MUSIDORE PED Study (MUSIDORE)

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.

Study Overview

• Status: Completed
• Conditions: Pain Management; Music Therapy
• Intervention / Treatment: Device: Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy.

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34090
    • Hopital Arnaud de Villeneuve- CHU Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 15 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Deaf child
• Refusal of the child to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Music Therapy during cleaning care 1; This group receives music therapy during cleaning care 1 and not during the cleaning care 2. Each patient will act as their own control	Device: 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.
Other: Music Therapy during cleaning care 2; This group receives music therapy during cleaning care 2 and not during the cleaning care 1. Each patient will act as their own control	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Day 2: During the care

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac frequency	Values found on a device	Day 1 : 10 minutes before the care
Cardiac frequency	Values found on a device	Day 1 : During the care
Cardiac frequency	Values found on a device	Day 2 : 10 minutes before the care
Cardiac frequency	Values found on a device	Day 2 : During the care
breathing frequency	Values found on a device	Day 1: 10 minutes before the care
breathing frequency	Values found on a device	Day 1: During the care
breathing frequency	Values found on a device	Day 2: 10 minutes before the care
breathing frequency	Values found on a device	Day 2: During the care
Mean arterial pressure	Values found on a device	Day 1: 10 minutes before the care
Mean arterial pressure	Values found on a device	Day 1: During the care
Mean arterial pressure	Values found on a device	Day 2: 10 minutes before the care
Mean arterial pressure	Values found on a device	Day 2: During the care
Duration care	Time management during cleaning cares	Day 1
Duration care	Time management during cleaning cares	Day 2

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2019
• Primary Completion (Actual): May 20, 2020
• Study Completion (Actual): May 20, 2020

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: pain; anxiety; Pediatric Critical ill care or intensive care
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anxiety Disorders; Agnosia; Therapeutics; Complementary Therapies; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Sensory Art Therapies; Music Therapy
• Other Study ID Numbers: UF 7654

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No