Musical Intervention During IV-line Placement in Neonates

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05926921
• Other study ID #: newwave
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2023
• Est. completion date: October 9, 2024

Study information

• Verified date: June 2024
• Source: Spaarne Gasthuis
• Contact: Andrieke Knottnerus
• Phone: 0232240000
• Email: aknottnerus[@]spaarnegasthuis.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 9, 2024
• Est. primary completion date: October 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• connected to a monitor that records vital signs

• receives an IV-line

Exclusion Criteria:

• has hearing impairment

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• music
Brahms' Lullaby will be played from a speaker at 50 decibels

Locations

Country	Name	City	State
Netherlands	Spaarne Gasthuis Haarlem Zuid	Haarlem	Noord Holland

Sponsors (1)

Lead Sponsor	Collaborator
Spaarne Gasthuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HR	heart rate	one day
Primary	RR / BR	respiratory rate / breathing rate	one day
Primary	O2 Sat	oxygen saturation	one day
Primary	NIPS	neonatal infant pain scale	one day
Secondary	parents' experience (questionnaire)	four short questions regarding parents' thoughts about the intervention	one day
Secondary	IV-line performers' experience (questionnaire)	four short questions regarding staff' thoughts about the intervention	one day