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Clinical Application of Listening to Music to Prevent Delirium in the Intensive Care Unit

Key facts

Who runs it
HOSPITAL BRITANICO DE BUENOS AIRES
Where
Argentina1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
330 people, planned
Started
2 Feb 2026
Expected to end
31 Jan 2027
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Personalized Music
  • Relaxing Music
  • Standard of Care
Record updated
4 February 2026

Who can take part

Age
65 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • 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)

Who cannot take part

  • Positive CAM-ICU prior to randomization
  • 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)
  • Suspected or confirmed intoxication with drugs or alcohol at admission
  • 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)
  • Unresolved auditory or visual impairment
  • Uncontrolled psychiatric disease (at least one acute episode requiring intervention in the last 6 months)
  • 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
  • Richmond Agitation-Sedation Scale (RASS) score < -2 or > +2 at the time of randomization
  • Inability of the patient or legal representative to provide informed consent
  • Patients with imminent death, end-of-life care, or limitation of therapeutic effort

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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:

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* 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.

The 3 groups in the trial

  • ControlExisting treatment, for comparison

    Patients receive the institutional Standard of Care (ABCDEF Bundle) for delirium prevention. Participants and families are asked to avoid the use of music devices during the fixed 7-day study window; however, music use is not actively prohibited if requested by the patient or occurs using personal devices. Any such exposure is recorded as protocol deviation ("contamination"), including estimated duration (minutes), source, and type of exposure.

    Treatment: Standard of Care

  • Relaxing MusicTreatment being tested

    In addition to Standard of Care, patients receive 30-minute music sessions twice daily (morning/afternoon) for up to 7 days after randomization. The playlist consists of standardized, slow-tempo (60-80 bpm) instrumental tracks without lyrics.

    Treatment: Relaxing Music and Standard of Care

  • Personalized MusicTreatment being tested

    In addition to Standard of Care, patients receive 30-minute music sessions twice daily (morning/afternoon) for up to 7 days after randomization. The playlist consists of songs selected by the patient or proxy based on personal preferences to evoke positive emotions.

    Treatment: Personalized Music and Standard of Care

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Music to Prevent Delirium: A Prospective, Randomized, Controlled, Three-Arm Parallel-Group Clinical Trial in an Argentine Intensive Care Unit
Record updated
4 February 2026