RecruitingNAINTERVENTIONAL

Music Therapy During NIV Implantation in Pediatric Intensive Care Units

This study aims to discover if listening to music can help children in intensive care feel less pain and discomfort when they start using a breathing aid called non-invasive ventilation (NIV). NIV helps children breathe without needing a tube inserted, which is better for them in many ways. However, starting NIV can sometimes be uncomfortable and even painful, leading to children not wanting to continue with it. Researchers want to compare children who listen to music during NIV setup with those who don't, to see if music therapy can make the experience easier. They'll measure pain levels carefully to find out if music is an effective way to improve comfort alongside standard medical care.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Montpellier

Enrolment target

Start

18 Jun 2025

Estimated completion

01 Apr 2027

Acute Respiratory Failure (ARF)Non Invasive Ventilation (NIV)

What is this study about?

When children are very ill and need help breathing, doctors sometimes use a machine called non-invasive ventilation (NIV). This machine helps push air into their lungs using a mask, without needing a tube put down their windpipe. This is usually much better for them and helps them recover faster.

However, putting on the NIV mask and adjusting it can sometimes feel uncomfortable or even painful for children. This discomfort can make it harder for them to get used to the machine, which then makes the treatment less effective. Doctors often use medicines to help with pain and anxiety, but these medicines can sometimes have side effects.

This study is looking into a different approach: using music therapy. Researchers want to see if listening to special music when NIV is first being set up can help children feel more relaxed and reduce their pain. The idea is to find out if music can be a helpful and gentle way to make this process more comfortable for children, potentially reducing the need for strong pain relief and its possible side effects.

Key takeaways

This study explores using music to reduce childhood pain during breathing support (NIV).
NIV helps children breathe without invasive tubes but can sometimes be uncomfortable.
The study aims to see if music therapy makes NIV setup more comfortable for children.
Children will be randomly assigned to either receive music or standard care.
Pain levels will be measured to compare the effectiveness of music.
Participation is voluntary and will not affect your child's medical treatment.

Who may be eligible?

This study is looking for children aged 17 and under who are currently in intensive care because they're struggling to breathe and their doctors think they need help from the NIV machine.

However, some children won't be able to join. For example, if a child has severe hearing loss, the music therapy wouldn't be very helpful. Also, if a child is so unwell they need the breathing machine straight away, there wouldn't be time to include them in the study. Children who are already using a breathing machine at home, or who are taking part in other specific types of medical research, also can't join.

Importantly, for any child to take part, their parents or legal guardians must give their full permission, and in some cases, the child themselves will need to agree too.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child aged 17 or under?
Is your child currently in a children's intensive care unit?
Does your child need help with breathing using a Non-Invasive Ventilation (NIV) machine?
Does your child have good hearing?
Are you both able to provide consent for your child to participate?

Answer every question to see your result.

What does participation involve?

If a child joins the study, they will be randomly placed into one of two groups. One group will listen to special music during the time the non-invasive ventilation (NIV) machine is being set up. The other group will receive the usual care without the music. Doctors and nurses will check the child's pain levels carefully before and during the NIV setup using a recognised score that looks at their facial expressions, body movements, and how they react. The study focuses on this single moment when NIV is initiated, so there aren't ongoing visits specifically for the study after that point. The aim is to see if music makes a difference during this initial setup.

Potential risks and benefits

The main benefit of taking part is that your child might feel more comfortable and experience less pain when starting non-invasive ventilation. There are no known physical risks associated with listening to music. The researchers will be carefully monitoring your child's comfort levels throughout. You are free to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

CHU de MONTPELLIER
Verified postcode
Montpellier, France· Recruiting

Common questions

What is Non-Invasive Ventilation (NIV)?

NIV is a breathing support treatment that uses a mask to help push air into your child's lungs without needing a tube in their windpipe. It helps them breathe more easily.

What is 'music therapy' in this study?

In this study, 'music therapy' means listening to specially designed music (from a program called 'Music Care') that aims to help children relax and feel less pain during the NIV setup.

Will my child definitely get music during the study?

Not necessarily. Children who join the study will be randomly put into two groups: one will get music therapy, and the other will get standard care without music. This helps compare the two methods fairly.

How will you know if the music helps?

Doctors and nurses will carefully check your child's pain levels before and during the NIV setup using a special scoring system. They won't know which group your child is in to keep things fair.

Can I still say no if my child meets the criteria?

Yes, taking part in any study is completely voluntary. You can always say no, or withdraw your child at any point, and it won't affect their medical care.

How to find out more

Sophie MOUNIER, MD

s-mounier@chu-montpellier.fr 04 67 33 66 09 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.