MUSIDORE PED Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain Management, Music Therapy

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Music Therapy during cleaning care 1<br>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.<br>* 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.<br>|
| Other: Music Therapy during cleaning care 2<br>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.<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric Critical ill care or intensive care, anxiety, pain