Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
ID07369258

Music to Prevent Delirium: A Randomized Controlled Trial Comparing Personalized and Relaxing Music to Standard Care in Older Adults in the ICU

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

330

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research investigates whether listening to music can help prevent delirium in older adults admitted to the Intensive Care Unit (ICU). It specifically compares the effects of personalized music and relaxing instrumental music to standard ICU care without study-provided music. The study focuses on the number of days patients are alive and free from delirium or coma during the first seven days after randomization. Participants are randomly assigned to one of three groups: personalized music, relaxing music, or standard care. Those in the music groups listen to music through headphones twice daily (morning and afternoon) for at least 30 minutes over a 7-day period. Personalized music playlists are based on patient or proxy preferences to evoke positive emotions, while relaxing music playlists consist of slow-tempo instrumental tracks without lyrics. The standard care group receives usual ICU care and is asked to avoid music devices during the study period. Throughout the study, participants receive daily assessments for delirium and level of consciousness using validated tools. Research staff monitor adherence to the music sessions and record total music exposure. The primary outcome is the number of days alive and free of delirium and coma within seven days after randomization. Secondary outcomes include incidence and duration of delirium, ICU length of stay, medication use, anxiety levels, physical restraints, and ventilator-free days. The total participation includes up to seven days of intervention and monitoring in the ICU.

CONDITIONS

Brief 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 randomization
  • Expected ICU stay of at least 48 hours based on clinical judgement at admission
Not Eligible

You will not qualify if you...

  • Positive CAM-ICU prior to randomization
  • Acute primary Central Nervous System pathology with altered consciousness or cognitive assessment barriers
  • Severe chronic cognitive impairment or advanced dementia requiring full assistance
  • Unresolved hearing or vision impairments
  • Suspected or confirmed intoxication with drugs or alcohol at admission
  • Uncontrolled psychiatric disease with recent acute episode
  • Richmond Agitation-Sedation Scale (RASS) score less than -2 or greater than +2 at randomization
  • Medical condition preventing safe use of headphones
  • Inability to communicate effectively due to language disorder or barrier
  • Inability to provide informed consent
  • Imminent death, end-of-life care, or limitation of therapeutic effort

AI-Screening

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Your Study Journey

Screening

Duration - Up to 5 days from ICU admission until the patient becomes evaluable with adequate consciousness and negative delirium assessment.

Participants are screened for eligibility to participate in the trial.

Daily screening visits in the ICU

Treatment

Duration - Up to 7 days after randomization or until ICU transfer, death, or withdrawal

Participants receive twice daily 30-minute music sessions using headphones for up to 7 days after randomization to help prevent delirium, or standard care without music intervention for the control group.

Twice daily music sessions during ICU stay for up to 7 days; daily delirium assessments

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

F

Facundo J Gutiérrez, MD

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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