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MUSIDORE PED Study (MUSIDORE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03916835
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.


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.





Primary Outcome Measures :
  1. The FLACC (Face Legs Activity Cry Consolability) scale's score [ Time Frame: 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.

  2. The FLACC (Face Legs Activity Cry Consolability) scale's score [ Time Frame: 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.

  3. The FLACC (Face Legs Activity Cry Consolability) scale's score [ Time Frame: 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.

  4. 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 Outcome Measures :
  1. Cardiac frequency [ Time Frame: Day 1 : 10 minutes before the care ]
    Values found on a device

  2. Cardiac frequency [ Time Frame: Day 1 : During the care ]
    Values found on a device

  3. Cardiac frequency [ Time Frame: Day 2 : 10 minutes before the care ]
    Values found on a device

  4. Cardiac frequency [ Time Frame: Day 2 : During the care ]
    Values found on a device

  5. breathing frequency [ Time Frame: Day 1: 10 minutes before the care ]
    Values found on a device

  6. breathing frequency [ Time Frame: Day 1: During the care ]
    Values found on a device

  7. breathing frequency [ Time Frame: Day 2: 10 minutes before the care ]
    Values found on a device

  8. breathing frequency [ Time Frame: Day 2: During the care ]
    Values found on a device

  9. Mean arterial pressure [ Time Frame: Day 1: 10 minutes before the care ]
    Values found on a device

  10. Mean arterial pressure [ Time Frame: Day 1: During the care ]
    Values found on a device

  11. Mean arterial pressure [ Time Frame: Day 2: 10 minutes before the care ]
    Values found on a device

  12. Mean arterial pressure [ Time Frame: Day 2: During the care ]
    Values found on a device

  13. Duration care [ Time Frame: Day 1 ]
    Time management during cleaning cares

  14. Duration care [ Time Frame: Day 2 ]
    Time management during cleaning cares



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants between 1 and 10 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916835


Contacts
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Contact: Christophe MILESI, PhD 04 67 33 66 09 c-milesi@chu-montpellier.fr

Locations
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France
Hopital Arnaud de Villeneuve- CHU Montpellier Recruiting
Montpellier, France, 34090
Contact: Christophe MILESI, PhD    0467336733    c-milesi@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03916835    
Other Study ID Numbers: UF 7654
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Pediatric Critical ill care or intensive care
anxiety
pain