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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
Full description
This randomized controlled clinical trial evaluates the effects of a musical intervention on hormonal and inflammatory biomarkers in critically ill adults receiving invasive mechanical ventilation. The study is conducted in the intensive care unit of a tertiary hospital in Spain.
Participants:
Eligible patients are adults who are intubated, mechanically ventilated, equipped with an arterial catheter, adequately sedated, and not experiencing pain during the intervention period. Patients are enrolled consecutively and randomly assigned to one of two groups.
Interventions:
The intervention group receives a structured music session delivered through headphones in addition to usual ICU care. The control group receives usual ICU care and remains undisturbed for the same duration. The intervention does not interfere with routine clinical procedures.
Outcomes and Variables:
Primary outcomes include serum cortisol, prolactin, and interleukin-6 levels as indicators of hormonal and inflammatory responses. Secondary outcomes include physiological parameters related to hemodynamic status. All variables are measured at three time points: before the intervention, during the intervention period, and immediately after the intervention.
Data Collection and Analysis:
Biological samples and physiological measurements are collected by trained ICU staff following standardized procedures. Descriptive statistics are calculated for all variables. Normality and homoscedasticity are assessed prior to comparative analyses. When required, post-hoc tests are applied. Statistical significance is defined as p ≤ 0.05. No inferential statistical analyses were performed for ClinicalTrials.gov; results are presented descriptively according to PRS requirements.
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Inclusion and exclusion 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.
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110 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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