20 To randomize patients, we used permuted block randomization with various block sizes and computer-generated random numbers. If initial consent was obtained from the LAR, the patient was approached for reconsent once they were able to communicate. We obtained consent from the patient or, if the patient was unable to provide consent, from their legally authorized representative (LAR). Patients were excluded if they had neurologic injury, chronic neurologic disease, or uncorrected hearing or vision impairments were intoxicated by or in withdrawal from alcohol or drugs were in a coma after cardiac arrest, pregnant or nursing, or incarcerated or the primary team did not consider the patient appropriate for the study (eg, patient soon enrolling in comfort care). We excluded patients who had been receiving mechanical ventilation for longer than 48 hours because delirium develops early during the ICU stay, and our intervention may have preventive and therapeutic effects. In brief, we included English-speaking adult patients (≥ 18 years old) admitted to the ICU and receiving mechanical ventilation for at least 24 hours but not more than 48 hours. 20 The Indiana University institutional review board reviewed and approved the study. We conducted a 3-arm, single-blind, randomized controlled clinical trial details of the protocol have been published elsewhere.
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