Clinical Trials Directory

Trials / Completed

CompletedNCT03916835

MUSIDORE PED Study

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
University Hospital, Montpellier · Academic / Other
Sex
All
Age
6 Months – 15 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEPain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy.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.

Timeline

Start date
2019-05-28
Primary completion
2020-05-20
Completion
2020-05-20
First posted
2019-04-16
Last updated
2021-12-23

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03916835. Inclusion in this directory is not an endorsement.