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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:
ClinicalTrials.gov Identifier:
NCT01141790
First Posted: June 11, 2010
Last Update Posted: June 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Sao Paulo
  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 (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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
ClinicalTrials.gov Identifier: NCT01141790     History of Changes
Other Study ID Numbers: FAPESP 06/61338-5
First Submitted: June 10, 2010
First Posted: June 11, 2010
Last Update Posted: June 11, 2010
Last Verified: June 2010

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

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