Clinical trial NCT03916835: MUSIDORE PED Study
Official title: Pain Management Via Music Therapy During Cleaning Cares in Pediatric Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Music Therapy
Keywords: Pediatric Critical ill care or intensive care
anxiety
pain
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: The FLACC (Face Legs Activity Cry Consolability) scale's score
timeFrame: Day 1 : 10 minutes before the care
measure: The FLACC (Face Legs Activity Cry Consolability) scale's score
timeFrame: Day 1: During the care
measure: The FLACC (Face Legs Activity Cry Consolability) scale's score
timeFrame: Day 2: 10 minutes before the care
measure: The FLACC (Face Legs Activity Cry Consolability) scale's score
timeFrame: Day 2: During the care
Secondary outcomes:
measure: Cardiac frequency
timeFrame: Day 1 : 10 minutes before the care
measure: Cardiac frequency
timeFrame: Day 1 : During the care
measure: Cardiac frequency
timeFrame: Day 2 : 10 minutes before the care
measure: Cardiac frequency
timeFrame: Day 2 : During the care
measure: breathing frequency
timeFrame: Day 1: 10 minutes before the care
measure: breathing frequency
timeFrame: Day 1: During the care
measure: breathing frequency
timeFrame: Day 2: 10 minutes before the care
measure: breathing frequency
timeFrame: Day 2: During the care
measure: Mean arterial pressure
timeFrame: Day 1: 10 minutes before the care
measure: Mean arterial pressure
timeFrame: Day 1: During the care
measure: Mean arterial pressure
timeFrame: Day 2: 10 minutes before the care
measure: Mean arterial pressure
timeFrame: Day 2: During the care
measure: Duration care
timeFrame: Day 1
measure: Duration care
timeFrame: Day 2
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Hopital Arnaud de Villeneuve- CHU Montpellier
Study officials:
References: