SedationNCT06120660

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

A study testing Music Therapy in people with Sedation and Critical Illness, run by University of Oviedo at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Sedation, Critical Illness, Respiration, Artificial
What is being tested?: Music Therapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 1 siteSpain
Study dates: 14 Oct 2023to 27 Jan 2026
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011

Other trials in Spain

About this study

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

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

Read the 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
Being tested: Music Therapy
Keywords: music therapy, critical care, stress, psychological, respiration, artificial, sedation, inflammation
Medical subject headings: Critical Illness, Respiratory Aspiration, Inflammation, Stress, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Music TherapyOther
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.

Study groups in NCT06120660
Study group	Role	What they receive
Music Intervention	Experimental	Participants assigned to this arm receive a structured music therapy session delivered through headphones in addition to usual ICU care. Receives: Other: Music Therapy
Standard Care (Control)	No intervention	Participants assigned to this arm receive usual ICU care without any additional auditory intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

Levels of Serum Cortisol
Serum cortisol levels were measured from venous blood samples collected immediately before (minute 0) and after (minute 60) the music intervention or standard care using standard laboratory assays. This measure reflects the acute physiological stress response.
Measured: Only one intervention per person will be performed. Serum levels will be measured before and after the intervention (minute 0 and 60).
Levels of Prolactin
Serum prolactin levels were measured from venous blood samples obtained immediately before (minute 0) and after (minute 60) the intervention using standard laboratory immunoassays. This biomarker reflects neuroendocrine stress response and can indicate changes related to the music intervention.
Measured: 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.
Levels of Interleukin 6
Serum interleukin-6 (IL-6) levels were measured from venous blood samples collected immediately before (minute 0) and after (minute 60) the intervention using standard laboratory immunoassays. IL-6 is a pro-inflammatory cytokine and its serum concentration reflects acute systemic inflammatory activity.
Measured: 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.

Secondary outcomes (8)

Bispectral Index (BIS)
The Bispectral Index (BIS) is a processed electroencephalographic scale used to quantify the depth of sedation or anesthesia. BIS values range from 0 to 100, where 100 represents a fully awake state and 0 represents EEG silence. Lower scores indicate deeper sedation, while higher scores indicate lighter sedation. BIS values were obtained using standard BIS monitoring immediately before (minute 0) and after the intervention (minute 60). No subscales exist; the BIS value is a single composite index.
Measured: BIS values will be measured immediately before and after the intervention (minute 0 and 60).
Systolic Blood Pressure
Systolic blood pressure was obtained using standard ICU monitoring before (minute 0) and after (minute 60) the intervention. This measure reflects hemodynamic response to the music intervention or standard care.
Measured: Blood pressure was measured before (minute 0) and after (minute 60) the intervention. Although values were recorded every 10 minutes, only baseline and final measurements are reported.
Diastolic Blood Pressure
Diastolic blood pressure was obtained using standard ICU monitoring before (minute 0) and after (minute 60) the intervention. This measure reflects autonomic and vascular response to the music intervention or standard care.
Measured: Blood pressure was measured before (minute 0) and after (minute 60) the intervention. Although values were recorded every 10 minutes, only baseline and final measurements are reported.
Heart Rate
Heart rate was obtained using standard ICU monitoring before (minute 0) and after (minute 60) the intervention. Heart rate reflects autonomic and physiological stress response to the music intervention or standard care.
Measured: Heart rate was measured before (minute 0) and after (minute 60) the intervention. Although values were recorded every 10 minutes, only baseline and final measurements are reported.
Respiratory Rate
Respiratory rate was obtained using standard ICU respiratory monitoring before (minute 0) and after (minute 60) the intervention. Respiratory rate reflects ventilatory response to the music intervention or standard care.
Measured: Respiratory rate was measured before (minute 0) and after (minute 60) the intervention. Although values were recorded every 10 minutes, only baseline and final measurements are reported.
Oxygen Saturation
Oxygen saturation (SpO₂) was obtained using standard ICU pulse oximetry before (minute 0) and after (minute 60) the intervention. This measure reflects oxygenation status and respiratory response to the music intervention or standard care.
Measured: Oxygen saturation was measured before (minute 0) and after (minute 60) the intervention. Although values were recorded every 10 minutes, only baseline and final measurements are reported.
Intracranial Pressure
Intracranial pressure (ICP) was obtained from invasive intraparenchymal or ventricular monitoring devices in patients who had such monitors in place. Measurements were taken at baseline (minute 0) and post-intervention (minute 60). ICP reflects cerebral compliance and intracranial dynamics.
Measured: Intracranial pressure was measured before (minute 0) and after (minute 60) the intervention in patients with an invasive ICP monitor.
Sedation Medication Use
This outcome includes multiple sedative, analgesic, and neuromuscular-blocking agents used in the ICU. Each drug is reported using its appropriate clinical unit (e.g., mg/kg/h for intravenous medications and ml/h for inhaled anesthetics such as sevoflurane).
Mean and standard deviation are presented separately for the music intervention group and the control group at baseline and post-intervention. Each drug appears as an independent row, and units do not mix within rows.
Measured: Sedative medication infusion rates were measured at baseline (minute 0) and after the intervention (minute 60).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Oct 202327 Jan 2026

First posted7 Nov 2023
Study start14 Oct 2023
Primary completion28 Jun 2025
Study completion27 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for SedationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Two-arm parallel design comparing a musical intervention plus usual care versus usual care alone in mechanically ventilated ICU patients.
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06120660
Sponsor's protocol ID: 2022.537
Other IDs: Investiga SEEIUC 2023
Status last verified: Mar 2026
First submitted: 14 Oct 2023
Last updated: 25 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: IPD will not be shared because the dataset contains sensitive clinical and biological information from critically ill patients that cannot be completely de-identified.

Publications

Erdogan Z, Atik D. Complementary Health Approaches Used in the Intensive Care Unit. Holist Nurs Pract. 2017 Sep/Oct;31(5):325-342. doi: 10.1097/HNP.0000000000000227.
PubMed 28786890
Umbrello M, Sorrenti T, Mistraletti G, Formenti P, Chiumello D, Terzoni S. Music therapy reduces stress and anxiety in critically ill patients: a systematic review of randomized clinical trials. Minerva Anestesiol. 2019 Aug;85(8):886-898. doi: 10.23736/S0375-9393.19.13526-2. Epub 2019 Apr 3.
PubMed 30947484
Thaut MH. Music as therapy in early history. Prog Brain Res. 2015;217:143-58. doi: 10.1016/bs.pbr.2014.11.025. Epub 2015 Jan 31.
PubMed 25725914
Seyffert S, Moiz S, Coghlan M, Balozian P, Nasser J, Rached EA, Jamil Y, Naqvi K, Rawlings L, Perkins AJ, Gao S, Hunter JD 3rd, Khan S, Heiderscheit A, Chlan LL, Khan B. Decreasing delirium through music listening (DDM) in critically ill, mechanically ventilated older adults in the intensive care unit: a two-arm, parallel-group, randomized clinical trial. Trials. 2022 Jul 19;23(1):576. doi: 10.1186/s13063-022-06448-w.
PubMed 35854358
Kakar E, Billar RJ, van Rosmalen J, Klimek M, Takkenberg JJM, Jeekel J. Music intervention to relieve anxiety and pain in adults undergoing cardiac surgery: a systematic review and meta-analysis. Open Heart. 2021 Jan;8(1):e001474. doi: 10.1136/openhrt-2020-001474.
PubMed 33495383
Khan SH, Wang S, Harrawood A, Martinez S, Heiderscheit A, Chlan L, Perkins AJ, Tu W, Boustani M, Khan B. Decreasing Delirium through Music (DDM) in critically ill, mechanically ventilated patients in the intensive care unit: study protocol for a pilot randomized controlled trial. Trials. 2017 Nov 29;18(1):574. doi: 10.1186/s13063-017-2324-6.
PubMed 29187230
Khan SH, Kitsis M, Golovyan D, Wang S, Chlan LL, Boustani M, Khan BA. Effects of music intervention on inflammatory markers in critically ill and post-operative patients: A systematic review of the literature. Heart Lung. 2018 Sep-Oct;47(5):489-496. doi: 10.1016/j.hrtlng.2018.05.015. Epub 2018 Jul 9.
PubMed 30001799
Taets GGC, Jomar RT, Abreu AMM, Capella MAM. Effect of music therapy on stress in chemically dependent people: a quasi-experimental study. Rev Lat Am Enfermagem. 2019 Jan 17;27:e3115. doi: 10.1590/1518-8345.2456.3115.
PubMed 30698217

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sedation trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of a Musical Intervention on Hormonal and Inflammatory Biomarkers in Mechanically Ventilated Critically Ill Patients
ClinicalTrials.gov ID: NCT06120660
Acronym / sponsor ID: 2022.537
Conditions: Sedation, Critical Illness, Respiration, Artificial, Inflammation, Stress, Physiological
Keywords: music therapy, critical care, stress, psychological, respiration, artificial, sedation, inflammation
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: University of OviedoUniversity, hospital or other
Collaborators: Sociedad Española de Enfermería Intensiva y Unidades Coronarias
Study start: 14 Oct 2023 (actual)
Primary completion: 28 Jun 2025 (actual)
Study completion: 27 Jan 2026 (actual)
First posted: 7 Nov 2023 (actual)
Results: Posted 25 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Participants:

Interventions:

Outcomes and Variables:

Data Collection and Analysis:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2
Model description: Two-arm parallel design comparing a musical intervention plus usual care versus usual care alone in mechanically ventilated ICU patients.

Arm	Type	Receives
Music Intervention	Experimental	Other: Music TherapyParticipants assigned to this arm receive a structured music therapy session delivered through headphones in addition to usual ICU care.
Standard Care (Control)	No intervention	–Participants assigned to this arm receive usual ICU care without any additional auditory intervention.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Music TherapyA 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.	Other	Music Intervention

Primary outcome

Levels of Serum Cortisol
Time frame: Only one intervention per person will be performed. Serum levels will be measured before and after the intervention (minute 0 and 60).
Serum cortisol levels were measured from venous blood samples collected immediately before (minute 0) and after (minute 60) the music intervention or standard care using standard laboratory assays. This measure reflects the acute physiological stress response.
Levels of Prolactin
Time frame: 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.
Serum prolactin levels were measured from venous blood samples obtained immediately before (minute 0) and after (minute 60) the intervention using standard laboratory immunoassays. This biomarker reflects neuroendocrine stress response and can indicate changes related to the music intervention.
Levels of Interleukin 6
Time frame: 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.
Serum interleukin-6 (IL-6) levels were measured from venous blood samples collected immediately before (minute 0) and after (minute 60) the intervention using standard laboratory immunoassays. IL-6 is a pro-inflammatory cytokine and its serum concentration reflects acute systemic inflammatory activity.

8 secondary outcomes

Bispectral Index (BIS)
Time frame: BIS values will be measured immediately before and after the intervention (minute 0 and 60).
Systolic Blood Pressure
Time frame: Blood pressure was measured before (minute 0) and after (minute 60) the intervention. Although values were recorded every 10 minutes, only baseline and final measurements are reported.
Diastolic Blood Pressure
Time frame: Blood pressure was measured before (minute 0) and after (minute 60) the intervention. Although values were recorded every 10 minutes, only baseline and final measurements are reported.
Heart Rate
Time frame: Heart rate was measured before (minute 0) and after (minute 60) the intervention. Although values were recorded every 10 minutes, only baseline and final measurements are reported.
Respiratory Rate
Time frame: Respiratory rate was measured before (minute 0) and after (minute 60) the intervention. Although values were recorded every 10 minutes, only baseline and final measurements are reported.
Oxygen Saturation
Time frame: Oxygen saturation was measured before (minute 0) and after (minute 60) the intervention. Although values were recorded every 10 minutes, only baseline and final measurements are reported.
Intracranial Pressure
Time frame: Intracranial pressure was measured before (minute 0) and after (minute 60) the intervention in patients with an invasive ICP monitor.
Sedation Medication Use
Time frame: Sedative medication infusion rates were measured at baseline (minute 0) and after the intervention (minute 60).

Results and safety

Results posted to the registry on 25 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Music Intervention	55	55
Standard Care (Control)	55	55

Primary outcome: Levels of Serum Cortisol

Time frame: Only one intervention per person will be performed. Serum levels will be measured before and after the intervention (minute 0 and 60).. Mean (Standard Deviation). Unit: µg/dL

Measure	Music Intervention n = 55	Standard Care (Control) n = 55
Baseline (minute 0)	13.13 (8.47)	15.93 (7.76)
Post-intervention (minute 60)	11.56 (7.69)	16.07 (6.79)

Population analysed: All enrolled participants were included in the analysis for serum cortisol. No participants were excluded.

Primary outcome: Levels of Prolactin

Time frame: 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.. Mean (Standard Deviation). Unit: ng/mL

Measure	Music Intervention n = 55	Standard Care (Control) n = 55
Baseline (minute 0)	46.18 (72.70)	45.74 (60.31)
Post-intervention (minute 60)	45.20 (73.88)	46.36 (61.26)

Population analysed: All enrolled participants were included in the analysis for serum prolactin. No participants were excluded.

Primary outcome: Levels of Interleukin 6

Time frame: 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.. Mean (Standard Deviation). Unit: pg/mL

Measure	Music Intervention n = 55	Standard Care (Control) n = 55
Baseline (minute 0)	148.76 (229.16)	110.60 (105.20)
Post-intervention (minute 60)	150.30 (223.99)	111.66 (104.65)

Population analysed: All enrolled participants were included in the analysis for serum interleukin-6. No participants were excluded.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were monitored from the start of the intervention until the end of the 60-minute follow-up period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Music Intervention	0 of 55 (0%)	0 of 55 (0%)	0 of 55
Standard Care (Control)	0 of 55 (0%)	0 of 55 (0%)	0 of 55

Limitations and caveats (from the sponsor): This single-center study was conducted in the complex ICU environment, where multiple confounders may influence physiological responses. The inclusion of sedated patients and the use of a single standardized music piece limit generalizability to other populations and personalized music approaches.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28786890Erdogan Z, Atik D. Complementary Health Approaches Used in the Intensive Care Unit. Holist Nurs Pract. 2017 Sep/Oct;31(5):325-342. doi: 10.1097/HNP.0000000000000227.
Background: PubMed 30947484Umbrello M, Sorrenti T, Mistraletti G, Formenti P, Chiumello D, Terzoni S. Music therapy reduces stress and anxiety in critically ill patients: a systematic review of randomized clinical trials. Minerva Anestesiol. 2019 Aug;85(8):886-898. doi: 10.23736/S0375-9393.19.13526-2. Epub 2019 Apr 3.
Background: PubMed 25725914Thaut MH. Music as therapy in early history. Prog Brain Res. 2015;217:143-58. doi: 10.1016/bs.pbr.2014.11.025. Epub 2015 Jan 31.
Background: PubMed 35854358Seyffert S, Moiz S, Coghlan M, Balozian P, Nasser J, Rached EA, Jamil Y, Naqvi K, Rawlings L, Perkins AJ, Gao S, Hunter JD 3rd, Khan S, Heiderscheit A, Chlan LL, Khan B. Decreasing delirium through music listening (DDM) in critically ill, mechanically ventilated older adults in the intensive care unit: a two-arm, parallel-group, randomized clinical trial. Trials. 2022 Jul 19;23(1):576. doi: 10.1186/s13063-022-06448-w.
Background: PubMed 33495383Kakar E, Billar RJ, van Rosmalen J, Klimek M, Takkenberg JJM, Jeekel J. Music intervention to relieve anxiety and pain in adults undergoing cardiac surgery: a systematic review and meta-analysis. Open Heart. 2021 Jan;8(1):e001474. doi: 10.1136/openhrt-2020-001474.
Background: PubMed 29187230Khan SH, Wang S, Harrawood A, Martinez S, Heiderscheit A, Chlan L, Perkins AJ, Tu W, Boustani M, Khan B. Decreasing Delirium through Music (DDM) in critically ill, mechanically ventilated patients in the intensive care unit: study protocol for a pilot randomized controlled trial. Trials. 2017 Nov 29;18(1):574. doi: 10.1186/s13063-017-2324-6.
Background: PubMed 30001799Khan SH, Kitsis M, Golovyan D, Wang S, Chlan LL, Boustani M, Khan BA. Effects of music intervention on inflammatory markers in critically ill and post-operative patients: A systematic review of the literature. Heart Lung. 2018 Sep-Oct;47(5):489-496. doi: 10.1016/j.hrtlng.2018.05.015. Epub 2018 Jul 9.
Background: PubMed 30698217Taets GGC, Jomar RT, Abreu AMM, Capella MAM. Effect of music therapy on stress in chemically dependent people: a quasi-experimental study. Rev Lat Am Enfermagem. 2019 Jan 17;27:e3115. doi: 10.1590/1518-8345.2456.3115.
Individual participant dataSharing planned: No. IPD will not be shared because the dataset contains sensitive clinical and biological information from critically ill patients that cannot be completely de-identified.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alba Maestro-González, Ph.D. principal investigator

University of Oviedo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Music Therapy in people with Sedation and Critical Illness, run by University of Oviedo at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Levels of Serum Cortisol (time frame: Only one intervention per person will be performed. Serum levels will be measured before and after the intervention (minute 0 and 60).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06120660, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.