Abstract
Personalized music interventions and earplugs have shown promise in preventing intensive care unit (ICU) delirium, but evidence on their combined effects is limited. To evaluate the feasibility and preliminary effects of personalized music intervention combined with earplugs (MUSE) and personalized music intervention (PMI) on delirium prevention and clinical outcomes in mechanically ventilated patients. In this randomized controlled trial, 63 participants were assigned to MUSE, PMI, or usual care (UC). Delirium was assessed during each nursing shift using the Intensive Care Delirium Screening Checklist, alongside measures of pain, sedation, sleep, and clinical outcomes. The delirium incidence was 50% in the UC group, 25% in the PMI group, and 33% in the MUSE group. The median number of delirium or coma-free days was 7 (interquartile range [IQR] = 4-7) in the PMI group, 5 (IQR = 4-7) in the MUSE group, and 5 (IQR = 3-7) in the UC group. No significant between-group differences in either primary or secondary outcomes were identified. The exploratory post hoc subgroup analysis indicates that age may influence the effects of treatment on delirium. In this pilot study, neither MUSE nor PMI had significant effects in reducing delirium incidence among patients undergoing mechanical ventilation when compared with UC. However, PMI appeared more effective at preventing delirium relative to MUSE and UC, and the potential additional benefit of earplugs remains uncertain in this study. This study is registered at www.clinicaltrials.gov. Trial registration number is NCT04065256.