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

Althaia Xarxa Assistencial Universitària de Manresa

Status: Completed

Conditions: Intensive Care Units

Treatments: Behavioral: Sound isolation / Music therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02040051

CEIC 13/36

Details and patient eligibility

About

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)

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

GROUP A: Sound isolation / Music therapy

Active Comparator group

Description:

* 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

Treatment:

Behavioral: Sound isolation / Music therapy

GROUP B: Music therapy / Sound isolation

Active Comparator group

Description:

* 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

Treatment:

Behavioral: Sound isolation / Music therapy