Impact of a standardised music intervention on serum cortisol among sedated, mechanically ventilated adults in the intensive care unit: A randomised controlled trial.

BACKGROUND: Patients receiving invasive mechanical ventilation (IMV) in the intensive care unit (ICU) experience significant physiological stress, which may impair recovery. Music intervention is a promising nonpharmacological strategy to modulate stress responses; however, evidence on its effects on biomarkers such as cortisol remains limited in sedated ICU patients. OBJECTIVE: The aim of this study was to evaluate the effect of a standardised music intervention on serum cortisol levels in critically ill adults undergoing IMV. METHODS: A single-blind randomised controlled trial was conducted in a tertiary public hospital in Spain. Sedated patients (bispectral index: 40-60) on IMV were randomised to either an intervention group (n = 55) receiving a 60-min music session through noise-cancelling headphones or a control group (n = 55) receiving standard care. Serum cortisol was measured immediately before and after the intervention by blinded laboratory personnel. Linear mixed-effect models were used, adjusting for covariates including days of IMV and baseline characteristics. RESULTS: In the intervention group, serum cortisol decreased after the session (mean difference: -1.57 μg/dL; 95% confidence interval [CI]: -2.42 to -0.72), whereas cortisol levels remained stable in the control group (mean difference: -0.14 μg/dL; 95% CI: -0.99 to 0.71). The mixed-effect model demonstrated significant effects of group (F(1,108) = 6.46; p = 0.012), time (F(1,108) = 5.55; p = 0.020), and the group × time interaction (F(1,108) = 7.95; p = 0.006). After adjustment, the intervention remained independently associated with lower postintervention cortisol levels (β = -1.67; 95% CI: -2.90 to -0.44). Each additional IMV day was associated with higher cortisol levels (β = 0.65; 95% CI: 0.24 to 1.06). No significant changes were observed in physiological parameters, indicating haemodynamic and neurological stability. CONCLUSIONS: A standardised music intervention significantly reduced serum cortisol levels in sedated, mechanically ventilated ICU patients without affecting physiological stability. These findings support music as a safe, nonpharmacological adjunct to modulate stress responses in critical care.