Music Use for Sedation In Critically Ill Children

NCT03497559 | Completed

• 1 other identifier: RES0036130
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Music Therapy; Critical Care; Analgesia; Ventilators, Mechanical

Outcome Measures

Primary Outcomes (3)

• Feasibility of a music intervention study in critically ill children. Feasibility is defined as a consent rate of 70%.

  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.

  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%.

  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 Outcomes (3)

• Effects of music on sedation requirements measured with the Sedation Intensity Score

  7 days

• Effect of music on delirium measured with the Cornell Assessment of Pediatric Delirium (CAPD) instrument

  7 days

• Effects of music on sedation requirements measured with Sedation frequency (number of intermittent [PRN] doses)

  7 days

Study Arms (3)

Music

EXPERIMENTAL

Patients will received 30 minutes of classical music 3 times per day . Music will be delivered with noise cancellation headphones.

Other: Music

Noise cancellation

SHAM COMPARATOR

Patients will received 30 minutes of silent recording 3 times per day . Music will be delivered with noise cancellation headphones.

Other: Music

Control

NO INTERVENTION

Patients will receive standard of care.

Interventions

Music OTHER

Classical music

Also known as: Noise cancellation

Music; Noise cancellation

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead
• Women and Children's Health Research Institute, Canada: collaborator
• World Federation of Pediatric Intensive and Critical Care Societies: collaborator

Study Sites (1)

Stollery Children's Hospital

Edmonton, Alberta, T6G2B3, Canada

Location

Related Publications (1)

• Garcia Guerra G, Joffe A, Sheppard C, Hewson K, Dinu IA, de Caen A, Jou H, Hartling L, Vohra S; Canadian Critical Care Trials Group. Music Use for Sedation in Critically ill Children (MUSiCC trial): study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2020 Feb 25;6:31. doi: 10.1186/s40814-020-0563-x. eCollection 2020.

  PMID: 32128249 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Gonzalo Garcia Guerra, MD, MSc

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Profesor

Model Details: Double blind randomized controlled trial

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 13, 2018
• Study Start: March 30, 2018
• Primary Completion: April 11, 2019
• Study Completion: April 30, 2019
• Last Updated: May 13, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)