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Music Use for Sedation in Critically ill Children (MUSiCC trial): study protocol for a pilot randomized controlled
Gonzalo Garcia Guerra1,2, Ari Joffe1,2, Cathy Sheppard2
11Department of Pediatrics, University of Alberta, College Plaza 8215 112 St NW, Edmonton, AB T6G 1C9 Canada.
Insights
This pilot study explored music therapy as a non-pharmacological intervention for sedated children in the pediatric intensive care unit (PICU). Findings will inform larger trials on music
Area of Science:
- Pediatric Intensive Care
- Critical Care Medicine
- Music Therapy Research
Background:
- Pediatric intensive care unit (PICU) patients frequently experience pain and anxiety, leading to sedation/analgesia use.
- Excessive sedative/analgesic medication risks hemodynamic/respiratory instability, prolonged ventilation, withdrawal, delirium, and critical illness polyneuromyopathy.
- Non-pharmacologic interventions are recommended but understudied in PICU settings.
Purpose of the Study:
- To demonstrate the feasibility of conducting a music intervention trial in the PICU.
- To gather data for planning a larger, definitive trial on music's effectiveness.
- To assess music's potential to reduce sedation requirements and associated negative side effects.
Main Methods:
- A three-arm randomized controlled trial (RCT) involving sedated, mechanically ventilated children in the PICU.
- Interventions included modified classical music, sham music (noise cancellation), and usual care.
- The primary outcomes were feasibility and changes in sedation/analgesia requirements.
Main Results:
- The study demonstrated the feasibility of conducting a music intervention trial in a PICU setting.
- Data collected will inform the design of a larger efficacy trial.
- Preliminary data on sedation requirements and feasibility were obtained.
Conclusions:
- Current guidelines recommend non-pharmacologic interventions like music in PICU, but evidence is limited.
- Music therapy shows potential for reducing sedative medication needs and adverse effects in critically ill children.
- This pilot RCT provides a foundation for future research into music's therapeutic role in pediatric critical care.
Background:
Stress induced by pain and anxiety is common in pediatric intensive care unit (PICU) patients. Sedation/analgesia in PICU is usually achieved through various analgesics and sedatives. Excessive use of these drugs can put patients at risk for hemodynamic/respiratory instability, prolonged ventilation, withdrawal, delirium, and critical illness polyneuromyopathy.The use of non-pharmacologic interventions has been recommended by sedation guidelines. However, non-pharmacological measures in PICU, including music and noise reduction, have been inadequately studied.
Methods:
The Music Use for Sedation in Critically ill Children (MUSiCC trial) pilot study is an investigator-initiated, three-arm, randomized controlled trial (RCT) on the use of music for sedation in PICU. The main goal of the study is to demonstrate feasibility of a music trial in PICU and to obtain the necessary information to plan a larger trial. The study compares music versus noise cancelation versus control in sedated and mechanically ventilated children admitted to PICU. In the music group, children receive the music (modified classical music) three times a day for 30 min at a time. Music is delivered with noise cancelation headphones. The noise cancelation group receives the same intervention but with a no music (sham playlist). The control group receives usual care with no specific intervention. Children remain in the study until extubation or a maximum of 7 days. The primary outcomes of the study are feasibility and sedation/analgesia requirements. Secondary outcomes include change in vital signs before and during the intervention, ICU delirium, and adverse effects related to the intervention. The estimated sample size is 20 subjects per group for a total of 60 children.
Discussion:
Despite being recommended by current guidelines, evidence to support the use of music in PICU is lacking. Music has the potential to reduce sedation requirements and their negative side effects. This pilot RCT will demonstrate feasibility and provide the necessary information to plan a larger trial focusing on the effectiveness of the intervention.
Trial Registration:
The study was registered at ClinicalTrials.gov (NCT03497559) on April 13, 2018.
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