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Music Therapy for Pain Management for Minor Procedures in Neonates.

N

New York City Health and Hospitals Corporation

Status

Terminated

Conditions

Pain

Treatments

Other: Music therapy
Other: Sucrose

Study type

Interventional

Funder types

Other

Identifiers

NCT04313179
IRB#18-026

Details and patient eligibility

About

The aim of this study is to assess the effectiveness and safety of music therapy as adjuvant therapy for pain management in newborns undergoing minor painful procedures. It is a prospective study and we plan to enroll 200 healthy full term newborns undergoing minor procedures (heel pricks). They will be randomly assigned to either control or music group. Those in music group will receive recorded Mozart lullaby music. Pain will be assessed using NIPS (Neonatal Infant Pain Scale) scoring tool. The potential benefit of the study would be identifying music a safe and efficient adjuvant therapy for pain management in newborns.

Full description

This randomized, controlled, double blinded, clinical trial will include full term neonates undergoing painful minor procedures (heel pricks) in the Nursery unit of Lincoln Medical and Mental Health Center.

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.

Enrollment

100 patients

Sex

All

Ages

37 to 42 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • >37 weeks gestation babies

Exclusion criteria

  • <37 weeks gestation babies
  • Major congenital anomalies
  • Failed hearing screen

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups, including a placebo group

Music group
Experimental group
Description:
"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.
Treatment:
Other: Music therapy
Other: Sucrose
Placebo group
Placebo Comparator group
Description:
0.5 ml of 24% Sucrose given 2 minutes prior to heel prick procedure. No music played.
Treatment:
Other: Sucrose

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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