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

Sarah Seyffert, Salwa Moiz, Matthew Coghlan, Patil Balozian, Jason Nasser, Emilio Abi Rached, Yasser Jamil, Kiran Naqvi, Lori Rawlings, Anthony J Perkins, Sujuan Gao, J Downs Hunter 3rd, Sikandar Khan, Annie Heiderscheit, Linda L Chlan, Babar Khan, Sarah Seyffert, Salwa Moiz, Matthew Coghlan, Patil Balozian, Jason Nasser, Emilio Abi Rached, Yasser Jamil, Kiran Naqvi, Lori Rawlings, Anthony J Perkins, Sujuan Gao, J Downs Hunter 3rd, Sikandar Khan, Annie Heiderscheit, Linda L Chlan, Babar Khan

Abstract

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: Acute respiratory failure; Anxiety; Cognition; Delirium; Intensive care unit; Mechanical ventilation; Music; Pain; Post-intensive care syndrome.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
DDM study flow chart, interventions, and assessments. Abbreviations: CAM-ICU, Confusion Assessment Method for the Intensive Care Unit; CPOT, Critical Pain Observation Tool; RASS, Richmond Agitation-Sedation Scale; VAS-A, visual analog scale-anxiety; IUTBANS, Indiana University Telephone-Based Assessment of Neuropsychological Status; PHQ-9, Patient Health Questionnaire; GAD-7, Generalized Anxiety Disorder Scale
Fig. 2
Fig. 2
Timeline of study events

References

    1. Miller RR, Ely EW, editors. Delirium and cognitive dysfunction in the intensive care unit. Seminars in respiratory and critical care medicine. New York: Thieme; 2006.
    1. Ely E, Inouye SK, Bernard GR, et al. Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (cam-icu) JAMA. 2001;286(21):2703–2710.
    1. Ely EW, Margolin R, Francis J, May L, Truman B, Dittus R, et al. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) Crit Care Med. 2001;29(7):1370–1379.
    1. McNicoll L, Pisani MA, Zhang Y, Ely EW, Siegel MD, Inouye SK. Delirium in the intensive care unit: occurrence and clinical course in older patients. J Am Geriatr Soc. 2003;51(5):591–598.
    1. Thomason JW, Shintani A, Peterson JF, Pun BT, Jackson JC, Ely EW. Intensive care unit delirium is an independent predictor of longer hospital stay: a prospective analysis of 261 non-ventilated patients. Crit Care. 2005;9(4):R375.
    1. Ely E, Shintani A, Truman B, et al. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004;291(14):1753–1762.
    1. Jackson JC, Hart RP, Gordon SM, Shintani A, Truman B, May L, et al. Sixmonth neuropsychological outcome of medical intensive care unit patients. Crit Care Med. 2003;31(4):1226–1234.
    1. Chlan L. Effectiveness of a music therapy intervention on relaxation and anxiety for patients receiving ventilatory assistance. Heart Lung. 1998;27(3):169–176.
    1. Chlan LL, Weinert CR, Heiderscheit A, Tracy MF, Skaar DJ, Guttormson JL, et al. Effects of patient-directed music intervention on anxiety and sedative exposure in critically ill patients receiving mechanical ventilatory support: a randomized clinical trial. JAMA. 2013;309(22):2335–2344.
    1. Han L, Li JP, Sit JW, Chung L, Jiao ZY, Ma WG. Effects of music intervention on physiological stress response and anxiety level of mechanically ventilated patients in China: a randomised controlled trial. J Clin Nurs. 2010;19(7–8):978–987.
    1. Hetland B, Lindquist R, Chlan LL. The influence of music during mechanical ventilation and weaning from mechanical ventilation: a review. Heart Lung. 2015;44(5):416–425.
    1. Korhan EA, Khorshid L, Uyar M. The effect of music therapy on physiological signs of anxiety in patients receiving mechanical ventilatory support. J Clin Nurs. 2011;20(7–8):1026–1034.
    1. Lee CH, Lee CY, Hsu MY, Lai CL, Sung YH, Lin CY, et al. Effects of music intervention on state anxiety and physiological indices in patients undergoing mechanical ventilation in the intensive care unit. Biol Res Nurs. 2017;19(2):137–144.
    1. Mofredj A, Alaya S, Tassaioust K, Bahloul H, Mrabet A. Music therapy, a review of the potential therapeutic benefits for the critically ill. J Crit Care. 2016;35:195–199.
    1. Girard TD, Pandharipande PP, Carson SS, et al. Feasibility, efficacy, and safety of antipsychotics for intensive care unit delirium: the MIND randomized, placebo controlled trial. Crit Care Med. 2010;38:428.
    1. Beaulieu-Boire G, Bourque S, Chagnon F, Chouinard L, Gallo-Payet N, Lesur O. Music and biological stress dampening in mechanically-ventilated patients at the intensive care unit ward—a prospective interventional randomized crossover trial. J Crit Care. 2013;28(4):442–450.
    1. Khan SH, Xu C, Purpura R, Durrani S, Lindroth H, Wang S, et al. Decreasing delirium through music: a randomized pilot trial. Am J Crit Care. 2020;29(2):31–38.
    1. Khan B, Perkins AJ, Campell NL, Gao S, Farber MO, Wang S, et al. Pharmacological management of delirium in the ICU: a randomized pragmatic clinical trial. J Am Geriatr Soc. 2019;67(5):1057–1065.
    1. Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O’Neal PV, Keane KA, et al. The Richmond Agitation-sedation scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002;166(10):1338–1344.
    1. Khan BA, Guzman O, Campbell NL, Walroth T, Tricker J, Hui SL, et al. Comparison and agreement between the Richmond Agitation-sedation scale and the riker sedation-agitation scale in evaluating patients’ eligibility for delirium assessment in the ICU. Chest. 2012;142(1):48–54.
    1. Khan BA, Perkins AJ, Gao S, Hui SL, Campbell NL, Farber MO, et al. The Confusion Assessment Method for the ICU-7 Delirium Severity Scale: a novel delirium severity instrument for use in the ICU. Crit Care Med. 2017;45(5):851–857.
    1. Stubbs T. Experiences and perceptions of music therapy in critical illness. Nurs Times. 2005;101(45):34–36.
    1. Zhang Y, Cai J, An L, Hui F, Ren T, Ma H, et al. Does music therapy enhance behavioral and cognitive function in elderly dementia patients? A systematic review and meta-analysis. Ageing Res Rev. 2017;35:1–11.

Source: PubMed

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

3
Abonnere