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Completed

NCT Number: NCT03916835

MUSIDORE PED Study

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.

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Key information

Age range

6 month–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Arnaud de Villeneuve- CHU Montpellier

Montpellier, 34090, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: MUSIDORE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 16, 2019
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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