MUSIDORE PED Study
- Conditions
- Pain ManagementMusic Therapy
- Interventions
- Device: Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy.
- Registration Number
- NCT03916835
- Lead Sponsor
- University Hospital, Montpellier
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- Deaf child
- Refusal of the child to participate in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Music Therapy during cleaning care 2 Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy. This group receives music therapy during cleaning care 2 and not during the cleaning care 1. Each patient will act as their own control Music Therapy during cleaning care 1 Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy. This group receives music therapy during cleaning care 1 and not during the cleaning care 2. Each patient will act as their own control
- Primary Outcome Measures
Name Time Method The FLACC (Face Legs Activity Cry Consolability) scale's score Day 2: During the care 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.
- Secondary Outcome Measures
Name Time Method Duration care Day 2 Time management during cleaning cares
Cardiac frequency Day 2 : During the care Values found on a device
breathing frequency Day 2: During the care Values found on a device
Mean arterial pressure Day 2: During the care Values found on a device
Trial Locations
- Locations (1)
Hopital Arnaud de Villeneuve- CHU Montpellier
🇫🇷Montpellier, France