Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
NCT07369258

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

Led by HOSPITAL BRITANICO DE BUENOS AIRES · Updated on 2026-02-04

330

Participants Needed

1

Research Sites

51 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 years or older
  • Negative Confusion Assessment Method for the ICU (CAM-ICU) at the time of randomization
  • Expected ICU stay of at least 48 hours based on clinical judgment at admission
Not Eligible

You will not qualify if you...

  • Positive CAM-ICU prior to randomization
  • Acute primary central nervous system problems causing altered consciousness or preventing cognitive assessment
  • Severe chronic cognitive impairment or advanced dementia needing permanent help with daily activities
  • Unresolved hearing or vision problems
  • Suspected or confirmed drug or alcohol intoxication at admission
  • Uncontrolled psychiatric illness requiring intervention in the last 6 months
  • Richmond Agitation-Sedation Scale score less than -2 or greater than +2 at randomization
  • Medical issues preventing safe use of headphones (e.g., burns, skull fracture, skin lesions)
  • Inability to communicate effectively due to language difficulties
  • Inability of patient or legal representative to give informed consent
  • Patients near death, receiving end-of-life care, or with limits on treatment efforts

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital Británico de Buenos Aires

Buenos Aires, Buenos Aires F.D., Argentina, C1280AEB

Actively Recruiting

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Research Team

S

Sebastián Consalvo, MD

CONTACT

F

Facundo J Gutiérrez, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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