Music Use for Sedation In Critically Ill Children
Condition: Music Therapy; Critical Care; Analgesia; Ventilators, Mechanical
MeSH terms: Critical Illness
Study type: Interventional

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.
    

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.
    

Intervention name(s): Music
Intervention type(s): Other
Intervention description(s): Classical music
Other intervention name(s): Noise cancellation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment