Skip to main content
Clinical Trials/NCT03916835
NCT03916835
Completed
Not Applicable

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

University Hospital, Montpellier1 site in 1 country50 target enrollmentMay 28, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain Management
Sponsor
University Hospital, Montpellier
Enrollment
50
Locations
1
Primary Endpoint
The FLACC (Face Legs Activity Cry Consolability) scale's score
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 28, 2019
End Date
May 20, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

The FLACC (Face Legs Activity Cry Consolability) scale's score

Time Frame: 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 Outcomes

  • 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)

Study Sites (1)

Loading locations...

Similar Trials