PainNCT05926921
Musical Intervention During IV-line Placement in Neonates
A study testing music in people with Pain, run by Spaarne Gasthuis at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain
- What is being tested?
- music
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Jun 2023to 9 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- connected to a monitor that records vital signs
- receives an IV-line
Who cannot join
- has hearing impairment
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Spaarne Gasthuis Haarlem Zuid
Haarlem, North Holland, 2035 RC
About this study
Official title: 'The Effect of Musical Intervention on the Indicators of Pain in Newborns Undergoing IV-line Placement'
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:
- Does playing a lullaby during intravenous line procedures affect the vital signs and behavior of a newborn, compared to not playing music?
- 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.
Read the 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
- Being tested
- music
- Keywords
- intravenous line, newborn, music, pain management, musical therapy
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
musicOther
Brahms' Lullaby will be played from a speaker at 50 decibels
| Study group | Role | What they receive |
|---|---|---|
| music | Active comparator | Brahms lullaby at 50-60dB (depending on distance to speaker), played during the intravenous line procedure. Receives: Other: music |
| no music | No intervention | No intervention, care as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HR
heart rate
Measured: one day
RR / BR
respiratory rate / breathing rate
Measured: one day
O2 Sat
oxygen saturation
Measured: one day
NIPS
neonatal infant pain scale
Measured: one day
Secondary outcomes (2)
parents' experience (questionnaire)
four short questions regarding parents' thoughts about the intervention
Measured: one day
IV-line performers' experience (questionnaire)
four short questions regarding staff' thoughts about the intervention
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start19 Jun 2023
- Primary completion9 Oct 2024 (estimated)
- Study completion9 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spaarne Gasthuis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926921
- Sponsor's protocol ID
- newwave
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'The Effect of Musical Intervention on the Indicators of Pain in Newborns Undergoing IV-line Placement'
- ClinicalTrials.gov ID
- NCT05926921
- Acronym / sponsor ID
- newwave
- Conditions
- Pain
- Keywords
- intravenous line, newborn, music, pain management, musical therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Spaarne GasthuisUniversity, hospital or other
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 9 Oct 2024 (estimated)
- Study completion
- 9 Oct 2024 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does playing a lullaby during intravenous line procedures affect the vital signs and behavior of a newborn, compared to not playing music?
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| music | Active comparator | Other: musicBrahms lullaby at 50-60dB (depending on distance to speaker), played during the intravenous line procedure. |
| no music | No intervention | –No intervention, care as usual. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- connected to a monitor that records vital signs
- receives an IV-line
Key exclusion criteria (1 listed)
- has hearing impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| musicBrahms' Lullaby will be played from a speaker at 50 decibels | Other | music |
Primary outcome
HR
Time frame: one day
heart rate
RR / BR
Time frame: one day
respiratory rate / breathing rate
O2 Sat
Time frame: one day
oxygen saturation
NIPS
Time frame: one day
neonatal infant pain scale
2 secondary outcomes
parents' experience (questionnaire)
Time frame: one day
IV-line performers' experience (questionnaire)
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music in people with Pain, run by Spaarne Gasthuis at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrieke Knottnerus (0232240000, aknottnerus@spaarnegasthuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HR (time frame: one day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.