Efficacy of Sound Insulation and Music Therapy on the Comfort of Mechanically Ventilated Patients Admitted to Intensive Care Unit

Study Overview
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Brief Summary
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The purpose of this study is to assess the effect of sound insulation and music therapy on the comfort of mechanically ventilated patients admitted to intensive care unit measured by the Bispectral Index (BIS), the Ramsay sedation scale and the Behaviour Pain Scale (BPS)

Official Title
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Randomized Clinical Trial to Assess the Effect of Sound Insulation and Music Therapy on the Comfort of Mechanically Ventilated Patients Admitted to Intensive Care Unit

Conditions
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Intensive Care Units

Intervention / Treatment
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* Behavioral: Sound isolation / Music therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of both sexes Patients over 18 years old Patients with a level of consciousness BIS ≥ 50 Exclusion Criteria: Patients with withholding treatment Patients with partial or complete reduction of hearing in one or both ears Patients with altered mental states: psychosis, schizophrenia, paranoia, neurosis, etc. Patients with acute disease of the central nervous system: stroke, coma, encephalopathic process, etc. Patients with an axillary temperature > 37.5º

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GROUP A: Sound isolation / Music therapy<br>PREINTERVENTION: First hour. The patient will remain under the usual conditions of intensive care unit INTERVENTION: Second hour. Sound isolation INTERVENTION: Third hour. Music therapy POSTINTERVENTION: Fourth hour. The patient will remain under the usual conditions of intensive care unit | Behavioral: Sound isolation / Music therapy<br>* Sound isolation: we will used headphones Noise Candelling HI-FI Polk Audio UF 8000 Control Talk for sound isolation. Music therapy: we will used relaxing Zen music. Light Reiki Touch (Album: Merlin's Magic; Composer: Andreas Mock. Published in 1995 by Inner Worl Music)<br>|
| Active Comparator: GROUP B: Music therapy / Sound isolation<br>PREINTERVENTION: First hour. The patient will remain under the usual conditions of intensive care unit INTERVENTION: Second hour. Music therapy INTERVENTION: Third hour. Sound isolation POSTINTERVENTION: Fourth hour. The patient will remain under the usual conditions of intensive care unit | Behavioral: Sound isolation / Music therapy<br>* Sound isolation: we will used headphones Noise Candelling HI-FI Polk Audio UF 8000 Control Talk for sound isolation. Music therapy: we will used relaxing Zen music. Light Reiki Touch (Album: Merlin's Magic; Composer: Andreas Mock. Published in 1995 by Inner Worl Music)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bispectral Index (BIS) |  | Up to 4 hours | 
| Ramsay sedation scale |  | Up to 4 hours | 
| Behaviour Pain Scale (BPS) |  | Up to 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | Up to 4 hours | 
| Heart rate |  | Up to 4 hours | 
| Respiratory frequency |  | Up to 4 hours | 
| Endotracheal aspirations |  | Up to 4 hours | 
| Administration of sedatives drugs |  | Up to 4 hours | 
| Administration of vasodilator and vasoconstrictor drugs |  | Up to 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intensive care units, mechanical ventilation, music therapy