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临床试验/NCT03830580
NCT03830580已完成不适用

Benefit of Singing in the Care of Premature Children Undergoing Screening for Retinopathy of Prematurity in the Neonatology and Neonatal Resuscitation Unit of the Dijon University Hospital

Centre Hospitalier Universitaire Dijon2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年2月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Acute pain assessed by the PIPP (Premature Infant Pain Profile) scale

研究概览

简要总结

As part of the regular procedure for premature births, premature infants undergo several screening examinations, including an examination of the fundus. This examination seeks to establish whether the infant has retinopathy of prematurity. This disease affects the vessels of the retina of the eye, especially in prematurely born children, and can lead to serious complications such as blindness if it is not treated in time.

The purpose of this study is to assess the discomfort caused by the screening in order to improve practices. To do this, the investigators would like to evaluate whether soft auditory stimulation, more precisely a person singing, would improve the children's level of comfort during the examination.

To do this, the participating children will be divided into 2 groups:

  • The "Singing" group will receive the usual comfort treatments (placed in a 'nest', pacifier and sugar water) and a trained professional will sing a lullaby or nursery rhyme at the same time
  • control group will receive the usual comfort care (placed in a 'nest', pacifier and sugar water) The child's head and entire body will be filmed, which will allow an evaluator to assess the child's comfort.

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

年龄范围
1 Month 至 4 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infant born prematurely before the end of 31 weeks of amenorrhoea and/or with a birth weight of less than 1250g
  • Infant in whom a first screening examination (fundus) for retinopathy of prematurity (i.e. around 32 WA) must be carried out according to term by hospital protocol
  • Infant hospitalized in the neonatal paediatrics and intensive care unit of the Dijon University Hospital
  • Infant affiliated to the national medical insurance system
  • Oral agreement of one of the two parents

排除标准

  • Infants with contraindications to the use of Algopedol® 24% sugar solution, NEOSYNEPHRINE 2.5% mydriatic eye drops for pupillary dilatation, MYDRIATICUM 0.5% mydriatic eye drops for pupillary dilatation and OXYBUPROCAINE analgesic eye drops
  • Infant with known deafness and no hearing aid
  • Premature infant in critical condition
  • Infant with hemodynamic and clinical instability making it impossible to perform the fundus examination because of the risk of decompensation
  • Parent refuses the videotaping

研究组 & 干预措施

Sung voice

Experimental

干预措施: Positive stimulation (singing) (Other)

Control

No Intervention

结局指标

主要结局

Acute pain assessed by the PIPP (Premature Infant Pain Profile) scale

时间窗: During the examination

The children's faces and bodies will be filmed - without sound - during the examination. The nurse who examines the fundus will start and finish the video recording.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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