跳至主要内容
临床试验/NCT05926921
NCT05926921招募中不适用

'The Effect of Musical Intervention on the Indicators of Pain in Newborns Undergoing IV-line Placement'

Spaarne Gasthuis2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年6月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
NIPS

研究概览

简要总结

The goal of this clinical trial is to test the effect of music in reducing the pain felt by newborn children during an intravenous line procedure. An intravenous line is a small tube brought into a vein by using a needle. The main questions it aims to answer are:

  1. Does playing a lullaby during intravenous line procedures affect the vital signs and behavior of a newborn, compared to not playing music?
  2. How do parents and medical staff experience the music that's being played? Participants will all receive the same care and treatments as usual. The only difference being about half of the participants will be randomly assigned to the group that gets music.

Researchers will compare the music group to the non-music group to see if there is any difference in vital signs and behaviors of the child.

详细描述

After inclusion, a participant will be randomized by drawing a sealed, opaque envelope, the contents of which will be either group A: no music, or group B: music. The outcome assessor will then perform a baseline measurement of vital signs and Neonatal Infant Pain Score. Then, Brahms Lullaby will be played from a speaker. When the needle is first introduced into the skin, a second measurement will be performed. For every attempt needed to succesfully place the intravenous line, an additional measurement will be done. Finally, after succesful placement of the intravenous line is confirmed by NaCl flush, a final measurement will be done. Afterwards, a short questionnaire will be filled in by the parents and the medical staffmember(s) that performed the intravenous line.

The study groups will be compared to each other in outcome measures, and there will be statistical correction for demographic and clinical confounders, which will be collected from medical files. The research hypothesis is that group B will show a smaller increase in vital signs and NIPS on average during the procedure, compared to group A.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • connected to a monitor that records vital signs
  • receives an IV-line

排除标准

  • has hearing impairment

结局指标

主要结局

NIPS

时间窗: one day

neonatal infant pain scale

O2 Sat

时间窗: one day

oxygen saturation

HR

时间窗: one day

heart rate

RR / BR

时间窗: one day

respiratory rate / breathing rate

次要结局

  • IV-line performers' experience (questionnaire)(one day)
  • parents' experience (questionnaire)(one day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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