Clinical trial NCT05926921: Musical Intervention During IV-line Placement in Neonates
Official title: 'The Effect of Musical Intervention on the Indicators of Pain in Newborns Undergoing IV-line Placement'
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Keywords: intravenous line
newborn
music
pain management
musical therapy
Lead sponsor: Spaarne Gasthuis
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* connected to a monitor that records vital signs
* receives an IV-line

Exclusion Criteria:

* has hearing impairment

Primary outcomes:
measure: HR
timeFrame: one day
measure: RR / BR
timeFrame: one day
measure: O2 Sat
timeFrame: one day
measure: NIPS
timeFrame: one day
Secondary outcomes:
measure: parents' experience (questionnaire)
timeFrame: one day
measure: IV-line performers' experience (questionnaire)
timeFrame: one day
Other outcomes:
Locations:
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis Haarlem Zuid
state: Noord Holland
Study officials:
References: