Effectiveness of Musicotherapy in Weaning From Mechanical Ventilation

Status Recruiting

Clinical Trial Summary

1. OBJECTIVES: General objective: Assess the effects of a music therapy intervention during the weaning from the mechanical ventilation in a group of patients, and compare it to the usual clinical practice. Specific objectives: Main objective: assess the effect of a music therapy intervention on the length of the weaning in a group of critical patients, and compare it to a group of critical patients who receive the usual clinical practice. Secondary objectives: - Compare the levels of sedo-analgesia required in critical patients receiving the music therapy intervention during the process of weaning versus the levels of sedo-analgesia required by the control group. - Compare the Anxiety-agitation level in critical patients receiving the music therapy intervention during the process of weaning, versus the anxiety-agitation leved felt by the control group. - Compare the level of pain in critical patients receiving the music therapy intervention during the weaning versus the level of the pain felt by the control group. - Compare the level of delirium in critical patients receiving music therapy during the weaning versus the level of delirium of the control group. - Compare heart and breath frequency, blood pressure and oxygen saturation in critical patients receiving music therapy during the mechanical ventilation extubation (weaning) process, versus the index of control group. - Compare the stress perceived in critical patients receiving music therapy intervention during the mechanical extubation process, versus the level of the control group, which receives the usual medical care (without intervention with music therapy), 90 days after Inico of the process, Perceived the Stress Scale (PSS). - Describe and analyze the experience by the patient of the intervention with music therapy the weaning process and the coping strategies possible for musicotherapeutic intervention, using a Semi-instructed interview that takes place at 90 days beginning the process. 2. DESIGN: single blind clinical trial in parallel groups, single blind clinical trial. 3. POPULATION of this study are patients who initiate weaning for ventilation mechanics.

Clinical Trial Description

Experimental group: Patients will receive a daily music therapy intervention from the beginning until the end of the weaning from mechical ventilation. Control group: Patient will follow the usual clinical practice for the weaning from mecanichal ventilation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04602182
Study type	Interventional
Source	Basque Health Service
Contact
Status	Recruiting
Phase	N/A
Start date	October 19, 2020
Completion date	June 19, 2022

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.