Pain Management Via Music Therapy During Cleaning Cares in Pediatric Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The FLACC (Face Legs Activity Cry Consolability) scale's score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Deaf child
- •Refusal of the child to participate in the study
研究组 & 干预措施
Music Therapy during cleaning care 1
This group receives music therapy during cleaning care 1 and not during the cleaning care 2.
Each patient will act as their own control
干预措施: Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy. (Device)
Music Therapy during cleaning care 2
This group receives music therapy during cleaning care 2 and not during the cleaning care 1.
Each patient will act as their own control
干预措施: Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy. (Device)
结局指标
主要结局
The FLACC (Face Legs Activity Cry Consolability) scale's score
时间窗: 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.
次要结局
- Cardiac frequency(Day 2 : During the care)
- breathing frequency(Day 2: During the care)
- Duration care(Day 2)
- Mean arterial pressure(Day 2: During the care)