跳至主要内容
临床试验/NCT04313179
NCT04313179终止不适用

Music Therapy as an Adjuvant Therapy for Pain Management During Heel Prick Procedures in Term Neonates.

New York City Health and Hospitals Corporation2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年4月9日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
100
试验地点
2
主要终点
Reduction in NIPS scoring by 20%

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
37 Weeks 至 42 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • >37 weeks gestation babies

排除标准

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

结局指标

主要结局

Reduction in NIPS scoring by 20%

时间窗: 5 minutes post procedure

A score greater than 3 indicates pain, maximum score is 7 and minimum is 0

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pratiba Ankola

MD, Neonatologist

New York City Health and Hospitals Corporation

研究点 (2)

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