MUSIDORE PED Study

NCT03916835 | Completed

• 1 other identifier: UF 7654
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pain Management; Music Therapy

Keywords

Pediatric Critical ill care or intensive care; anxiety; pain

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (14)

• Cardiac frequency

  Day 1 : 10 minutes before the care

• Cardiac frequency

  Day 1 : During the care

• Cardiac frequency

  Day 2 : 10 minutes before the care

• Cardiac frequency

  Day 2 : During the care

• breathing frequency

  Day 1: 10 minutes before the care

Study Arms (2)

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

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

Device: Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy.

Interventions

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.

Music Therapy during cleaning care 1; Music Therapy during cleaning care 2

Eligibility Criteria

• Age: 6 Months - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Hopital Arnaud de Villeneuve- CHU Montpellier

Montpellier, 34090, France

Location

Related Publications (1)

• 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.

  PMID: 37722559 RESULT

MeSH Terms

Conditions

Agnosia; Anxiety Disorders; Pain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 16, 2019
• Study Start: May 28, 2019
• Primary Completion: May 20, 2020
• Study Completion: May 20, 2020
• Last Updated: June 2, 2026

Record last verified: 2026-05

Locations

FR (1)