Music Therapy During NIV Implantation in Pediatric Intensive Care Units
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 17
SponsorUniversity Hospital, Montpellier
About this trial
Non-invasive ventilation makes it possible to avoid intubation and improve patients' quality of life. However, pain is associated with discomfort and could lead to failure of this technique.
The aim of this study is to measure the effectiveness of music therapy on pain levels during non-invasive ventilation in critically ill children.
To this end, a pain score (Face Legs Activity Cry Consolability FLACC) will be assessed by raters blinded to the randomization arm during NIV initiation.
The FLACC score will be compared before and during implementation of NIV between two groups: a control group (without music therapy) and an experimental group (with music therapy).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 0 to 17 inclusive
Children hospitalized in pediatric intensive care unit
Indication for NIV
Disqualifiers
- Severe deafness
Clinical condition requiring immediate initiation of NIV
Refusal to allow the child to be photographed
Child not assessable by FLACC score (paralysis of lower limbs, etc.)
Trial design
Design model
Parallel
Treatments tested in this trial
Music Therapy
Other interventionThis procedure is carried out using headphones installed in the child's ears. The music will be activated if the child is in the Music group, and will not be activated but present if the child is not in the Music group. NIV implementation will begin after 10 min of listening. The listening period will continue until the nadir period (when the music is slowest, for maximum relaxation), until 10 min after the start of the NIV.
Setting Up NIV
Procedure/SurgeryNon invasive ventilation is set up in several stages, with the help of at least two caregivers. The patient will be placed in a half-seated position or seated. Installation begins with the placement of the non invasive ventilation mask harness around the child's head, followed by the application of the mask to the face, held by a caregiver. Once the mask has been applied, ventilation is started by connecting the non invasive ventilation circuit to the mask. The harness is then tightened by the second caregiver.
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: Non invasive ventilation setting with Music TherapyExperimental treatment 2 interventions
Group B: Non invasive ventilation setting without Music TherapySham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain variation before and during non invasive ventilation setting with and without music therapy.
FLACC (Face Legs Activity Cry Consolability) : The main assessment tool is a simple, rapid behavioral pain assessment scale, commonly used in the pediatric intensive care unit. For each item, 3 possible scores: 0 or 1 or 2; the total score is from 0 (no pain) to 10 (severe pain). The primary outcome is variation of the Face Legs Activity Cry Consolability (FLACC) score (range, 0-10) comparing before and during non invasive ventilation setting. The first FLACC score evaluation will be just before the beginning of music. The Second FLACC score evaluation will be during the non invasive ventilation setting. FLACC score evaluation over a 10-minute period, with selection of the highest score for each item during the evaluation period FLACC scores' evaluation will be done from videotape records without by 2 investigators The FLACC score will be determined blindly by two assessors who did not participate in the care, using the video taken when the NIV was set up.
Time frame
assessment for 10 minutes before NIV start-up and for 10 minutes during NIV installationSecondary outcomes
1
Pain variation during and after non invasive ventilation setting with and without music therapy. the highest score for each parameter will be selected for each evaluation period of 10 minutes
FLACC (Face Legs Activity Cry Consolability) : The main assessment tool is a simple, rapid behavioral pain assessment scale, commonly used in the pediatric intensive care unit. For each item, 3 possible scores: 0 or 1 or 2; the total score is from 0 (no pain) to 10 (severe pain). The primary outcome is variation of the Face Legs Activity Cry Consolability (FLACC) score (range, 0-10) comparing before and during non invasive ventilation setting. The first FLACC score evaluation will be just before the beginning of music. The Second FLACC score evaluation will be during the non invasive ventilation setting. FLACC scores' evaluation will be done from videotape records without by 2 investigators The FLACC score will be determined blindly by two assessors who did not participate in the care, using the video taken when the NIV was set up.
Time frame
assessment for 10 minutes during NIV installation and for 10 minutes after NIV start-up2
Physiological data variations between the 2 groups: HR
An initial reading will be taken 10 minutes before NIV start-up, during start-up and 10 minutes afterwards. HR: heart rate in beats per minute the highest score for each parameter will be selected for each evaluation period of 10 minutes
Time frame
assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up3
Physiological data variations between the 2 groups: FR
An initial reading will be taken 10 minutes before NIV start-up, during start-up and 10 minutes afterwards. FR: respiratory rate in inhalations per minute the highest score for each parameter will be selected for each evaluation period of 10 minutes
Time frame
assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-up4
Physiological data variations between the 2 groups: SBP
An initial reading will be taken 10 minutes before NIV start-up, during start-up and 10 minutes afterwards. SBP: systolic blood pressure in millimeters of mercury mmHg the highest score for each parameter will be selected for each evaluation period of 10 minutes
Time frame
assessment for 10 minutes before NIV start-up, for 10 minutes during NIV installation and for 10 minutes after NIV start-upSponsors and contacts
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Source ClinicalTrials.gov