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 (Voix Chantée)
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|ClinicalTrials.gov Identifier: NCT03830580|
Recruitment Status : Not yet recruiting
First Posted : February 5, 2019
Last Update Posted : February 5, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Prematurity Eye Fundus||Other: Positive stimulation (singing)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||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|
|Estimated Study Start Date :||February 2019|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2020|
|Experimental: Sung voice||
Other: Positive 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
|No Intervention: Control|
- Acute pain assessed by the PIPP (Premature Infant Pain Profile) scale [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830580
|Contact: Anne-Cécile CHARY-TARDYemail@example.com|
|CHU Dijon Bourgogne||Not yet recruiting|
|Dijon, France, 21000|
|Contact: Anne-Cécile CHARY-TARDY 03.80.29.33.62 firstname.lastname@example.org|