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Clinical Trials/NCT02040051
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

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)

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
June 2014
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Althaia Xarxa Assistencial Universitària de Manresa
Responsible Party
Principal Investigator
Principal Investigator

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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