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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-06-30

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)

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Detailed Description

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Conditions

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Intensive Care Units

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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GROUP A: 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 Type ACTIVE_COMPARATOR

Sound isolation / Music therapy

Intervention Type BEHAVIORAL

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)

GROUP B: Music therapy / Sound isolation

* 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

Group Type ACTIVE_COMPARATOR

Sound isolation / Music therapy

Intervention Type BEHAVIORAL

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)

Interventions

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Sound isolation / Music therapy

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)

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No