NCT04291677

Music in Vein in the Intensive Care Unit

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Juan Carlos Montejo González · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mechanical Ventilation

Interventions

Type	Name	Description
OTHER	intervention musical	Intervention group in which musical intervention will be applied the first or third day of mechanical ventilation.
OTHER	Without intervention musical	Control group with standard treatment without musical intervention.

Timeline

• Start date: 2017-01-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2020-03-02
• Last updated: 2021-02-10

Locations

1 site across 1 country: Spain