NCT06120660

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

Effects of a Musical Intervention on Hormonal and Inflammatory Biomarkers in Mechanically Ventilated Critically Ill Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: University of Oviedo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Music Therapy	A 60-minute session of relaxing, slow-tempo recorded music (60-80 bpm) delivered through over-ear headphones. The intervention is administered once, while the patient remains sedated and mechanically ventilated. Volume and audio equipment are adjusted according to ICU safety protocols.

Timeline

• Start date: 2023-10-14
• Primary completion: 2025-06-28
• Completion: 2026-01-27
• First posted: 2023-11-07
• Last updated: 2026-03-25
• Results posted: 2026-03-25

Locations

1 site across 1 country: Spain