Effectiveness of Musicotherapy in Weaning From Mechanical Ventilation

EFFECTS OF AN INTERVENTION WITH MUSICOTHERAPY IN THE WEANING FROM MECHANICAL VENTILATION IN PATIENTS OF THE INTENSIVE MEDICINE UNIT OF THE ALAVA UNIVERSITY HOSPITAL

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.

Study Overview

• Status: Recruiting
• Conditions: Respiration, Artificial; Weaning; Music Therapy
• Intervention / Treatment: Procedure: music therapy intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alava
    • Vitoria, Alava, Spain
      • Not yet recruiting
      • Esther Corral
      • Contact: ESTHER CORRAL; Email: ESTHER.CORRALLOZANO@osakidetza.eus
    • Vitoria-gasteiz, Alava, Spain
      • Recruiting
      • Araba University Hospital
      • Contact: ESTHER CORRAL; Phone Number: +34945007000; Email: ESTHER.CORRALLOZANO@osakidetza.eus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: music therapy intervention; Patients will receive a daily music therapy intervention from the beginning until the end of the weaning from mechical ventilation.
Active Comparator: control group; 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; Patients will receive a daily music therapy intervention from the beginning until the end of the weaning from mechical ventilation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lenght of weaning from mechanical ventilation (hours)	Time in hours from the beginning to the end of the disconnection process	within 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	RASS scoring and interpretation should be based on the sedation protocol being used. For minimal sedation protocols (RASS -2 to 0), sedation should be modified or decreased for a RASS score of -3 or less.[3] Scores of 2 to 4 may indicate under-sedation. At minimum, the patient should be assessed for pain, delirium, and anxiety. In addition, other underlying causes of agitation should be investigated and treated as appropriate. In select cases, a deep sedation protocol (RASS -4 and -5) may be used.[3] For scores of -3 or higher, sedation should be modified to achieve the desired range	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	Rate each symptom of delirium listed in the instrument as absent (0), mild (1), or marked (2), except acute onset or fluctuating course which was rated as absent (0) or present (1). The severity score is created by an additive summary of the ratings ranging from 0-7 (short form) and 0-19 (long form). Higher scores indicate more severe delirium.	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)
Heart rate (beats/minutes) at the beginning, at the end of the intervention, and 30 minutes after the end		within 1 week (during the weaning)
Breathing frequency at the beginning, at the end of the speech, and 30 minutes after the end		within 1 week (during the weaning)
Oxygen saturation, at the beginning, at the end of the intervention, and 30 minutes after the end		within 1 week (during the weaning)
Perceived Stress Scale (PSS) score	Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceivedstress. ►Scores ranging from 0-13 would be considered low stress. ►Scores ranging from 14-26 would be considered moderate stress.►Scores ranging from 27-40 would be considered high perceived stress.	90 days after the start of the weaning process
Perception of the influence of the Music Therapy Intervention and intervention strategies, through a Semi-structured Interview		90 days after having started the process of disconnecting the mechanical ventilation (weaning)

Collaborators and Investigators

• Sponsor: Basque Health Service
• Collaborators: AGRUPARTE S.L.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2020
• Primary Completion (Actual): October 19, 2021
• Study Completion (Anticipated): June 19, 2022

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 26, 2020

Study Record Updates

• Last Update Posted (Actual): December 27, 2021
• Last Update Submitted That Met QC Criteria: December 23, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: MusicoT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No