Clinical trial NCT04602182: Effectiveness of Musicotherapy in Weaning From Mechanical Ventilation
Official title: EFFECTS OF AN INTERVENTION WITH MUSICOTHERAPY IN THE WEANING FROM MECHANICAL VENTILATION IN PATIENTS OF THE INTENSIVE MEDICINE UNIT OF THE ALAVA UNIVERSITY HOSPITAL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Weaning
Respiration, Artificial
Music Therapy
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
Collaborators: name: AGRUPARTE S.L.
First posted: 2020-10-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind randomized clinical trial in parallel groups and controlled with standard clinical practice.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Lenght of weaning from mechanical ventilation (hours)
timeFrame: within 1 week
Secondary outcomes:
measure: Sedoanalgesia average dosis
timeFrame: within 1 week (during the weaning)
measure: 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
timeFrame: within 1 week (during the weaning)
measure: 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
timeFrame: within 1 week (during the weaning)
measure: Systolic TA (mm hg) at the beginning, at the end of the intervention, and 30 minutes after the end
timeFrame: within 1 week (during the weaning)
measure: Diastolic TA (mm hg) at the beginning, at the end of the operation, and 30 minutes after the end
timeFrame: within 1 week (during the weaning)
measure: Heart rate (beats/minutes) at the beginning, at the end of the intervention, and 30 minutes after the end
timeFrame: within 1 week (during the weaning)
measure: Breathing frequency at the beginning, at the end of the speech, and 30 minutes after the end
timeFrame: within 1 week (during the weaning)
measure: Oxygen saturation, at the beginning, at the end of the intervention, and 30 minutes after the end
timeFrame: within 1 week (during the weaning)
measure: Perceived Stress Scale (PSS) score
timeFrame: 90 days after the start of the weaning process
measure: Perception of the influence of the Music Therapy Intervention and intervention strategies, through a Semi-structured Interview
timeFrame: 90 days after having started the process of disconnecting the mechanical ventilation (weaning)
Other outcomes:
Locations:
city: Vitoria-gasteiz
country: Spain
facility: Araba university hospital
state: Alava
city: Vitoria
country: Spain
facility: Esther Corral
state: Alava
Study officials:
References: