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Clinical Practice Protocol of Creative Music Therapy for Preterm Infants and Their Parents in the Neonatal Intensive Care Unit
Published on: January 7, 2020
Music Use for Sedation in Critically ill Children (MUSiCC trial): a pilot randomized controlled trial
Gonzalo Garcia Guerra1,2, Ari R Joffe3,4, Cathy Sheppard4
1Department of Pediatrics, University of Alberta, Room 4-548 11405 87 Avenue, Edmonton, AB, T6G 1C9, Canada. gonzalo.guerra@ahs.ca.
Insights
This pilot study shows that music medicine interventions are feasible in pediatric intensive care units. The trial provided data to plan larger studies on music
Area of Science:
- Pediatric Intensive Care Medicine
- Music Therapy
- Clinical Trial Design
Background:
- Critically ill children in intensive care often require sedation and analgesia.
- Feasibility of non-pharmacological interventions like music therapy in this population is not well-established.
Purpose of the Study:
- To assess the feasibility of a music medicine intervention trial in pediatric intensive care.
- To gather data on sedation and analgesia use for future larger trials.
Main Methods:
- Pilot randomized controlled trial (RCT) involving children aged 1 month to 16 years on mechanical ventilation.
- Patients were randomized to receive classical music, noise cancellation, or usual care.
- Interventions were administered for 30 minutes, three times daily.
Main Results:
- The study enrolled 60 patients with a feasible enrollment rate and acceptable consent rate.
- Protocol adherence exceeded 80%, and no adverse events were reported.
- A statistically significant decrease in heart rate was observed during music intervention, with positive parental feedback on comfort and child settling.
Conclusions:
- Music medicine interventions are feasible in pediatric intensive care settings.
- The pilot study successfully gathered essential data for designing a larger, powered clinical trial.
Objective:
To demonstrate feasibility of a music medicine intervention trial in pediatric intensive care and to obtain information on sedation and analgesia dose variation to plan a larger trial.
Material And Methods:
Pilot randomized controlled trial (RCT) was conducted at the Stollery Children's Hospital general and cardiac intensive care units (PICU/PCICU). The study included children 1 month to 16 years of age on mechanical ventilation and receiving sedation drugs. Patients were randomized in a 1:1:1 ratio to music, noise cancellation or control. The music group received classical music for 30 min three times/day using headphones. The noise cancellation group received the same intervention but with no music. The control group received usual care.
Results:
A total of 60 patients were included. Average enrollment rate was 4.8 patients/month, with a consent rate of 69%. Protocol adherence was achieved with patients receiving > 80% of the interventions. Overall mean (SD) daily Sedation Intensity Score was 52.4 (30.3) with a mean (SD) sedation frequency of 9.75 (7.21) PRN doses per day. There was a small but statistically significant decrease in heart rate at the beginning of the music intervention. There were no study related adverse events. Eighty-eight percent of the parents thought the headphones were comfortable; 73% described their child more settled during the intervention.
Conclusions:
This pilot RCT has demonstrated the feasibility of a music medicine intervention in critically ill children. The study has also provided the necessary information to plan a larger trial.
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