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
| Type | Name | Description |
|---|---|---|
| DEVICE | Pain 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.