Decreasing delirium through music listening (DDM) in critically ill, mechanically ventilated older adults in the intensive care unit: a two-arm, parallel-group, randomized clinical trial

• Published in: Current controlled trials in cardiovascular medicine 2022-07, Vol.23 (1), p.576-576, Article 576
• Main Authors: Seyffert, Sarah, Moiz, Salwa, Coghlan, Matthew, Balozian, Patil, Nasser, Jason, Rached, Emilio Abi, Jamil, Yasser, Naqvi, Kiran, Rawlings, Lori, Perkins, Anthony J, Gao, Sujuan, Hunter, J. Downs, Khan, Sikandar, Heiderscheit, Annie, Chlan, Linda L, Khan, Babar
• Format: Article
• Language: English
• Subjects: Acute respiratory failure; Alzheimer's disease; Anesthesia; Brain research; Care and treatment; Clinical trials; Cognition; Complications and side effects; Consent; Delirium; Dementia; Evaluation; Generalized anxiety disorder; Headphones; Hospitals; Intensive care; Intervention; Listening; Mechanical ventilation; Music; Music therapy; Neuropsychology; Older people; Patient outcomes; Patients; Post-intensive care syndrome; Questionnaires; Study Protocol; Ventilators
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-022-06448-w

Background Delirium is a highly prevalent and morbid syndrome in mechanically ventilated intensive care unit (ICU) patients. Music is a promising non-pharmacological intervention with beneficial effects on anxiety and stress, while its effects on delirium duration and severity are not well understood. Methods/design Our study is a two-arm, randomized parallel-group, clinical trial to evaluate the efficacy of music intervention compared to a silence-track attention control on delirium/coma duration in mechanically ventilated critically ill older adults. One hundred sixty mechanically ventilated adults 50 years of age or older will be randomized to one of two arms within 72 h of ICU admission: (1) 1-h music listening sessions twice daily through noise-canceling headphones, or (2) 1-h sessions of a silence track twice daily through noise-canceling headphones. Our primary aim is to compare delirium/coma-free days after randomization during the 7-day study intervention phase using the Confusion Assessment Method for the ICU (CAM ICU) and the Richmond Agitation Sedation Scale (RASS) for delirium and coma. Secondary outcomes include pain and anxiety evaluated twice daily during the intervention phase and throughout the duration of ICU stay using the Critical Care Pain Observation Tool (CPOT) and visual analog scale-anxiety (VAS-A). Enrolled participants will be followed after hospital discharge to further measure cognition as well as screening for depression and anxiety using the following telephone-based instruments: Indiana University Telephone-Based Assessment of Neuropsychological Status (IU TBANS), Patient Health Questionnaire-9 (PHQ-9), and Generalized Anxiety Disorder-7 (GAD-7). Discussion This randomized clinical trial will measure the efficacy of a music listening intervention for delirium and coma duration early in the intensive care unit among older adults. Trial registration. ClinicalTrials.gov. NCT04182334. Keywords: Delirium, Music, Post-intensive care syndrome, Acute respiratory failure, Mechanical ventilation, Cognition, Intensive care unit, Pain, Anxiety