Clinical trial NCT04291677: Music in Vein in the Intensive Care Unit
Official title: Music in Vein in the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mechanical Ventilation
Keywords: Critical patient
Intensive care unit
Mechanical ventilation
Sedative and analgesic medication
Anxiety
Live musical intervention
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Total and extra pseudoanalgesia requirements change.
timeFrame: 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:
measure: Change of Heart rate.
timeFrame: 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.
measure: Change of systolic blood pressure; diastolic blood pressure and mean blood pressure.
timeFrame: 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.
measure: Change vasoactive drug requirements.
timeFrame: 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.
measure: Blood glucose control.
timeFrame: 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.
measure: Change insulin requirements.
timeFrame: 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.
measure: Change cortisol and growth hormone level.
timeFrame: 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.
measure: Change the stay in the Intensive Care Unit (ICU)
timeFrame: At 90 days
measure: Quality of Life (HRQoL) according to Karnofsky's index.
timeFrame: At 90 days
measure: The overall Health related Quality of Life (HRQoL) of patients with requirements for mechanical ventilation will be measured using a patient self rating questionnaire.
timeFrame: At 90 days
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
affiliation: Hospital Universitario 12 de Octubre
name: Juan Carlos Montejo, PhD MD
role: STUDY_CHAIR
References: