Clinical Trials Directory

Trials / Completed

CompletedNCT03830580

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
Centre Hospitalier Universitaire Dijon · Academic / Other
Sex
All
Age
1 Month – 4 Months
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
OTHERPositive stimulation (singing)A nurse or assistant trained in singing with an operal singer sings a lullaby She sits next to the incubator and sings from the time the sucrose is administered (2 minutes before the fundus exams is performed) until the end of the examination - taking into account the child's reaction

Timeline

Start date
2019-02-06
Primary completion
2019-08-08
Completion
2019-08-08
First posted
2019-02-05
Last updated
2024-02-23

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03830580. Inclusion in this directory is not an endorsement.