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

NCT07369258 | Recruiting

• 1 other identifier: 15667
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Music; Intensive Care Units; Non-pharmacological Interventions; Psychomotor Agitation; Aged; Music Listening; ICU Delirium; RASS; CAM-ICU

Outcome Measures

Primary Outcomes (1)

• Days Alive and Free of Delirium and Coma

  Number of days alive and free of delirium and coma (range 0-7) in a fixed 7-day window (Day 1 = calendar day of randomization). Coma is defined as a Richmond Agitation-Sedation Scale (RASS) score of -3 to -5 (scale range: +4 \[combative\] to -5 \[unarousable\]). Delirium is defined as the presence of delirium assessed by the Confusion Assessment Method for the ICU (CAM-ICU) or by a positive chart review (screening nursing notes for delirium-related keywords); CAM-ICU is not assessed during coma. Assessments are performed daily. A day is "free" only if the patient is alive, has RASS ≥ -2, and is delirium-negative on both CAM-ICU and chart review. ICU discharge order (transfer order) before Day 7: remaining days counted free. Death before Day 7: remaining days counted non-free. Higher values indicate better outcomes.

  From randomization up to Day 7

Secondary Outcomes (14)

• Days with Delirium

  From randomization up to Day 7

• Days with Coma

  From randomization up to Day 7

• Incidence of Delirium

  From randomization up to Day 7

• Mortality During Intervention

  From randomization up to Day 7

• Intensive Care Unit Length of Stay

  From ICU admission to physical ICU discharge, assessed up to 90 days

Other Outcomes (3)

• Total Music Exposure

  From randomization up to Day 7

• Percentage of Completed Sessions

  From randomization up to Day 7

• Incidence of Ear Injury

  From randomization up to Day 7

Study Arms (3)

Control

ACTIVE COMPARATOR

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.

Other: Standard of Care

Relaxing Music

EXPERIMENTAL

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.

Other: Relaxing Music; Other: Standard of Care

Personalized Music

EXPERIMENTAL

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.

Other: Personalized Music; Other: Standard of Care

Interventions

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.

Relaxing Music

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.

Control; Personalized Music; Relaxing Music

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.

Personalized Music

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 years or older.
• Negative Confusion Assessment Method for the ICU (CAM-ICU) at the time of randomization.
• Expected ICU length of stay of at least 48 hours based on clinical judgement at admission (e.g., need for mechanical ventilation, vasopressors, invasive monitoring).

You may not qualify if:

• Positive CAM-ICU prior to randomization.
• Acute primary Central Nervous System pathology (e.g., ischemic or hemorrhagic stroke, traumatic brain injury, meningoencephalitis, intracranial hypertension) presenting with altered sensorium (Glasgow Coma Scale at admission \< 14) or focal deficit preventing cognitive assessment (e.g., severe aphasia).
• Severe chronic cognitive impairment or advanced dementia, defined by a known history of severe functional dependence prior to admission (requiring permanent assistance for basic activities of daily living such as feeding or grooming)
• Unresolved auditory or visual impairment.
• Suspected or confirmed intoxication with drugs or alcohol at admission.
• Uncontrolled psychiatric disease (at least one acute episode requiring intervention in the last 6 months).
• Richmond Agitation-Sedation Scale (RASS) score \< -2 or \> +2 at the time of randomization.
• Medical condition precluding the safe use of headphones (e.g., burns, skull fracture, skin lesions).
• Inability to establish effective communication due to a language disorder or unresolved language barrier.
• Inability of the patient or legal representative to provide informed consent.
• Patients with imminent death, end-of-life care, or limitation of therapeutic effort.

Sponsors & Collaborators

• HOSPITAL BRITANICO DE BUENOS AIRES: lead

Study Sites (1)

Hospital Británico de Buenos Aires

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

RECRUITING

MeSH Terms

Conditions

Critical Illness; Delirium; Psychomotor Agitation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Psychomotor Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sebastián Consalvo, MD

  Hospital Británico de Buenos Aires

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastián Consalvo, MD

CONTACT

+54 9 11 6784 9495; sebasconsalvo@gmail.com

Facundo J Gutiérrez, MD

CONTACT

+54 9 11 2653 5984; gutierrez991@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention (music via headphones), blinding of participants and care providers is not feasible. However, the Outcome Assessor responsible for the daily CAM-ICU and RASS evaluation is blinded to group assignment. To ensure blinding, music devices are not present in the patient's room during the assessment and intervention delivery is recorded in separate study forms (CRFs) rather than the routine medical chart to prevent unblinding via chart review.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Three-arm parallel-group randomized controlled trial with a 1:1:1 allocation ratio

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 27, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

AR (1)