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MUSIDORE PED Study

Pain Management Via Music Therapy During Cleaning Cares in Pediatric Intensive Care Unit

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03916835
Acronym
MUSIDORE
Enrollment
50
Registered
2019-04-16
Start date
2019-05-28
Completion date
2020-05-20
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Music Therapy, Pain Management

Keywords

Pediatric Critical ill care or intensive care, anxiety, pain

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.

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.

Interventions

DEVICEPain 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.

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Months to 15 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The FLACC (Face Legs Activity Cry Consolability) scale's scoreDay 1 : 10 minutes before the careThe 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.

Secondary

MeasureTime frameDescription
Cardiac frequencyDay 1 : 10 minutes before the careValues found on a device
breathing frequencyDay 1: 10 minutes before the careValues found on a device
Mean arterial pressureDay 1: 10 minutes before the careValues found on a device
Duration careDay 1Time management during cleaning cares

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026