MUSIDORE PED Study

University Hospital Center (CHU)

Status: Completed

Conditions: Pain Management; Music Therapy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03916835

UF 7654

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 6 months to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Music Therapy during cleaning care 1

Other group

Description:

This group receives music therapy during cleaning care 1 and not during the cleaning care 2. Each patient will act as their own control

Treatment:

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

Music Therapy during cleaning care 2

Other group

Description:

This group receives music therapy during cleaning care 2 and not during the cleaning care 1. Each patient will act as their own control

Treatment:

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