N/A N=110 Randomized Triple-blind Treatment

Musical Intervention and Physiological Stress and Inflammatory Biomarkers in Mechanically Ventilated ICU Patients

Sedation · Critical Illness · Respiration, Artificial · Inflammation · Stress, Physiological

Bottom Line

View on ClinicalTrials.gov: NCT06120660 ↗

Enrolled (actual)

110

Serious AEs

0.0%

Results posted

Mar 2026

Primary outcome: Primary: Levels of Serum Cortisol — 13.13; 15.93; 11.56; 16.07 µg/dL

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Music Therapy (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Oviedo
Primary completion: Jun 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Levels of Serum Cortisol	13.13; 15.93; 11.56; 16.07	—
PRIMARY Levels of Prolactin	46.18; 45.74; 45.20; 46.36	—
PRIMARY Levels of Interleukin 6	148.76; 110.60; 150.30; 111.66	—
SECONDARY Bispectral Index (BIS)	50.07; 51.94; 49.30; 52.83	—
SECONDARY Systolic Blood Pressure	130.38; 134.89; 127.62; 132.36	—
SECONDARY Diastolic Blood Pressure	64.10; 63.07; 63.16; 61.60	—
SECONDARY Heart Rate	75.07; 76.89; 76.52; 76.40	—
SECONDARY Respiratory Rate	17.96; 19.25; 18.12; 18.94	—
SECONDARY Oxygen Saturation	98.49; 98.03; 98.51; 98.02	—
SECONDARY Intracranial Pressure	9.84; 7.00; 9.00; 9.60	—
SECONDARY Sedation Medication Use	0.210; 0.156; 0.210; 0.156; 0.002; 0.001	—

Summary

This randomized clinical trial evaluates the effects of a musical intervention on hormonal and inflammatory biomarkers in sedated adult patients undergoing invasive mechanical ventilation in an intensive care unit. Serum cortisol, prolactin, and interleukin-6 levels are measured before and after the intervention, together with hemodynamic parameters. The aim is to assess whether music modulates physiological stress and inflammatory responses in critically ill patients

Eligibility Criteria

Inclusion Criteria

Adults aged ≥18 years. Admitted to the intensive care unit (ICU) for at least 24 hours. Intubated and undergoing invasive mechanical ventilation. Presence of an arterial catheter and/or central venous catheter. Sedation level corresponding to BIS 40-60. Absence of pain at baseline and during the intervention, defined as a CPOT score = 0 (Critical-Care Pain Observation Tool).

No previous exposure to music therapy or other musical interventions during the current hospital stay.

Exclusion Criteria

Severe neurological disease or injury, including encephalitis, diffuse axonal injury, or other central nervous system pathologies.

Severe psychiatric illness. Suspected or confirmed drug or alcohol intoxication, overdose, withdrawal, or abstinence syndrome.

Hearing impairment that would limit perception of the music intervention. Cranial or skull lesions preventing safe placement of headphones. Limitation of therapeutic effort or expected death within the next 24 hours. Diagnosis of brain death. Inability to obtain informed consent from the legal representative within 72 hours of ICU admission.

Refusal by the responsible attending physician.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06120660). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.