Musical Intervention During IV-line Placement in Neonates

Study Overview
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Brief Summary
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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: Does playing a lullaby during intravenous line procedures affect the vital signs and behavior of a newborn, compared to not playing music? 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.

Detailed Description
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Other: music


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: connected to a monitor that records vital signs receives an IV-line Exclusion Criteria: has hearing impairment
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: music<br>Brahms lullaby at 50-60dB (depending on distance to speaker), played during the intravenous line procedure. | Other: music<br>* Brahms' Lullaby will be played from a speaker at 50 decibels<br>|
| No Intervention: no music<br>No intervention, care as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HR | heart rate | one day | 
| RR / BR | respiratory rate / breathing rate | one day | 
| O2 Sat | oxygen saturation | one day | 
| NIPS | neonatal infant pain scale | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| parents' experience (questionnaire) | four short questions regarding parents' thoughts about the intervention | one day | 
| IV-line performers' experience (questionnaire) | four short questions regarding staff' thoughts about the intervention | one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intravenous line, newborn, music, pain management, musical therapy