RecruitingNot ApplicableNCT07369258

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


Sponsor

HOSPITAL BRITANICO DE BUENOS AIRES

Enrollment

330 participants

Start Date

Feb 2, 2026

Study Type

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

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Personalized Music, Relaxing Music, and others for people with critical illness and delirium. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPersonalized Music

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.

OTHERRelaxing Music

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.

OTHERStandard of Care

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)

Hospital Británico de Buenos Aires

Buenos Aires, Buenos Aires F.D., Argentina

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NCT07369258


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