Musical Intervention During IV-line Placement in Neonates

Not Applicable

Recruiting

• Conditions: Pain
• Interventions: Other: music

• Registration Number: NCT05926921
• Lead Sponsor: Spaarne Gasthuis

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.

Study Timeline

• Study First Submitted: 2023-06-09
• Study Start: 2023-06-19
• Study First Submitted QC: 2023-06-21
• Study First Posted: 2023-07-03
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-13
• Primary Completion: 2024-10-09
• Study Completion: 2024-10-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• has hearing impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
music	music	Brahms lullaby at 50-60dB (depending on distance to speaker), played during the intravenous line procedure.

Primary Outcome Measures

Name	Time	Method
NIPS	one day	neonatal infant pain scale
O2 Sat	one day	oxygen saturation
HR	one day	heart rate
RR / BR	one day	respiratory rate / breathing rate

Secondary Outcome Measures

Name	Time	Method
IV-line performers' experience (questionnaire)	one day	four short questions regarding staff' thoughts about the intervention
parents' experience (questionnaire)	one day	four short questions regarding parents' thoughts about the intervention

Trial Locations

Locations (1)

Spaarne Gasthuis Haarlem Zuid; 🇳🇱 Haarlem, Noord Holland, Netherlands