPS will be compared using appropriate statistical methods.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Music group
"Deep Sleep" music track from "Bedtime Mozart: Classical Lullabies for Babies", played through smart phone speakers, at maximum sound up to 45 dB, starting 20 minutes before the heel prick procedure, continuing through the procedure and for 5 minutes after the procedure. Also given 0.5 ml of 24% Sucrose given 2 minutes prior to heel prick procedure for baseline pain relief.
Music therapy
Mozart lullaby music
Sucrose
0.5 ml of 24% Sucrose
Placebo group
0.5 ml of 24% Sucrose given 2 minutes prior to heel prick procedure. No music played.
Sucrose
0.5 ml of 24% Sucrose
Interventions
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Music therapy
Mozart lullaby music
Sucrose
0.5 ml of 24% Sucrose
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Major congenital anomalies
* Failed hearing screen
37 Weeks
42 Weeks
ALL
Yes
Sponsors
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New York City Health and Hospitals Corporation
OTHER
Responsible Party
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Pratiba Ankola
MD, Neonatologist
Principal Investigators
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Prathiba Ankola, MD
Role: PRINCIPAL_INVESTIGATOR
Lincoln Medical Center
Locations
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Lincoln Medical Center
The Bronx, New York, United States
Countries
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References
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Standley J. Music therapy research in the NICU: an updated meta-analysis. Neonatal Netw. 2012 Sep-Oct;31(5):311-6. doi: 10.1891/0730-0832.31.5.311.
Bieleninik L, Ghetti C, Gold C. Music Therapy for Preterm Infants and Their Parents: A Meta-analysis. Pediatrics. 2016 Sep;138(3):e20160971. doi: 10.1542/peds.2016-0971. Epub 2016 Aug 25.
Shukla VV, Bansal S, Nimbalkar A, Chapla A, Phatak A, Patel D, Nimbalkar S. Pain Control Interventions in Preterm Neonates: A Randomized Controlled Trial. Indian Pediatr. 2018 Apr 15;55(4):292-296. Epub 2018 Feb 9.
Other Identifiers
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IRB#18-026
Identifier Type: -
Identifier Source: org_study_id
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