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

NCT07369258 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2026-02-04

No results posted yet for this study

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.

Conditions

  • Critical Illness
  • Delirium

Interventions

OTHER

Personalized 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.

OTHER

Relaxing 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.

OTHER

Standard 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.

Sponsors & Collaborators

  • HOSPITAL BRITANICO DE BUENOS AIRES

    lead OTHER

Principal Investigators

  • Sebastián Consalvo, MD · Hospital Británico de Buenos Aires

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-02
Primary Completion
2026-10-31
Completion
2027-01-31

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07369258 on ClinicalTrials.gov