- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03497559
Music Use for Sedation In Critically Ill Children (MUSiCC)
Pilot Randomized Controlled Trial on Music Use for Sedation In Critically Ill Children
Study Overview
Status
Intervention / Treatment
Detailed Description
Aim and Objectives Overall Research Question Does music reduce sedation requirements in critically ill children? Purpose statement We plan to conduct a pilot randomized controlled trial (RCT) to determine the feasibility of a pediatric music medicine trial, and to study the effects of music on sedation requirements in children admitted to the pediatric intensive care unit (PICU).
Objectives: a) To demonstrate the feasibility of a music RCT in pediatric critical care; b) To estimate the effect of music on the sedation requirements of critically ill children; c) to obtain information about standard deviation and mean treatment effect for future sample size calculation for a larger trial.
Hypothesis:
We hypothesize that: a) A RCT of music in critically ill children will be feasible; b) Music will result in a 20 % reduction in sedation requirements.
Methodology Study design: We propose a pilot 3 arm RCT. Randomization will be done by a computer-based program to ensure allocation concealment. A total of 30 patients will be randomly assigned in a 1:1:1 ratio to receive music, noise cancellation or control.
Setting: Pediatric Intensive Care Units (Cardiac and General) at the Stollery Children's Hospital, Edmonton, Alberta.
Study Population: critically ill children on mechanical ventilation and receiving sedation and/or analgesia.
Intervention After consent and randomization, patients will be started on the assigned intervention (music/noise cancellation/control) 24-48 hours after admission to the PICU. Based on the neonatal and adult studies, in the music and noise cancellation groups the intervention will be delivered during 30 minutes, at least 3 times a day. The control group will receive usual care. Music will be delivered with the use of noise cancellation headphones and an iPod touch (Apple, California). Music selection will be chosen based on the patient's age. Classical music has been selected by a pediatric music therapist based on its observed properties to settle and calm children. In the noise cancellation group the intervention will be provided with the same headphones connected to an iPod with a silent recording. Children will be assessed with the Sedation behavior scale (SBS) before and during the intervention.29 Signs of agitation or an increase in the SBS will indicate failure of the intervention. Patients will remain on protocol for a maximum of 7 days as long as they are on invasive mechanical ventilation. A parent survey will be conducted at the end of the study. This survey will be conducted on paper or electronically (REDCap, Research Electronic Data Capture) as per the parents' preference.
Concomitant interventions: Clinical care will not be protocolized, and will be according to usual care. Sedative administration will not be directed by the study protocol; it will be up to the attending PICU physician. Assessment of the patients' sedation status and withdrawal symptoms will be conducted every 6 hours by the bedside nurse. Sedation status will be assessed with the use of the SBS while withdrawal will be assessed with the Withdrawal Assessment Tool (WAT-1) score; both are well validated tools .29-32 Demographic variables: To assess if the groups are comparable, including known risk factors, we will record the following: demographic variables (sex, weight, age, diagnosis, operative status, Paediatric Risk of Mortality (PRISM) score, inotrope score, Paediatric logistic organ dysfunction (PELOD) score, baseline SBS, invasive procedures, presence of invasive lines and tubes).
Outcome variables: Feasibility, sedation requirements and delirium. Adverse events Adverse events such as significant negative change in vital signs and/or any other sign of intolerance (agitation) to the intervention will be recorded. We will also record any skin or ear problems (pressure injuries) thought to be associated with the use of headphones.
Study procedures: Patients admitted to the Stollery Children's Hospital PICU and needing mechanical ventilation will be screened for eligibility and approached for consent. After consent, patient demographics will be recorded. Eligible patients will be randomly assigned in a 1:1:1 ratio to the music, the noise cancellation or the control group. During randomization we will stratify patients by age. As a patient qualifies for the trial, a study number and a randomization number will be assigned. Based on the randomization code the research nurse will proceed with one of the interventions, or control, as described above.
Masking: The research nurse will provide the iPods with music or silent recording based on group allocation and will not disclose this information to the healthcare team or the family. However, it is impossible to blind the use of headphones vs. control. The statistician analyzing the data will be blinded to the group allocation.
Sample size justification: The primary outcome used to determine sample size for a future larger RCT is daily Sedation Intensity Score (SIS). The minimal clinically important difference determined by our survey is a reduction in sedation requirements of 20%.8 This pilot study including 10 patients in each group (total 30 patients) will allow us to obtain pediatric information to calculate a sample size for the larger trial.
Analysis Baseline characteristics will be analyzed by descriptive methods. Analysis will be conducted on intention to treat basis and as per protocol. Mixed-effects models will be used to analyze the primary effect of the music on sedation requirements. Statistical tests will be 2-sided with 0.05 level of significance.
Data collection: Variables will be recorded in an anonymized database using REDCap, Research Electronic Data Capture.34
Expected outcomes and Impact This pilot study is a necessary first step toward the conduct of a larger music trial in critically ill children. To obtain funding from major agencies we need to demonstrate the tolerability and feasibility of the intervention and patient recruitment at our centre. This pilot study will also allow formal sample size calculation for a larger trial and will allow us to obtain feedback from major stakeholders including families.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G2B3
- Stollery Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / 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.
|
Classical music
Other Names:
|
SHAM_COMPARATOR: Noise cancellation
Patients will received 30 minutes of silent recording 3 times per day .
Music will be delivered with noise cancellation headphones.
|
Classical music
Other Names:
|
NO_INTERVENTION: Control
Patients will receive standard of care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
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.
|
1 year
|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
7 days
|
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 |
7 days
|
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.
|
7 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gonzalo Garcia Guerra, MD, MSc, University of Alberta
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RES0036130
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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