Musical Intervention During IV-line Placement in Neonates
'The Effect of Musical Intervention on the Indicators of Pain in Newborns Undergoing IV-line Placement'
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pain
Started Jun 2023
Typical duration for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2023
CompletedStudy Start
First participant enrolled
June 19, 2023
CompletedFirst Posted
Study publicly available on registry
July 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 9, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 9, 2024
CompletedJune 13, 2024
June 1, 2024
1.3 years
June 9, 2023
June 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
HR
heart rate
one day
RR / BR
respiratory rate / breathing rate
one day
O2 Sat
oxygen saturation
one day
NIPS
neonatal infant pain scale
one day
Secondary Outcomes (2)
parents' experience (questionnaire)
one day
IV-line performers' experience (questionnaire)
one day
Study Arms (2)
music
ACTIVE COMPARATORBrahms lullaby at 50-60dB (depending on distance to speaker), played during the intravenous line procedure.
no music
NO INTERVENTIONNo intervention, care as usual.
Interventions
Eligibility Criteria
You may qualify if:
- connected to a monitor that records vital signs
- receives an IV-line
You may not qualify if:
- has hearing impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Spaarne Gasthuislead
Study Sites (1)
Spaarne Gasthuis Haarlem Zuid
Haarlem, North Holland, 2035 RC, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2023
First Posted
July 3, 2023
Study Start
June 19, 2023
Primary Completion
October 9, 2024
Study Completion
October 9, 2024
Last Updated
June 13, 2024
Record last verified: 2024-06