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Music Use for Sedation In Critically Ill Children (MUSiCC)

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ClinicalTrials.gov Identifier: NCT03497559
Recruitment Status : Completed
First Posted : April 13, 2018
Last Update Posted : May 13, 2019
Sponsor:
Collaborators:
Women and Children's Health Research Institute, Canada
World Federation of Pediatric Intensive and Critical Care Societies
Information provided by (Responsible Party):
Gonzalo Garcia Guerra, University of Alberta

Brief Summary:
Stress induced by pain and anxiety is common in pediatric intensive care unit (PICU) patients and can impede the delivery of care as well as their recovery. Sedation/analgesia in PICU is usually achieved using narcotics and benzodiazepines. Excessive use of these drugs can put patients at risk for hemodynamic and respiratory instability, prolonged mechanical ventilation, withdrawal symptoms, and delirium. Non-pharmacologic measures for analgesia and anxiolysis may reduce the total medication requirement and their side effects. The use of non-pharmacologic interventions, including music, has been recommended by sedation guidelines for critically ill patients; however, it is not clear how these interventions should be provided. We plan to conduct a pilot 3-arm RCT to determine the feasibility of a music intervention and assess its effects on sedation/analgesia requirements in children admitted to PICU. Children will be randomly assigned to receive music, noise cancellation or control. Music will be delivered by headphones and an iPod. Music will consist on classical music selected by the study's pediatric music therapist. The noise cancellation group will receive the same headphones but without music. Clinical care of the participants, including use of sedation and analgesia drugs, will not be protocolized. Primary outcomes of this pilot trial is feasibility. Secondary outcomes are drug requirements for sedation and analgesia, and incidence of delirium. These requirements will be captured as a daily intensity score and intermittent dose (PRN) frequency. Mixed-effects models will be used to analyze the effect of the music on sedation/analgesia requirements.

Condition or disease Intervention/treatment Phase
Music Therapy Critical Care Analgesia Ventilators, Mechanical Other: Music Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: iPods with music and no music, same headphones. Patients and parents are blinded to the intervention the same as bedside nurses, data collectors and principal investigators.
Primary Purpose: Treatment
Official Title: Pilot Randomized Controlled Trial on Music Use for Sedation In Critically Ill Children
Actual Study Start Date : March 30, 2018
Actual Primary Completion Date : April 11, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise

Arm Intervention/treatment
Experimental: Music
Patients will received 30 minutes of classical music 3 times per day . Music will be delivered with noise cancellation headphones.
Other: Music
Classical music
Other Name: Noise cancellation

Sham Comparator: Noise cancellation
Patients will received 30 minutes of silent recording 3 times per day . Music will be delivered with noise cancellation headphones.
Other: Music
Classical music
Other Name: Noise cancellation

No Intervention: Control
Patients will receive standard of care.



Primary Outcome Measures :
  1. Feasibility of a music intervention study in critically ill children. Feasibility is defined as a consent rate of 70%. [ Time Frame: 1 year ]
    The primary outcomes is feasibility of a music intervention study in critically ill children. In order to determine feasibility we will collect information on: number of eligible patients, number of patients enrolled, rate of enrollment, time to complete participation, protocol adherence and reasons for protocol deviation.

  2. Feasibility of for enrolment music intervention study in critically ill children. [ Time Frame: 1 year ]
    Feasibility of enrolment is defined as an average enrolment of 5 patients per month.

  3. Feasibility of a music intervention study in critically ill children with a protocol adherence of 80%. [ Time Frame: 1 year ]
    Protocol adherence is defined as receiving the allocated intervention for 30 minutes 3 times/day at least 80% of the time patient remains in the study.


Secondary Outcome Measures :
  1. Effects of music on sedation requirements measured with the Sedation Intensity Score [ Time Frame: 7 days ]
    Information on sedation. Data on sedation requirements are necessary to calculate the sample size for a future, larger, trial. Sedation requirements will be captured as a daily intensity score and intermittent dose (PRN) frequency. The sedative drug intensity score aggregates the amount of sedation/analgesia from different drug classes using a weight-adjusted dose of each sedative administered during 4-hour time blocks.14 Every sedation amount, for each drug, is placed in quartiles created by using the patient data during the time the patient are involved in the study. The values are then summed over the six 4-hour blocks to obtain the daily score. The Sedation Intensity Score is numeric and has no units.

  2. Effect of music on delirium measured with the Cornell Assessment of Pediatric Delirium (CAPD) instrument [ Time Frame: 7 days ]

    Delirium will be assesed twice a day (as per usual care) with the Cornell Assessment of Pediatric Delirium (CAPD) instrument. Those patients with a score > 9 in two consecutive measurements will be considered to have PICU delirium.34

    critically ill children


  3. Effects of music on sedation requirements measured with Sedation frequency (number of intermittent [PRN] doses) [ Time Frame: 7 days ]
    Dose frequency will be captured by the administration of a (PRN) dose of any of the sedative drugs. This way of capturing sedation requirements enables us to account for the administration of different and non-equivalent types of drugs.14 The unit of measurement is average number of doses/4 hours.



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Ages Eligible for Study:   1 Month to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Admitted to the Stollery Children's Hospital PICU/PCICU.
  • Receiving mechanical ventilation for > 24 hours.
  • Parental consent

Exclusion Criteria:

  • Known hearing deficit
  • Major craniotomy-facial abnormality
  • Traumatic Brain injury
  • Infants < 1 month or < 3 kg.
  • Extracorporeal Life Support with neck cannulation.
  • Receiving non-invasive mechanical ventilation.
  • Nor receiving sedation/analgesia.
  • Enrolled in another intervention RCT.

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): NCT03497559


Locations
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Canada, Alberta
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G2B3
Sponsors and Collaborators
University of Alberta
Women and Children's Health Research Institute, Canada
World Federation of Pediatric Intensive and Critical Care Societies
Investigators
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Principal Investigator: Gonzalo Garcia Guerra, MD, MSc University of Alberta
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gonzalo Garcia Guerra, Associate Profesor, University of Alberta
ClinicalTrials.gov Identifier: NCT03497559    
Other Study ID Numbers: RES0036130
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes