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Soothing sounds may soothe ICU stress: music therapy tested on ventilated patients

NCT ID NCT06120660

Symptom relief Sponsor: University of Oviedo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a single 60-minute session of relaxing music (60-80 bpm) played through headphones could reduce stress and inflammation in 110 sedated adults on breathing machines in the ICU. Researchers measured stress hormones and inflammatory markers in blood before and after the music. The goal was to see if music can help calm the body's stress response in critically ill patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
relaxing recorded music (60-80 bpm) delivered through headphones
What this could lead to
If it works, this could point toward a simple, drug-free way to lower stress and inflammation in critically ill patients on breathing machines.
What could go wrong
This is a small, single-session study with 110 patients. The music was played only once, so long-term effects are unknown. Results may not apply to all ICU patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

110 people

The number who actually took part.

Started

Oct 2023

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Critical Illness Inflammation inflammatory disease Respiratory Aspiration Stress, Psychological

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Critical illness Inflammation Respiration, artificial Sedation Stress, physiological

Contacts and locations

Locations

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011, Spain

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