MUSIDORE PED Study

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Completed

CT.gov ID

NCT03916835

Collaborator

(none)

Enrollment

Location

Arms

11.8

Actual Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Management Music Therapy	Device: Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy.	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

May 28, 2019

Actual Primary Completion Date :

May 20, 2020

Actual Study Completion Date :

May 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: 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	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.
Other: 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	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.

Arm

Intervention/Treatment

Other: 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

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.

Other: 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

Device: Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy.

Outcome Measures

Primary Outcome Measures

The FLACC (Face Legs Activity Cry Consolability) scale's score [Day 1 : 10 minutes before 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.
The FLACC (Face Legs Activity Cry Consolability) scale's score [Day 1: 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.
The FLACC (Face Legs Activity Cry Consolability) scale's score [Day 2: 10 minutes before 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.
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

Cardiac frequency [Day 1 : 10 minutes before the care]
Values found on a device
Cardiac frequency [Day 1 : During the care]
Values found on a device
Cardiac frequency [Day 2 : 10 minutes before the care]
Values found on a device
Cardiac frequency [Day 2 : During the care]
Values found on a device
breathing frequency [Day 1: 10 minutes before the care]
Values found on a device
breathing frequency [Day 1: During the care]
Values found on a device
breathing frequency [Day 2: 10 minutes before the care]
Values found on a device
breathing frequency [Day 2: During the care]
Values found on a device
Mean arterial pressure [Day 1: 10 minutes before the care]
Values found on a device
Mean arterial pressure [Day 1: During the care]
Values found on a device
Mean arterial pressure [Day 2: 10 minutes before the care]
Values found on a device
Mean arterial pressure [Day 2: During the care]
Values found on a device
Duration care [Day 1]
Time management during cleaning cares
Duration care [Day 2]
Time management during cleaning cares

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Arnaud de Villeneuve- CHU Montpellier	Montpellier		France	34090

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Montpellier

ClinicalTrials.gov Identifier:

NCT03916835

Other Study ID Numbers:

UF 7654

First Posted:

Apr 16, 2019

Last Update Posted:

Dec 23, 2021

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Montpellier

Pediatric Critical ill care or intensive care

anxiety

pain

Study Results

No Results Posted as of Dec 23, 2021