Musical Intervention During IV-line Placement in Neonates

NCT ID: NCT05926921

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-19
• Study Completion Date: 2024-10-09

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

music

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

Group Type: ACTIVE_COMPARATOR

music

Intervention Type: OTHER

Brahms' Lullaby will be played from a speaker at 50 decibels

no music

No intervention, care as usual.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

music

Brahms' Lullaby will be played from a speaker at 50 decibels

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• has hearing impairment

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spaarne Gasthuis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Spaarne Gasthuis Haarlem Zuid

Haarlem, North Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Andrieke Knottnerus

Role: CONTACT

aknottnerus@spaarnegasthuis.nl

0232240000

Other Identifiers

newwave

Identifier Type: -

Identifier Source: org_study_id