Analysis of Vital, Facial and Muscular Responses Front to Music or Message in Coma, Vegetative State or Sedated Patients

NCT ID: NCT01141790

Last Updated: 2010-06-11

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

Study Classification

INTERVENTIONAL

Brief Summary

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Objectives: (1) To check music or voice message influence on vital signs, facial expressions or muscular tonus of coma, vegetative or sedated patients; (2) To connect the existence of patient's responsiveness with the Glasgow Coma Scale or with the Ramsay Sedation Scale; (3)To evaluate the relation between the response and the score of Glasgow Outcome Scale.

Detailed Description

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Conditions

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Consciousness Disorders Communication Intensive Care

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Silence

The control group listened "silence" and was evaluated the same things.

Group Type PLACEBO_COMPARATOR

Music and voice message

Intervention Type OTHER

Interventions

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Music and voice message

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* To be in disorder of consciousness;
* To be evaluated according to one of the Scales and to have a score in the study range: in physiological comas, score between 3 to 8 Glasgow Coma Scale (GCS); in induced coma, one of the last two scores of Ramsay Sedation Scale (RSS), R5 or R6;
* To have hearing function preserved according to family;
* To have written consent from the family or responsible party for the patient's participation

Exclusion Criteria

* Score between 9 to 15 in GCS or scores R1, R2, R3 or R4 in RSS
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Locations

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HCFMUSP - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Related Links

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http://[email protected]

website of principal investigator

Other Identifiers

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FAPESP 06/61338-5

Identifier Type: -

Identifier Source: org_study_id

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