Clinical Application of Listening to Music to Prevent Delirium in the Intensive Care Unit
Music to Prevent Delirium: A Prospective, Randomized, Controlled, Three-Arm Parallel-Group Clinical Trial in an Argentine Intensive Care Unit
HOSPITAL BRITANICO DE BUENOS AIRES
330 participants
Feb 2, 2026
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to learn if listening to music can prevent delirium in older adults admitted to the Intensive Care Unit (ICU). The main questions it aims to answer are: * Does listening to music increase the number of days participants are alive and free of delirium and coma during a 7-day period? * Is personalized music more effective than generic relaxing music? Researchers will compare Personalized Music and Relaxing Music to Standard Care (no study-provided music) to see if the music intervention improves delirium outcomes compared to usual care. Participants will: * Listen to music through headphones twice daily (morning and afternoon) for at least 30 minutes during a 7-day period (intervention groups). * Receive standard ICU care and undergo daily assessments for delirium and level of consciousness.
Eligibility
Inclusion Criteria3
- Age 65 years or older.
- Negative Confusion Assessment Method for the ICU (CAM-ICU) at the time of randomization.
- Expected ICU length of stay of at least 48 hours based on clinical judgement at admission (e.g., need for mechanical ventilation, vasopressors, invasive monitoring).
Exclusion Criteria11
- Positive CAM-ICU prior to randomization.
- Acute primary Central Nervous System pathology (e.g., ischemic or hemorrhagic stroke, traumatic brain injury, meningoencephalitis, intracranial hypertension) presenting with altered sensorium (Glasgow Coma Scale at admission < 14) or focal deficit preventing cognitive assessment (e.g., severe aphasia).
- Severe chronic cognitive impairment or advanced dementia, defined by a known history of severe functional dependence prior to admission (requiring permanent assistance for basic activities of daily living such as feeding or grooming)
- Unresolved auditory or visual impairment.
- Suspected or confirmed intoxication with drugs or alcohol at admission.
- Uncontrolled psychiatric disease (at least one acute episode requiring intervention in the last 6 months).
- Richmond Agitation-Sedation Scale (RASS) score < -2 or > +2 at the time of randomization.
- Medical condition precluding the safe use of headphones (e.g., burns, skull fracture, skin lesions).
- Inability to establish effective communication due to a language disorder or unresolved language barrier.
- Inability of the patient or legal representative to provide informed consent.
- Patients with imminent death, end-of-life care, or limitation of therapeutic effort.
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Interventions
Delivery of music via circumaural headphones (approximately 60-70 dB; comfortable, non-excessive volume). Playlists are curated based on patient or proxy interviews reflecting prior music preferences. Sessions last at least 30 minutes, twice daily, for up to 7 days after randomization.
Delivery via circumaural headphones (approximately 60-70 dB; comfortable, non-excessive volume). Standardized, non-lyrical instrumental tracks (60-80 bpm) designed to induce relaxation. Sessions last at least 30 minutes, twice daily, for up to 7 days after randomization.
Institutional standard of care based on the ABCDEF Bundle for ICU patients: (A) Assess, prevent, and manage pain; (B) Both Spontaneous Awakening Trials (SAT) and Spontaneous Breathing Trials (SBT); (C) Choice of analgesia and sedation; (D) Delirium: Assess, prevent, and manage (including daily monitoring via CAM-ICU); (E) Early mobility and exercise; (F) Family engagement and empowerment. Additionally, participants in this group are permitted to access usual environmental media (e.g., television, spoken-word radio, news) as part of routine care.
Locations(1)
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NCT07369258