Effectiveness of Musicotherapy in Weaning From Mechanical Ventilation

NCT ID: NCT04602182

Last Updated: 2021-12-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-19
• Study Completion Date: 2022-06-19

Brief 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.

Detailed 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.

Conditions

Weaning; Respiration, Artificial; Music Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

music therapy gruop (experimental group)

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

Group Type: EXPERIMENTAL

music therapy intervention

Intervention Type: PROCEDURE

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

control group

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

Group Type: ACTIVE_COMPARATOR

music therapy intervention

Intervention Type: PROCEDURE

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

Interventions

music therapy intervention

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AGRUPARTE S.L.

UNKNOWN

Sponsor Role: collaborator

Basque Health Service

OTHER_GOV

Sponsor Role: lead

Responsible Party

Esther Corral Lozano

intensive medicine physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Araba university hospital

Vitoria-Gasteiz, Alava, Spain

Site Status: RECRUITING

Esther Corral

Vitoria-Gasteiz, Alava, Spain

Site Status: NOT_YET_RECRUITING

Countries

Spain

Facility Contacts

ESTHER CORRAL

Role: primary

ESTHER CORRAL

Role: primary

Other Identifiers

MusicoT

Identifier Type: -

Identifier Source: org_study_id