Effectiveness of Musicotherapy in Weaning From Mechanical Ventilation

NCT04602182 | Unknown

• 1 other identifier: MusicoT
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

• 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.
• DESIGN: single blind clinical trial in parallel groups, single blind clinical trial.
• POPULATION of this study are patients who initiate weaning for ventilation mechanics.

Conditions

Weaning; Respiration, Artificial; Music Therapy

Outcome Measures

Primary Outcomes (1)

• Lenght of weaning from mechanical ventilation (hours)

  Time in hours from the beginning to the end of the disconnection process

  within 1 week

Secondary Outcomes (10)

• Sedoanalgesia average dosis

  within 1 week (during the weaning)

• Score on the Richmond Agitation scale-24 hours prior to the start of the study, and every eight hours during the study and at the end of the mechanic ventilation disconnection period

  within 1 week (during the weaning)

• Score on the Confusion Assessment Method scale for Intensive Care Units (CAM-ICU) 24 hours prior to the start of the study, and every eight hours during the study and at the end of the mechanical ventilation disconnection period

  within 1 week (during the weaning)

• Systolic TA (mm hg) at the beginning, at the end of the intervention, and 30 minutes after the end

  within 1 week (during the weaning)

• Diastolic TA (mm hg) at the beginning, at the end of the operation, and 30 minutes after the end

  within 1 week (during the weaning)

Study Arms (2)

music therapy gruop (experimental group)

EXPERIMENTAL

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

Procedure: music therapy intervention

control group

ACTIVE COMPARATOR

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

Procedure: music therapy intervention

Interventions

music therapy intervention PROCEDURE

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

control group; music therapy gruop (experimental group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Basque Health Service: lead
• AGRUPARTE S.L.: collaborator

Study Sites (2)

Araba university hospital

Vitoria-Gasteiz, Alava, Spain

RECRUITING

Esther Corral

Vitoria-Gasteiz, Alava, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The person responsable for carrying out the statistical analysis will be blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: intensive medicine physician

Model Details: Single-blind randomized clinical trial in parallel groups and controlled with standard clinical practice.

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 26, 2020
• Study Start: October 19, 2020
• Primary Completion: October 19, 2021
• Study Completion: June 19, 2022
• Last Updated: December 27, 2021

Record last verified: 2021-12

Locations

ES (2)