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
|Condition or disease||Intervention/treatment||Phase|
|Music Therapy Critical Care Analgesia Ventilators, Mechanical||Other: Music||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|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.|
|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|
Patients will received 30 minutes of classical music 3 times per day . Music will be delivered with noise cancellation headphones.
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 Name: Noise cancellation
No Intervention: Control
Patients will receive standard of care.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
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
|Stollery Children's Hospital|
|Edmonton, Alberta, Canada, T6G2B3|
|Principal Investigator:||Gonzalo Garcia Guerra, MD, MSc||University of Alberta|