Pain ManagementMUSIDORENCT03916835
MUSIDORE PED Study
A study testing Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy. in people with Pain Management and Music Therapy, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The aim of this study is to measure the efficacy of music during a painful procedure in pediatric intensive care unit. Music therapy has real effects on the pain level already proven in adults units. Our objective is to apply this technic to children. Read more about this study
- Who is it for?
- Ages 6 months to 15 years
- Conditions the study is for
- Pain Management, Music Therapy
- What is being tested?
- Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 28 May 2019to 20 May 2020
- 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 6 months to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants between 6 months and 15 years old
- Vigil child
- Admitted to the department of Pediatric Critical Ill Unit at University Hospital in Montpellier (France)
- Signed both parental consent.
- Signed both parental authorization for videotape recording
- Parents or person with legal authority who speaks and understands french
Who cannot join
- Deaf child
- Refusal of the child to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Management Via Music Therapy During Cleaning Cares in Pediatric Intensive Care Unit
The aim of this study is to measure the efficacy of music during a painful procedure in pediatric intensive care unit.
Music therapy has real effects on the pain level already proven in adults units. Our objective is to apply this technic to children. The investigators will evaluate this technic during cleaning care which is daily procedure for each stable patient and wich may be painful in this population.
Read the detailed description
Pediatric intensive care units may be anxious places. A lot of painful and stressful procedures are done every day. A simple care such as a simple cleaning care may become painful or uncomfortable.
Usually those situation require the use of painkillers. For several years, new approaches are used in order to decrease the pain level without medication such as hypnosis or music therapy. Music therapy proved efficacy to reduce pain in different procedures and is currently used in adult intensive care units in order to decrease anxiety and pain.
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 our department and the investigators will study the effects on the pain level during a cleaning care .
The patients will be evaluated during two consecutive cleaning cares. One with and the other without music therapy. The investigators will compare the variation of the FLACC scores (before and during cleaning care ) to show a difference between both methods. The order (with or without) will be randomized. The patient will be his one control.
- Conditions
- Pain Management, Music Therapy
- Being tested
- Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy.
- Keywords
- Pediatric Critical ill care or intensive care, anxiety, pain
- Medical subject headings
- Agnosia, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy.Device
Each child will benefit two cleaning cares during hospitalization. One with music therapy and the other without music therapy.
Every time, the preparation will be the same with an equipment installation in order to keep comparability and blind.
Child will be videotaped without sound during the care. The order of music therapy intervention will be randomized.
| Study group | Role | What they receive |
|---|---|---|
| Music Therapy during cleaning care 1 | Other | This group receives music therapy during cleaning care 1 and not during the cleaning care 2.
Each patient will act as their own control Receives: Device: Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy. |
| Music Therapy during cleaning care 2 | Other | This group receives music therapy during cleaning care 2 and not during the cleaning care 1.
Each patient will act as their own control Receives: Device: Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The FLACC (Face Legs Activity Cry Consolability) scale's score
The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
Measured: Day 1 : 10 minutes before the care
The FLACC (Face Legs Activity Cry Consolability) scale's score
The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
Measured: Day 1: During the care
The FLACC (Face Legs Activity Cry Consolability) scale's score
The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
Measured: Day 2: 10 minutes before the care
The FLACC (Face Legs Activity Cry Consolability) scale's score
The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
Measured: Day 2: During the care
Secondary outcomes (14)
Cardiac frequency
Values found on a device
Measured: Day 1 : 10 minutes before the care
Cardiac frequency
Values found on a device
Measured: Day 1 : During the care
Cardiac frequency
Values found on a device
Measured: Day 2 : 10 minutes before the care
Cardiac frequency
Values found on a device
Measured: Day 2 : During the care
breathing frequency
Values found on a device
Measured: Day 1: 10 minutes before the care
breathing frequency
Values found on a device
Measured: Day 1: During the care
breathing frequency
Values found on a device
Measured: Day 2: 10 minutes before the care
breathing frequency
Values found on a device
Measured: Day 2: During the care
Mean arterial pressure
Values found on a device
Measured: Day 1: 10 minutes before the care
Mean arterial pressure
Values found on a device
Measured: Day 1: During the care
Mean arterial pressure
Values found on a device
Measured: Day 2: 10 minutes before the care
Mean arterial pressure
Values found on a device
Measured: Day 2: During the care
Duration care
Time management during cleaning cares
Measured: Day 1
Duration care
Time management during cleaning cares
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start28 May 2019
- Primary completion20 May 2020
- Study completion20 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916835
- Sponsor's protocol ID
- UF 7654
- Acronym
- MUSIDORE
- Status last verified
- May 2026
- First submitted
- 4 Apr 2019
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mounier S, Cambonie G, Baleine J, Le Roux M, Bringuier S, Milesi C. Music Therapy During Basic Daily Care in Critically Ill Children: A Randomized Crossover Clinical Trial. J Pediatr. 2024 Jan;264:113736. doi: 10.1016/j.jpeds.2023.113736. Epub 2023 Sep 16.
PubMed 37722559
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Management Via Music Therapy During Cleaning Cares in Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03916835
- Acronym / sponsor ID
- MUSIDORE / UF 7654
- Conditions
- Pain Management, Music Therapy
- Keywords
- Pediatric Critical ill care or intensive care, anxiety, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 28 May 2019 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 16 Apr 2019 (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 aim of this study is to measure the efficacy of music during a painful procedure in pediatric intensive care unit.
Music therapy has real effects on the pain level already proven in adults units. Our objective is to apply this technic to children. The investigators will evaluate this technic during cleaning care which is daily procedure for each stable patient and wich may be painful in this population.
Detailed description
Pediatric intensive care units may be anxious places. A lot of painful and stressful procedures are done every day. A simple care such as a simple cleaning care may become painful or uncomfortable.
Usually those situation require the use of painkillers. For several years, new approaches are used in order to decrease the pain level without medication such as hypnosis or music therapy. Music therapy proved efficacy to reduce pain in different procedures and is currently used in adult intensive care units in order to decrease anxiety and pain.
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 our department and the investigators will study the effects on the pain level during a cleaning care .
The patients will be evaluated during two consecutive cleaning cares. One with and the other without music therapy. The investigators will compare the variation of the FLACC scores (before and during cleaning care ) to show a difference between both methods. The order (with or without) will be randomized. The patient will be his one control.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Therapy during cleaning care 1 | Other | Device: Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy.This group receives music therapy during cleaning care 1 and not during the cleaning care 2. Each patient will act as their own control |
| Music Therapy during cleaning care 2 | Other | Device: Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy.This group receives music therapy during cleaning care 2 and not during the cleaning care 1. Each patient will act as their own control |
Who may qualify
- Ages
- 6 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Infants between 6 months and 15 years old
- Vigil child
- Admitted to the department of Pediatric Critical Ill Unit at University Hospital in Montpellier (France)
- Signed both parental consent.
- Signed both parental authorization for videotape recording
Key exclusion criteria (2 listed)
- Deaf child
- Refusal of the child to participate in the study
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 |
|---|---|---|
| Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy.Each child will benefit two cleaning cares during hospitalization. One with music therapy and the other without music therapy. Every time, the preparation will be the same with an equipment installation in order to keep comparability and blind. Child will be videotaped without sound during the care. The order of music therapy intervention will be randomized. | Device | Music Therapy during cleaning care 1, Music Therapy during cleaning care 2 |
Primary outcome
The FLACC (Face Legs Activity Cry Consolability) scale's score
Time frame: Day 1 : 10 minutes before the care
The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
The FLACC (Face Legs Activity Cry Consolability) scale's score
Time frame: Day 1: During the care
The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
The FLACC (Face Legs Activity Cry Consolability) scale's score
Time frame: Day 2: 10 minutes before the care
The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
The FLACC (Face Legs Activity Cry Consolability) scale's score
Time frame: Day 2: During the care
The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
14 secondary outcomes
Cardiac frequency
Time frame: Day 1 : 10 minutes before the care
Cardiac frequency
Time frame: Day 1 : During the care
Cardiac frequency
Time frame: Day 2 : 10 minutes before the care
Cardiac frequency
Time frame: Day 2 : During the care
breathing frequency
Time frame: Day 1: 10 minutes before the care
breathing frequency
Time frame: Day 1: During the care
breathing frequency
Time frame: Day 2: 10 minutes before the care
breathing frequency
Time frame: Day 2: During the care
Mean arterial pressure
Time frame: Day 1: 10 minutes before the care
Mean arterial pressure
Time frame: Day 1: During the care
Mean arterial pressure
Time frame: Day 2: 10 minutes before the care
Mean arterial pressure
Time frame: Day 2: During the care
Duration care
Time frame: Day 1
Duration care
Time frame: Day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Results publication: PubMed 37722559Mounier S, Cambonie G, Baleine J, Le Roux M, Bringuier S, Milesi C. Music Therapy During Basic Daily Care in Critically Ill Children: A Randomized Crossover Clinical Trial. J Pediatr. 2024 Jan;264:113736. doi: 10.1016/j.jpeds.2023.113736. Epub 2023 Sep 16.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy. in people with Pain Management and Music Therapy, 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 2 Jun 2026. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The FLACC (Face Legs Activity Cry Consolability) scale's score (time frame: Day 1 : 10 minutes before the care). 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?
On the ClinicalTrials.gov record for NCT03916835, which also lists 1 linked publication.
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 2 Jun 2026.