Acute Respiratory Failure (ARF)MusiNIVNCT06848218
Music Therapy During NIV Implantation in Pediatric Intensive Care Units
A study testing Music Therapy and Setting Up NIV in people with Acute Respiratory Failure (ARF) and Non Invasive Ventilation (NIV), run by University Hospital, Montpellier at 1 site in France.
Trial summary
Non-invasive ventilation makes it possible to avoid intubation and improve patients' quality of life. However, pain is associated with discomfort and could lead to failure of this technique. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Acute Respiratory Failure (ARF), Non Invasive Ventilation (NIV)
- What is being tested?
- Music Therapy and Setting Up NIV
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jun 2025to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 0 to 17 inclusive
- Children hospitalized in pediatric intensive care unit
- Indication for NIV
Who cannot join
- - Severe deafness
- Clinical condition requiring immediate initiation of NIV
- Refusal to allow the child to be photographed
- Child not assessable by FLACC score (paralysis of lower limbs, etc.)
- Child already receiving NIV respiratory support at home
- Participation in other ongoing research involving the human person at major risk and constraint (RIPH category 1) or a drug trial according to European regulation 536/2014.
Show all 9Show fewer
- Absence of affiliation to a French social security scheme or beneficiary of such a scheme.
- Subject deprived of liberty (art.L. 1121-6 du CSP)
- Failure to obtain free and informed written or oral consent and authorization to take photographs from both parents (or from a single parent if the patient is accompanied by only one parent, in accordance with article 1122-2 of the French Public Health Code) or from the legal guardian and/or child.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de MONTPELLIER
Montpellier, 34090
s-mounier@chu-montpellier.fr
About this study
Non-invasive ventilation makes it possible to avoid intubation and improve patients' quality of life. However, pain is associated with discomfort and could lead to failure of this technique.
The aim of this study is to measure the effectiveness of music therapy on pain levels during non-invasive ventilation in critically ill children.
To this end, a pain score (Face Legs Activity Cry Consolability FLACC) will be assessed by raters blinded to the randomization arm during NIV initiation.
The FLACC score will be compared before and during implementation of NIV between two groups: a control group (without music therapy) and an experimental group (with music therapy).
Read the detailed description
Patient admitted to a Pediatric Intensive Care Unit are exposed to moderate to severe pain due to disease severity and invasive treatment or procedures.
Non invasive ventilation is an essential support in the treatment of infants and children with acute respiratory failure. Acceptance and tolerance are the keys to its success.
Comfort management, including pain management, is most often achieved through the administration of analgesic and/or sedative drugs (analgesics, anti-inflammatories, anxiolytics, hypnotics). However, these therapies, although effective, are not without risks, including potentially serious adverse effects (excessive sedation, prolonged hospitalization and ventilation, tolerance phenomena, withdrawal syndrome, delirium, constipation, etc.). These undesirable effects and their deleterious consequences prompt a more comprehensive approach to patient management, optimizing therapeutic strategies with the common aim of improving patient comfort and pain relief. One specific program, "Music Care" is based on a "U sequence" which use tempo and rhythm variations following the U scheme, to relax patients.
This program will be evaluated in the pediatric intensive care department and the investigators will study the effects on the pain level during a non invasive ventilation setting for children with respiratory failure.
the investigators will compare the variation of the FLACC scores (before and during nopn invasive ventilation setting) to show a difference between both methods. The order (with or without) will be randomized.
- Being tested
- Music Therapy, Setting Up NIV
- Keywords
- Music Therapy, Non invasive Ventilation, Pediatric intensive care unit, Pain, Comfort
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyOther
This procedure is carried out using headphones installed in the child's ears. The music will be activated if the child is in the Music group, and will not be activated but present if the child is not in the Music group.
NIV implementation will begin after 10 min of listening. The listening period will continue until the nadir period (when the music is slowest, for maximum relaxation), until 10 min after the start of the NIV.
Setting Up NIVProcedure or surgery
Non invasive ventilation is set up in several stages, with the help of at least two caregivers. The patient will be placed in a half-seated position or seated. Installation begins with the placement of the non invasive ventilation mask harness around the child's head, followed by the application of the mask to the face, held by a caregiver. Once the mask has been applied, ventilation is started by connecting the non invasive ventilation circuit to the mask. The harness is then tightened by the second caregiver.
| Study group | Role | What they receive |
|---|---|---|
| Non invasive ventilation setting with Music Therapy | Experimental | Each child will benefit non invasive ventilation setting for acute respiratory distress.
In this group, it will be with Music Therapy. Every time, the preparation will be the same with equipment installation with headphones for music listening, in order to keep comparability and blind for the evaluation. Sound will be activated in this group.
Each child will be videotaped during the non invasive ventilation setting. Receives: Other: Music Therapy; Procedure: Setting Up NIV |
| Non invasive ventilation setting without Music Therapy | Sham comparator | Each child will benefit Non invasive ventilation setting for acute respiratory distress.
In this group, it will be without Music therapy. Every time, the preparation will be the same with equipment installation with headphones for music listening, in order to keep comparability and blind for the evaluation. Sound will not be activated in this group.
Each child will be videotaped during the non invasive ventilation setting. Receives: Procedure: Setting Up NIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain variation before and during non invasive ventilation setting with and without music therapy.
FLACC (Face Legs Activity Cry Consolability) : The main assessment tool is a simple, rapid behavioral pain assessment scale, commonly used in the pediatric intensive care unit.
For each item, 3 possible scores: 0 or 1 or 2; the total score is from 0 (no pain) to 10 (severe pain).
The primary outcome is variation of the Face Legs Activity Cry Consolability (FLACC) score (range, 0-10) comparing before and during non invasive ventilation setting.
The first FLACC score evaluation will be just before the beginning of music. The Second FLACC score evaluation will be during the non invasive ventilation setting.
FLACC score evaluation over a 10-minute period, with selection of the highest score for each item during the evaluation period FLACC scores' evaluation will be done from videotape records without by 2 investigators The FLACC score will be determined blindly by two assessors who did not participate in the care, using the video taken when the NIV was set up.
Measured: assessment for 10 minutes before NIV start-up and for 10 minutes during NIV installation
Secondary outcomes (14)
Pain variation during and after non invasive ventilation setting with and without music therapy. the highest score for each parameter will be selected for each evaluation period of 10 minutes
FLACC (Face Legs Activity Cry Consolability) : The main assessment tool is a simple, rapid behavioral pain assessment scale, commonly used in the pediatric intensive care unit.
For each item, 3 possible scores: 0 or 1 or 2; the total score is from 0 (no pain) to 10 (severe pain).
The primary outcome is variation of the Face Legs Activity Cry Consolability (FLACC) score (range, 0-10) comparing before and during non invasive ventilation setting.
The first FLACC score evaluation will be just before the beginning of music. The Second FLACC score evaluation will be during the non invasive ventilation setting.
FLACC scores' evaluation will be done from videotape records without by 2 investigators
The FLACC score will be determined blindly by two assessors who did not participate in the care, using the video taken when the NIV was set up.
Measured: assessment for 10 minutes during NIV installation and for 10 minutes after NIV start-up
Physiological data variations between the 2 groups: HR
An initial reading will be taken 10 minutes before NIV start-up, during start-up and 10 minutes afterwards.
HR: heart rate in beats per minute the highest score for each parameter will be selected for each evaluation period of 10 minutes
Measured: assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up
Physiological data variations between the 2 groups: FR
An initial reading will be taken 10 minutes before NIV start-up, during start-up and 10 minutes afterwards.
FR: respiratory rate in inhalations per minute the highest score for each parameter will be selected for each evaluation period of 10 minutes
Measured: assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up
Physiological data variations between the 2 groups: SBP
An initial reading will be taken 10 minutes before NIV start-up, during start-up and 10 minutes afterwards.
SBP: systolic blood pressure in millimeters of mercury mmHg the highest score for each parameter will be selected for each evaluation period of 10 minutes
Measured: assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up
Physiological data variations between the 2 groups: MAP
An initial reading will be taken 10 minutes before NIV start-up, during start-up and 10 minutes afterwards.
MAP: mean arterial pressure in millimetres of mercury mmHg the highest score for each parameter will be selected for each evaluation period of 10 minutes
Measured: assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up
Physiological data variations between the 2 groups: SpO2
An initial reading will be taken 10 minutes before NIV start-up, during start-up and 10 minutes afterwards.
SpO² : blood oxygen saturation in percent the highest score for each parameter will be selected for each evaluation period of 10 minutes
Measured: assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up
Physiological data variations between the 2 groups: FiO2.
An initial reading will be taken 10 minutes before NIV start-up, during start-up and 10 minutes afterwards.
FiO2: fraction of inspired oxygen in percent the highest score for each parameter will be selected for each evaluation period of 10 minutes
Measured: assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up
NIV set-up time between groups
time from initiation to completion of NIV installation in minutes
Measured: from initiation to completion of NIV installation
Total NIV duration between groups
in hours
Measured: From initiation of the first NIV to the date of death or discharge from hospital, or up to 1 month after initiation of the NIV at the most
Failure to implement NIV between groups
in raw numbers
Measured: From initiation of the first NIV to the date of death or discharge from hospital, or up to 1 month after initiation of the NIV at the most
Use of sedative or anxiolytic drugs during NIV implantation between groups
dose in μg/kg/h
Measured: from initiation to completion of NIV installation
Length of stay in intensive care between groups
in days
Measured: from the date of admission in intensive care until discharge, or up to 1 month after initiation of NIV
total length of hospital stay between groups
in days
Measured: from the date of admission to hospital until discharge, or up to 1 month after initiation of NIV
comparison of the number of NIV-related complications between the 2 groups
Number of Complications of NIV, e.g. pneumothorax, decreased cardiac output (hypotension), gastric and abdominal distension, inhalation, nose, face and scalp pressure points, non-compliance, eye irritation
Measured: from the date of admission to hospital until discharge, or up to 1 month after initiation of NIV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start18 Jun 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Failure (ARF)Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Model description
- Prospective, single-center, randomized controlled study, with blinded assessment of primary endpoint.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848218
- Sponsor's protocol ID
- RECHMPL23_0191
- Acronym
- MusiNIV
- Status last verified
- Jun 2025
- First submitted
- 23 Jan 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy During NIV Implantation in Pediatric Intensive Care Units
- ClinicalTrials.gov ID
- NCT06848218
- Acronym / sponsor ID
- MusiNIV / RECHMPL23_0191
- Keywords
- Music Therapy, Non invasive Ventilation, Pediatric intensive care unit, Pain, Comfort
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 26 Feb 2025 (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.
Non-invasive ventilation makes it possible to avoid intubation and improve patients' quality of life. However, pain is associated with discomfort and could lead to failure of this technique.
The aim of this study is to measure the effectiveness of music therapy on pain levels during non-invasive ventilation in critically ill children.
To this end, a pain score (Face Legs Activity Cry Consolability FLACC) will be assessed by raters blinded to the randomization arm during NIV initiation.
The FLACC score will be compared before and during implementation of NIV between two groups: a control group (without music therapy) and an experimental group (with music therapy).
Detailed description
Patient admitted to a Pediatric Intensive Care Unit are exposed to moderate to severe pain due to disease severity and invasive treatment or procedures.
Non invasive ventilation is an essential support in the treatment of infants and children with acute respiratory failure. Acceptance and tolerance are the keys to its success.
Comfort management, including pain management, is most often achieved through the administration of analgesic and/or sedative drugs (analgesics, anti-inflammatories, anxiolytics, hypnotics). However, these therapies, although effective, are not without risks, including potentially serious adverse effects (excessive sedation, prolonged hospitalization and ventilation, tolerance phenomena, withdrawal syndrome, delirium, constipation, etc.). These undesirable effects and their deleterious consequences prompt a more comprehensive approach to patient management, optimizing therapeutic strategies with the common aim of improving patient comfort and pain relief. One specific program, "Music Care" is based on a "U sequence" which use tempo and rhythm variations following the U scheme, to relax patients.
This program will be evaluated in the pediatric intensive care department and the investigators will study the effects on the pain level during a non invasive ventilation setting for children with respiratory failure.
the investigators will compare the variation of the FLACC scores (before and during nopn invasive ventilation setting) to show a difference between both methods. The order (with or without) will be randomized.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, single-center, randomized controlled study, with blinded assessment of primary endpoint.
| Arm | Type | Receives |
|---|---|---|
| Non invasive ventilation setting with Music Therapy | Experimental | Other: Music Therapy, Procedure: Setting Up NIVEach child will benefit non invasive ventilation setting for acute respiratory distress. In this group, it will be with Music Therapy. Every time, the preparation will be the same with equipment installation with headphones for music listening, in order to keep comparability and blind for the evaluation. Sound will be activated in this group. Each child will be videotaped during the non invasive ventilation setting. |
| Non invasive ventilation setting without Music Therapy | Sham comparator | Procedure: Setting Up NIVEach child will benefit Non invasive ventilation setting for acute respiratory distress. In this group, it will be without Music therapy. Every time, the preparation will be the same with equipment installation with headphones for music listening, in order to keep comparability and blind for the evaluation. Sound will not be activated in this group. Each child will be videotaped during the non invasive ventilation setting. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 0 to 17 inclusive
- Children hospitalized in pediatric intensive care unit
- Indication for NIV
Key exclusion criteria (9 listed)
- - Severe deafness
- Clinical condition requiring immediate initiation of NIV
- Refusal to allow the child to be photographed
- Child not assessable by FLACC score (paralysis of lower limbs, etc.)
- Child already receiving NIV respiratory support at home
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 |
|---|---|---|
| Music TherapyThis procedure is carried out using headphones installed in the child's ears. The music will be activated if the child is in the Music group, and will not be activated but present if the child is not in the Music group. NIV implementation will begin after 10 min of listening. The listening period will continue until the nadir period (when the music is slowest, for maximum relaxation), until 10 min after the start of the NIV. | Other | Non invasive ventilation setting with Music Therapy |
| Setting Up NIVNon invasive ventilation is set up in several stages, with the help of at least two caregivers. The patient will be placed in a half-seated position or seated. Installation begins with the placement of the non invasive ventilation mask harness around the child's head, followed by the application of the mask to the face, held by a caregiver. Once the mask has been applied, ventilation is started by connecting the non invasive ventilation circuit to the mask. The harness is then tightened by the second caregiver. | Procedure or surgery | Non invasive ventilation setting with Music Therapy, Non invasive ventilation setting without Music Therapy |
Primary outcome
Pain variation before and during non invasive ventilation setting with and without music therapy.
Time frame: assessment for 10 minutes before NIV start-up and for 10 minutes during NIV installation
FLACC (Face Legs Activity Cry Consolability) : The main assessment tool is a simple, rapid behavioral pain assessment scale, commonly used in the pediatric intensive care unit. For each item, 3 possible scores: 0 or 1 or 2; the total score is from 0 (no pain) to 10 (severe pain). The primary outcome is variation of the Face Legs Activity Cry Consolability (FLACC) score (range, 0-10) comparing before and during non invasive ventilation setting. The first FLACC score evaluation will be just before the beginning of music. The Second FLACC score evaluation will be during the non invasive ventilation setting. FLACC score evaluation over a 10-minute period, with selection of the highest score for each item during the evaluation period FLACC scores' evaluation will be done from videotape records without by 2 investigators The FLACC score will be determined blindly by two assessors who did not participate in the care, using the video taken when the NIV was set up.
14 secondary outcomes
Pain variation during and after non invasive ventilation setting with and without music therapy. the highest score for each parameter will be selected for each evaluation period of 10 minutes
Time frame: assessment for 10 minutes during NIV installation and for 10 minutes after NIV start-up
Physiological data variations between the 2 groups: HR
Time frame: assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up
Physiological data variations between the 2 groups: FR
Time frame: assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up
Physiological data variations between the 2 groups: SBP
Time frame: assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up
Physiological data variations between the 2 groups: MAP
Time frame: assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up
Physiological data variations between the 2 groups: SpO2
Time frame: assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up
Physiological data variations between the 2 groups: FiO2.
Time frame: assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up
NIV set-up time between groups
Time frame: from initiation to completion of NIV installation
Total NIV duration between groups
Time frame: From initiation of the first NIV to the date of death or discharge from hospital, or up to 1 month after initiation of the NIV at the most
Failure to implement NIV between groups
Time frame: From initiation of the first NIV to the date of death or discharge from hospital, or up to 1 month after initiation of the NIV at the most
Use of sedative or anxiolytic drugs during NIV implantation between groups
Time frame: from initiation to completion of NIV installation
Length of stay in intensive care between groups
Time frame: from the date of admission in intensive care until discharge, or up to 1 month after initiation of NIV
total length of hospital stay between groups
Time frame: from the date of admission to hospital until discharge, or up to 1 month after initiation of NIV
comparison of the number of NIV-related complications between the 2 groups
Time frame: from the date of admission to hospital until discharge, or up to 1 month after initiation of NIV
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 Therapy and Setting Up NIV in people with Acute Respiratory Failure (ARF) and Non Invasive Ventilation (NIV), run by University Hospital, Montpellier at 1 site in France.
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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 1 Jul 2025. 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 France. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie MOUNIER, MD (04 67 33 66 09 ext. +33, s-mounier@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain variation before and during non invasive ventilation setting with and without music therapy. (time frame: assessment for 10 minutes before NIV start-up and for 10 minutes during NIV installation). 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 1 Jul 2025.