Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| AGRUPARTE S.L. | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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:
DESIGN: single blind clinical trial in parallel groups, single blind clinical trial.
POPULATION of this study are patients who initiate weaning for ventilation mechanics.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| music therapy intervention | Procedure | Patients will receive a daily music therapy intervention from the beginning until the end of the weaning from mechical ventilation. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Araba university hospital | Recruiting | Vitoria-Gasteiz | Alava | Spain |
Not provided
| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Single-blind randomized clinical trial in parallel groups and controlled with standard clinical practice.
Not provided
Not provided
The person responsable for carrying out the statistical analysis will be blinded
| 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) |
| Esther Corral | Not yet recruiting | Vitoria-Gasteiz | Alava | Spain |
|