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

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01141790
First received: June 10, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Consciousness Disorders
Communication
Intensive Care
 Other: Music and voice message

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Analysis of Vital, Facial and Muscular Responses Front to Music or Message in Coma, Vegetative State or Sedated Patients

Resource links provided by NLM:

MedlinePlus related topics: Coma
U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Arms Assigned Interventions
Placebo Comparator: Silence
The control group listened "silence" and was evaluated the same things.
 Other: Music and voice message

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01141790

Locations
Brazil
HCFMUSP - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, SP, Brazil
Sponsors and Collaborators
University of Sao Paulo
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01141790     History of Changes
Other Study ID Numbers: FAPESP 06/61338-5
Study First Received: June 10, 2010
Last Updated: June 10, 2010
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Glasgow Coma Scale
Glasgow Outcome Scale
Ethics

Additional relevant MeSH terms:
Consciousness Disorders
Persistent Vegetative State
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
 Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Unconsciousness

ClinicalTrials.gov processed this record on May 23, 2013