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

NCT06120660 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-03-25

Study results available
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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

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Sociedad Española de Enfermería Intensiva y Unidades Coronarias

    collaborator UNKNOWN

  • University of Oviedo

    lead OTHER

Principal Investigators

  • Alba Maestro-González, Ph.D. · University of Oviedo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-14
Primary Completion
2025-06-28
Completion
2026-01-27

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06120660 on ClinicalTrials.gov