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Effectiveness of Musicotherapy in Weaning From Mechanical Ventilation

NCT04602182 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-12-27

No results posted yet for this study

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.

Conditions

  • Weaning
  • Respiration, Artificial
  • Music Therapy

Interventions

PROCEDURE

music therapy intervention

Patients will receive a daily music therapy intervention from the beginning until the end of the weaning from mechical ventilation.

Sponsors & Collaborators

  • AGRUPARTE S.L.

    collaborator UNKNOWN

  • Basque Health Service

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-19
Primary Completion
2021-10-19
Completion
2022-06-19

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04602182 on ClinicalTrials.gov