Mechanical VentilationNCT04291677
Music in Vein in the Intensive Care Unit
A study testing intervention musical and Without intervention musical in people with Mechanical Ventilation, run by Juan Carlos Montejo González at 1 site in Spain.
Trial summary
Patients admitted to the Intensive Care Units (ICU) that receive mechanical ventilation need high dose sedative and analgesic medication that may have side effects. Despite this, many of them also experience anxiety and added stress. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- intervention musical and Without intervention musical
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2017to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients admitted to the ICU with requirements for mechanical ventilation and in which the unit's pseudoanalgesia protocol is implemented.
- A legal representative informed consent to participate in the study has to be signed.
Who cannot join
- Patients admitted to the ICU with predictable survival less than 48 hours.
- Patients who are not subjected to mechanical ventilation.
- Patients whose Legal representative refuses to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Patients admitted to the Intensive Care Units (ICU) that receive mechanical ventilation need high dose sedative and analgesic medication that may have side effects. Despite this, many of them also experience anxiety and added stress.
Musical intervention is a useful non-pharmacological tool without adverse effects safe and easy to provide for patients with mechanical ventilation admitted to the Intensive Care Units. Its use reduces the use and dose of sedatives, reduces stress and environmental noise. It should be considered in the measures of control of anxiety and noise in the ICU.
The objective of the study is to analyze whether the implementation of a musical intervention can be an effective non-pharmacological intervention in the therapy of patients undergoing mechanical ventilation admitted to an Intensive Care Unit of a High Complexity Hospital.
Read the detailed description
This is a prospective, randomized clinical study will be developed in the three Units of Intensive Care of the Intensive Medicine Service of the 12 de Octubre Universitarian Hospital. All adult patients admitted to the ICU with requirements for mechanical ventilation and in which the unit's pseudoanalgesia protocol is implemented and having signed your legal representative informed consent to participate in the study will be included. The Patients admitted to the ICU with predictable survival less than 48 hours; those who are not submitted to mechanical ventilation and those whose Legal representative refuses to sign the informed consent wouldn't participate.
The patients will be randomized in two groups: Group A: Intervention group in which musical intervention will be applied between the first and the third day of mechanical ventilation. Group B: Control group with standard treatment without musical intervention.
Live music will be applied every day of the week by professional musicians of the non-profit association Music in Vena (MeV) until mechanical ventilation is removed. There will be sessions of 30 minutes a day. The execution time will be from 13-13:30 hours, and the family will be allowed to participate. The type of music will be classical to be determined by musicians.
The participants will be followed for the duration invasive mechanical ventilation.
The Investigators of this project ensure that the principalities ethics for medical research in beings humans of the HELSINKI DECLARATION OF THE WORLD MEDICAL ASSOCIATION have been adapted. MUSICALCARE-ICU has been approved by the Ethics Committee of the 12 de Octubre Universitarian Hospital. The legal representative must give written informed consent to participate in this study.
- Conditions
- Mechanical Ventilation
- Being tested
- intervention musical, Without intervention musical
- Keywords
- Critical patient, Intensive care unit, Mechanical ventilation, Sedative and analgesic medication, Anxiety, Live musical intervention
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervention musicalOther
Intervention group in which musical intervention will be applied the first or third day of mechanical ventilation.
Without intervention musicalOther
Control group with standard treatment without musical intervention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group in which musical intervention | Experimental | Group A: Experimental group in which musical intervention will be applied between the first and the third day of mechanical ventilation. Receives: Other: intervention musical |
| Control group | Other | Group B: Control group with standard treatment without musical intervention. Receives: Other: Without intervention musical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total and extra pseudoanalgesia requirements change.
Change of the anxiety and pain level in patients with invasive mechanical ventilation with music therapy.
Measured: It will be analyzed at baseline, at the end of the musical intervention, at 30 minutes, 60 minutes and at 8 hours after the intervention.
Secondary outcomes (9)
Change of Heart rate.
Change of the heart rate registered in electrocardiogram in patients with invasive mechanical ventilation with music therapy.
Measured: It will be analyzed at baseline, at the end of the musical intervention, at 30 minutes, 60 minutes and at 8 hours after the intervention.
Change of systolic blood pressure; diastolic blood pressure and mean blood pressure.
Change systolic blood pressure; diastolic blood pressure and average blood pressure.
Measured: It will be analyzed at baseline, at the end of the musical intervention, at 30 minutes, 60 minutes and at 8 hours after the intervention.
Change vasoactive drug requirements.
Percentage of patients who experience a change of the vasoactive drug requirements in patients with invasive mechanical ventilation with music therapy.
Measured: It will be analyzed at baseline, at the end of the musical intervention, at 30 minutes, 60 minutes and at 8 hours after the intervention.
Blood glucose control.
Percentage of patients who normalize blood glucose levels (range 70-110 milligrams/deciliter).
Measured: It will be analyzed at baseline, at the end of the musical intervention, at 30 minutes, 60 minutes and at 8 hours after the intervention.
Change insulin requirements.
Percentage of patients who change insulin requirements measured as International Unit per day (IU/day).
Measured: It will be analyzed at baseline, at the end of the musical intervention, at 30 minutes, 60 minutes and at 8 hours after the intervention.
Change cortisol and growth hormone level.
Change serum levels biomarkers (cortisol and growth hormone level) in patients with invasive mechanical ventilation with music therapy.
Measured: It will be performed at 9 hours, prior to the implementation of the musical intervention, and at 30 minutes after the end of the intervention on days 1, 3, 7 and 10.
Change the stay in the Intensive Care Unit (ICU)
Change in mechanical ventilation time in patients with musical intervention reduces ICU stay.
Measured: At 90 days
Quality of Life (HRQoL) according to Karnofsky's index.
Change in the Quality of Life (QoL) will be measured using the Karnofsky Performance Status other method to assess the functional status of a patient. The Karnofsky index, between 100 and 0.
100-Normal, no complaints; no evidence of disease. 90-Able to carry on normal activity; minor signs or symptoms of disease. 80-Normal activity with effort, some signs or symptoms of disease. 70-Cares for self but unable to carry on normal activity or to do active work. 60-Requires occasional assistance but is able to care for most of personal needs.
50-Requires considerable assistance and frequent medical care. 40-Disabled; requires special care and assistance. 30-Severely disabled; hospitalization is indicated although death not imminent. 20-Very ill; hospitalization and active supportive care necessary. 10-Moribund 0-Dead
Measured: At 90 days
The overall Health related Quality of Life (HRQoL) of patients with requirements for mechanical ventilation will be measured using a patient self rating questionnaire.
Change in the Quality of Life (QoL) will be measured using the Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status who describes a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.).
Grade 0: Fully active, able to carry on all pre-disease performance without restriction.
Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
Grade 2: Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours.
Grade 3: Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours Grade 4: Completely disabled; cannot carry on any selfcare; totally confined to bed or chair Grade 5: Dead.
Measured: At 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study startJan 2017
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juan Carlos Montejo González
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan Carlos Montejo González, Hospital Universitario 12 de Octubre
- Investigators
- Juan Carlos Montejo, PhD MD, Study chair, Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291677
- Sponsor's protocol ID
- MUSICALCARE-ICU
- Status last verified
- Feb 2021
- First submitted
- 19 Feb 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music in Vein in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04291677
- Acronym / sponsor ID
- MUSICALCARE-ICU
- Conditions
- Mechanical Ventilation
- Keywords
- Critical patient, Intensive care unit, Mechanical ventilation, Sedative and analgesic medication, Anxiety, Live musical intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Juan Carlos Montejo GonzálezUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients admitted to the Intensive Care Units (ICU) that receive mechanical ventilation need high dose sedative and analgesic medication that may have side effects. Despite this, many of them also experience anxiety and added stress.
Musical intervention is a useful non-pharmacological tool without adverse effects safe and easy to provide for patients with mechanical ventilation admitted to the Intensive Care Units. Its use reduces the use and dose of sedatives, reduces stress and environmental noise. It should be considered in the measures of control of anxiety and noise in the ICU.
The objective of the study is to analyze whether the implementation of a musical intervention can be an effective non-pharmacological intervention in the therapy of patients undergoing mechanical ventilation admitted to an Intensive Care Unit of a High Complexity Hospital.
Detailed description
This is a prospective, randomized clinical study will be developed in the three Units of Intensive Care of the Intensive Medicine Service of the 12 de Octubre Universitarian Hospital. All adult patients admitted to the ICU with requirements for mechanical ventilation and in which the unit's pseudoanalgesia protocol is implemented and having signed your legal representative informed consent to participate in the study will be included. The Patients admitted to the ICU with predictable survival less than 48 hours; those who are not submitted to mechanical ventilation and those whose Legal representative refuses to sign the informed consent wouldn't participate.
The patients will be randomized in two groups: Group A: Intervention group in which musical intervention will be applied between the first and the third day of mechanical ventilation. Group B: Control group with standard treatment without musical intervention.
Live music will be applied every day of the week by professional musicians of the non-profit association Music in Vena (MeV) until mechanical ventilation is removed. There will be sessions of 30 minutes a day. The execution time will be from 13-13:30 hours, and the family will be allowed to participate. The type of music will be classical to be determined by musicians.
The participants will be followed for the duration invasive mechanical ventilation.
The Investigators of this project ensure that the principalities ethics for medical research in beings humans of the HELSINKI DECLARATION OF THE WORLD MEDICAL ASSOCIATION have been adapted. MUSICALCARE-ICU has been approved by the Ethics Committee of the 12 de Octubre Universitarian Hospital. The legal representative must give written informed consent to participate in this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group in which musical intervention | Experimental | Other: intervention musicalGroup A: Experimental group in which musical intervention will be applied between the first and the third day of mechanical ventilation. |
| Control group | Other | Other: Without intervention musicalGroup B: Control group with standard treatment without musical intervention. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients admitted to the ICU with requirements for mechanical ventilation and in which the unit's pseudoanalgesia protocol is implemented.
- A legal representative informed consent to participate in the study has to be signed.
Key exclusion criteria (3 listed)
- Patients admitted to the ICU with predictable survival less than 48 hours.
- Patients who are not subjected to mechanical ventilation.
- Patients whose Legal representative refuses to sign the informed consent.
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 |
|---|---|---|
| intervention musicalIntervention group in which musical intervention will be applied the first or third day of mechanical ventilation. | Other | Intervention group in which musical intervention |
| Without intervention musicalControl group with standard treatment without musical intervention. | Other | Control group |
Primary outcome
Total and extra pseudoanalgesia requirements change.
Time frame: It will be analyzed at baseline, at the end of the musical intervention, at 30 minutes, 60 minutes and at 8 hours after the intervention.
Change of the anxiety and pain level in patients with invasive mechanical ventilation with music therapy.
9 secondary outcomes
Change of Heart rate.
Time frame: It will be analyzed at baseline, at the end of the musical intervention, at 30 minutes, 60 minutes and at 8 hours after the intervention.
Change of systolic blood pressure; diastolic blood pressure and mean blood pressure.
Time frame: It will be analyzed at baseline, at the end of the musical intervention, at 30 minutes, 60 minutes and at 8 hours after the intervention.
Change vasoactive drug requirements.
Time frame: It will be analyzed at baseline, at the end of the musical intervention, at 30 minutes, 60 minutes and at 8 hours after the intervention.
Blood glucose control.
Time frame: It will be analyzed at baseline, at the end of the musical intervention, at 30 minutes, 60 minutes and at 8 hours after the intervention.
Change insulin requirements.
Time frame: It will be analyzed at baseline, at the end of the musical intervention, at 30 minutes, 60 minutes and at 8 hours after the intervention.
Change cortisol and growth hormone level.
Time frame: It will be performed at 9 hours, prior to the implementation of the musical intervention, and at 30 minutes after the end of the intervention on days 1, 3, 7 and 10.
Change the stay in the Intensive Care Unit (ICU)
Time frame: At 90 days
Quality of Life (HRQoL) according to Karnofsky's index.
Time frame: At 90 days
The overall Health related Quality of Life (HRQoL) of patients with requirements for mechanical ventilation will be measured using a patient self rating questionnaire.
Time frame: At 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Juan Carlos Montejo, PhD MD study chair
Hospital Universitario 12 de Octubre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intervention musical and Without intervention musical in people with Mechanical Ventilation, run by Juan Carlos Montejo González 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 3 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: status not confirmed, as of the sponsor's last update on 10 Feb 2021. 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?
Results are not available in the source record.
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?
Total and extra pseudoanalgesia requirements change. (time frame: It will be analyzed at baseline, at the end of the musical intervention, at 30 minutes, 60 minutes and at 8 hours after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2021.