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

N/ACompletedNCT06120660

University of Oviedo110 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Levels of Serum Cortisol

Serum cortisol levels were measured from venous blood samples collected immediately before (minute 0) and after (minute 60) the music intervention or standard care using standard laboratory assays. This measure reflects the acute physiological stress response.

Time frame: Only one intervention per person will be performed. Serum levels will be measured before and after the intervention (minute 0 and 60).

Levels of Prolactin

Serum prolactin levels were measured from venous blood samples obtained immediately before (minute 0) and after (minute 60) the intervention using standard laboratory immunoassays. This biomarker reflects neuroendocrine stress response and can indicate changes related to the music intervention.

Time frame: Only one intervention per person will be performed. Serum levels will be measured before and after the intervention. That is, at minute 0 and 60.

Levels of Interleukin 6

Serum interleukin-6 (IL-6) levels were measured from venous blood samples collected immediately before (minute 0) and after (minute 60) the intervention using standard laboratory immunoassays. IL-6 is a pro-inflammatory cytokine and its serum concentration reflects acute systemic inflammatory activity.

Time frame: Only one intervention per person will be performed. Serum levels will be measured before and after the intervention. That is, at minute 0 and 60.

Secondary Outcomes

Bispectral Index (BIS)

The Bispectral Index (BIS) is a processed electroencephalographic scale used to quantify the depth of sedation or anesthesia. BIS values range from 0 to 100, where 100 represents a fully awake state and 0 represents EEG silence. Lower scores indicate deeper sedation, while higher scores indicate lighter sedation. BIS values were obtained using standard BIS monitoring immediately before (minute 0) and after the intervention (minute 60). No subscales exist; the BIS value is a single composite index.

Time frame: BIS values will be measured immediately before and after the intervention (minute 0 and 60).

Systolic Blood Pressure

Systolic blood pressure was obtained using standard ICU monitoring before (minute 0) and after (minute 60) the intervention. This measure reflects hemodynamic response to the music intervention or standard care.

Time frame: Blood pressure was measured before (minute 0) and after (minute 60) the intervention. Although values were recorded every 10 minutes, only baseline and final measurements are reported.

Diastolic Blood Pressure

Diastolic blood pressure was obtained using standard ICU monitoring before (minute 0) and after (minute 60) the intervention. This measure reflects autonomic and vascular response to the music intervention or standard care.

Time frame: Blood pressure was measured before (minute 0) and after (minute 60) the intervention. Although values were recorded every 10 minutes, only baseline and final measurements are reported.

Heart Rate

Heart rate was obtained using standard ICU monitoring before (minute 0) and after (minute 60) the intervention. Heart rate reflects autonomic and physiological stress response to the music intervention or standard care.

Time frame: Heart rate was measured before (minute 0) and after (minute 60) the intervention. Although values were recorded every 10 minutes, only baseline and final measurements are reported.

Respiratory Rate

Respiratory rate was obtained using standard ICU respiratory monitoring before (minute 0) and after (minute 60) the intervention. Respiratory rate reflects ventilatory response to the music intervention or standard care.

Time frame: Respiratory rate was measured before (minute 0) and after (minute 60) the intervention. Although values were recorded every 10 minutes, only baseline and final measurements are reported.

Oxygen Saturation

Oxygen saturation (SpO₂) was obtained using standard ICU pulse oximetry before (minute 0) and after (minute 60) the intervention. This measure reflects oxygenation status and respiratory response to the music intervention or standard care.

Time frame: Oxygen saturation was measured before (minute 0) and after (minute 60) the intervention. Although values were recorded every 10 minutes, only baseline and final measurements are reported.

Intracranial Pressure

Intracranial pressure (ICP) was obtained from invasive intraparenchymal or ventricular monitoring devices in patients who had such monitors in place. Measurements were taken at baseline (minute 0) and post-intervention (minute 60). ICP reflects cerebral compliance and intracranial dynamics.

Time frame: Intracranial pressure was measured before (minute 0) and after (minute 60) the intervention in patients with an invasive ICP monitor.

Sedation Medication Use

This outcome includes multiple sedative, analgesic, and neuromuscular-blocking agents used in the ICU. Each drug is reported using its appropriate clinical unit (e.g., mg/kg/h for intravenous medications and ml/h for inhaled anesthetics such as sevoflurane). Mean and standard deviation are presented separately for the music intervention group and the control group at baseline and post-intervention. Each drug appears as an independent row, and units do not mix within rows.

Time frame: Sedative medication infusion rates were measured at baseline (minute 0) and after the intervention (minute 60).

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes