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

Not Applicable

Completed

• Conditions: Intensive Care Units
• Interventions: Behavioral: Sound isolation / Music therapy

• Registration Number: NCT02040051
• Lead Sponsor: Althaia Xarxa Assistencial Universitària de Manresa

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-17
• Study First Posted: 2014-01-20
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-24
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GROUP A: Sound isolation / Music therapy	Sound isolation / Music therapy	* 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
GROUP B: Music therapy / Sound isolation	Sound isolation / Music therapy	* 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

Primary Outcome Measures

Name	Time	Method
Ramsay sedation scale	Up to 4 hours
Bispectral Index (BIS)	Up to 4 hours
Behaviour Pain Scale (BPS)	Up to 4 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Fundació Althaia Xarxa Assistencial Universitària de Manresa; 🇪🇸 Manresa, Barcelona, Spain