Gonzalo Garcia Guerra1,2, Ari R Joffe3,4, Cathy Sheppard4, Krista Hewson5, Irina A Dinu6, Morteza Hajihosseini6, Allan deCaen3,4, Hsing Jou3,4,7, Lisa Hartling3, Sunita Vohra3,4,7. 1. Department of Pediatrics, University of Alberta, Room 4-548 11405 87 Avenue, Edmonton, AB, T6G 1C9, Canada. gonzalo.guerra@ahs.ca. 2. Stollery Children's Hospital, Edmonton, AB, Canada. gonzalo.guerra@ahs.ca. 3. Department of Pediatrics, University of Alberta, Room 4-548 11405 87 Avenue, Edmonton, AB, T6G 1C9, Canada. 4. Stollery Children's Hospital, Edmonton, AB, Canada. 5. Department of Educational Psychology, University of Alberta, Edmonton, AB, Canada. 6. School of Public Health, University of Alberta, Edmonton, AB, Canada. 7. Integrative Health Institute, University of Alberta, Edmonton, AB, Canada.
Abstract
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.
RCT Entities:
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 illchildren. The study has also provided the necessary information to plan a larger trial.
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