Musical Intervention and Physiological Stress and Inflammatory Biomarkers in Mechanically Ventila… (NCT06120660) | Clinical Trial Compass
CompletedNot Applicable
Musical Intervention and Physiological Stress and Inflammatory Biomarkers in Mechanically Ventilated ICU Patients
Spain110 participantsStarted 2023-10-14
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Levels of Serum Cortisol
Timeframe: Only one intervention per person will be performed. Serum levels will be measured before and after the intervention (minute 0 and 60).
2
Levels of Prolactin
Timeframe: 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.
3
Levels of Interleukin 6
Timeframe: 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.