Effectiveness of Musicotherapy in Weaning From Mechanical Ventilation

Basque Health Service

Status: Unknown

Conditions: Weaning; Respiration, Artificial; Music Therapy

Treatments: Procedure: music therapy intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04602182

MusicoT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients on mechanical ventilation for at least 48 hours, with the decision to start the process of weaning, which comes determined by the decision to switch from controlled mode to support or spontaneous breathing modalities.

Exclusion criteria

• Patients with established moderate-severe psychiatric pathology.
• Patients with severe hearing deficit.
• Patients in whom the Limitation of Life Support Treatment (LTSV) has been decided and have a life expectancy of less than 48h.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

music therapy gruop (experimental group)

Experimental group

Description:

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

Treatment:

Procedure: music therapy intervention

control group

Active Comparator group

Description:

Control group: Patient will follow the usual clinical practice for the weaning from mecanichal ventilation to the end of the weaning.

Treatment:

Procedure: music therapy intervention