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

Sponsor
HOSPITAL BRITANICO DE BUENOS AIRES
Study ID
NCT07369258
Status
Recruiting
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Conditions

  • Critical Illness
  • Delirium

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Personalized Music — OTHER
    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.
  • Relaxing Music — OTHER
    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.
  • Standard of Care — OTHER
    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.

Study Details

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 Dates

First listed
Jan 27, 2026
Start date
Feb 2, 2026
Status verified
Feb 2026
Primary completion
Oct 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
330 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Control
    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.
  • Experimental: Relaxing Music
    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.
  • Experimental: Personalized Music
    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.

Primary Outcome Measure

Days Alive and Free of Delirium and Coma [ Time Frame: From randomization up to Day 7 ]

Central Contacts

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