Live and recorded music interventions for management of delirium symptoms in acute geriatric patients: Protocol for a randomized feasibility trial

Abstract

Introduction: Delirium is an acute alteration in attention, awareness, arousal, and cognition, precipitated by a sudden illness and highly prevalent in older, frail and acutely hospitalized patients. It is associated with poor outcomes, and few effective treatment alternatives. Non-pharmacological interventions and music show promising effects, warranting further research. This pilot randomized repeated measures trial aims to test feasibility of the trial methodology, acceptability, fidelity and safety of the music interventions, suitability of the effect-outcomes. and preliminary effectiveness. Method: Acute geriatric patients with delirium or subsyndromal delirium will be randomized to Preferred Recorded Music (n = 30) or Preferred Live Music (n = 30), delivered for 30 minutes, over three consecutive days. Planned feasibility outcomes will comprise recruitment rate, retention and attrition rates, percentage of adherence, deviations rates, and success of treatment fidelity. Clinical outcomes will include: (a) trajectory of delirium symptoms: level of arousal as assessed by Observational Scale of Level of Arousal (OSLA) and modified Richmond Agitation Sedation Scale (mRASS); attention, assessed using backwards tests and digit span tests; orientation and short-term memory, assessed using recall tasks and orientation questions from Memorial Delirium Assessment Scale, (b) duration of delirium, (c) length of hospital stay, and (d) use of PRN medication (benzodiazepines and antipsychotics). Discussion: The trial will provide results needed to design a subsequent sufficiently powered RCT, informing on the expected recruitment, feasibility and acceptability of the interventions and assessments and preliminary effectiveness.