Clinical Application of Listening to Music to Prevent Delirium in the Intensive Care Unit
Recruiting now · Not applicable
Conditions studied: Critical Illness, Delirium
In brief
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.
Key facts
- Study ID
- NCT07369258
- Run by
- HOSPITAL BRITANICO DE BUENOS AIRES
- People needed
- 330
- Starts
- 2026-02-02
- Expected to finish
- 2027-01-31
- Last updated by the study team
- 2026-02-04
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Hospital Británico de Buenos Aires — Buenos Aires, Buenos Aires F.D., Argentina (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.