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临床试验/NCT05578079
NCT05578079已完成不适用

The Effectiveness of Music on Pain During Heel Blood Collection in Premature Infants: A Double-Blind Randomized Controlled Trial

Izmir Katip Celebi University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年10月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Baby's heart rate

研究概览

简要总结

Premature babies receiving treatment and care in the Neonatal Intensive Care Unit (NICU) are exposed to various painful procedures. Repetitive and untreated painful procedures have a negative impact on the physiological, cognitive and behavioral development of the baby.

Various approaches such as white noise, music, lullaby, kangaroo care, breastfeeding, swaddling, massage, and therapeutic positioning are used to reduce the painful processes that newborns are exposed to in the NICU.

详细描述

Premature babies receiving treatment and care in the Neonatal Intensive Care Unit (NICU) are exposed to various painful procedures. Repetitive and untreated painful procedures have a negative impact on the physiological, cognitive and behavioral development of the baby.

Various approaches such as white noise, music, lullaby, kangaroo care, breastfeeding, swaddling, massage, and therapeutic positioning are used to reduce the painful processes that newborns are exposed to in the NICU.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Parent being voluntary to participate in the study
  • Being born at 32-36+6 gestastional week
  • The baby's condition is stable
  • Having passed hearing test
  • Having not congenital malformation

排除标准

  • Birth weight below 2500 g
  • Receiving analgesics or sedatives
  • Need for mechanical ventilation
  • Heel blood collection is not successful in the first time

结局指标

主要结局

Baby's heart rate

时间窗: 2 minutes after collecting heel blood

The baby's pulse rate will be measured.

Baby's respiratory rate

时间窗: 2 minutes after collecting heel blood

The baby's respiratory rate will be measured.

Premature Infant Pain Profile (PIPP)

时间窗: 2 minutes after collecting heel blood

PIPP scores will be evaluated separately by two experts in the field.

Baby's oxygen saturation

时间窗: 2 minutes after collecting heel blood

The baby's oxygen saturation will be measured.

次要结局

未报告次要终点

研究者

发起方
Izmir Katip Celebi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pınar Dogan

Research Ass.

Izmir Katip Celebi University

研究点 (1)

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