Musical Intervention During IV-line Placement in Neonates
ConditionPain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorSpaarne Gasthuis
About this trial
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:
1. Does playing a lullaby during intravenous line procedures affect the vital signs and behavior of a newborn, compared to not playing music? 2. 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
connected to a monitor that records vital signs
receives an IV-line
Disqualifiers
has hearing impairment
Trial design
Design model
Parallel
Treatments tested in this trial
music
Other interventionBrahms' Lullaby will be played from a speaker at 50 decibels
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: musicActive comparator 1 intervention
Group B: no musicNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
HR
heart rate
Time frame
one day2
RR / BR
respiratory rate / breathing rate
Time frame
one day3
O2 Sat
oxygen saturation
Time frame
one day4
NIPS
neonatal infant pain scale
Time frame
one daySecondary outcomes
1
parents' experience (questionnaire)
four short questions regarding parents' thoughts about the intervention
Time frame
one day2
IV-line performers' experience (questionnaire)
four short questions regarding staff' thoughts about the intervention
Time frame
one daySponsors and contacts
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Source ClinicalTrials.gov