Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04602182
Status:
UNKNOWN
Last Update Posted:
2021-12-27
First Post:
2020-10-20
Brief Title:
Effectiveness of Musicotherapy in Weaning From Mechanical Ventilation
Sponsor:
Basque Health Service
Organization:
Basque Health Service
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2021-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Control group Patient will follow the usual clinical practice for the weaning from mecanichal ventilation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None