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
Seyffert S, Moiz S, Coghlan M, Balozian P, Nasser J, Rached EA, Jamil Y, Naqvi K, Rawlings L, Perkins AJ, Gao S, Hunter JD, Khan S, Heiderscheit A, Chlan LL, Khan B
Trials · 17 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Organización sin fines de lucro
- Foundation for the National Institutes of Health
- Subvenciones
- Foundation for the National Institutes of Health (1R01AG067631-01)
Según 1 financiador declarado y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2022-07-19 · Trials · vol. 23 · número 1 · pág. 576
- Editorial
- Springer Science+Business Media
- Citado
- 23 citas · más que el 93% de estudios similares · 3.4× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 23 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY
- Áreas de investigación
- Intensive Care Unit Cognitive Disorders · Music Therapy and Health · Nosocomial Infections in ICU
- Palabras clave
- delirium, music listening, non-pharmacological treatment, mechanical ventilation, older adults, intensive care unit, coma, pain, anxiety, cognitive function, depression
- MeSH
- humans, delirium, pain, critical illness, respiration, artificial, music, aged, intensive care units
16 autores
- Sarah Seyffert🇺🇸 · autor de correspondenciaIndiana University Indianapolis; Indiana University School of Medicine
- Salwa Moiz🇺🇸Regenstrief Institute
- M.A. Coghlan🇺🇸Indiana University Indianapolis; Indiana University School of Medicine
- Patil Balozian🇱🇧Lebanese American University
- Jason Nasser🇱🇧Lebanese American University
- Emilio Abi Rached🇱🇧Lebanese American University
- Yasser Jamil🇱🇧Lebanese American University
- Kiran Naqvi🇺🇸Regenstrief Institute
- Lori Rawlings🇺🇸Regenstrief Institute
- Anthony J. PerkinsIndiana University School of Medicine
- Sujuan GaoIndiana University School of Medicine
- J. Downs Hunter
- Sikandar Khan🇺🇸Regenstrief Institute; Indiana University Indianapolis; Indiana University School of Medicine
- Annie Heiderscheit🇺🇸Augsburg University
- Linda L. Chlan🇺🇸Mayo Clinic
- Babar Ali Khan🇺🇸Regenstrief Institute; Indiana University Indianapolis; Indiana University School of Medicine
Resumen
El texto original del estudio, en el idioma en que se publicó.
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 .
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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