NCT02040051
Completed
Not Applicable
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
Althaia Xarxa Assistencial Universitària de Manresa1 site in 1 country82 target enrollmentJune 2013
ConditionsIntensive Care Units
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intensive Care Units
- Sponsor
- Althaia Xarxa Assistencial Universitària de Manresa
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Ramsay sedation scale
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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)
Investigators
Marina Mateu-Capel
Nurse Bachelor
Althaia Xarxa Assistencial Universitària de Manresa
Eligibility Criteria
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
Outcomes
Primary Outcomes
Ramsay sedation scale
Time Frame: Up to 4 hours
Bispectral Index (BIS)
Time Frame: Up to 4 hours
Behaviour Pain Scale (BPS)
Time Frame: Up to 4 hours
Secondary Outcomes
- Blood pressure(Up to 4 hours)
- Respiratory frequency(Up to 4 hours)
- Endotracheal aspirations(Up to 4 hours)
- Heart rate(Up to 4 hours)
- Administration of sedatives drugs(Up to 4 hours)
- Administration of vasodilator and vasoconstrictor drugs(Up to 4 hours)
Study Sites (1)
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