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NCT01141790 Clinical Trial

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

Communication Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01141790
Other study ID # FAPESP 06/61338-5
Secondary ID
Status Completed
Phase N/A
First received June 10, 2010
Last updated June 10, 2010

Study information
Verified date June 2010
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Other:
• Music and voice message

Locations
Country Name City State
Brazil HCFMUSP - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo São Paulo SP

Sponsors (1)
Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

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