Back to resultsAnalysis of Vital, Facial and Muscular Responses Front to Music or Message in Coma, Vegetative State or Sedated Patients
Primary Purpose
Consciousness Disorders, Communication, Intensive Care
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Music and voice message
Sponsored by
About this trial
This is an interventional supportive care trial for Consciousness Disorders focused on measuring Glasgow Coma Scale, Glasgow Outcome Scale, Ethics
Eligibility 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
Sites / Locations
- HCFMUSP - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
Arms of the Study
Arm 1
Arm Type
Placebo Comparator
Arm Label
Silence
Arm Description
The control group listened "silence" and was evaluated the same things.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01141790
Brief Title
Analysis of Vital, Facial and Muscular Responses Front to Music or Message in Coma, Vegetative State or Sedated Patients
Official Title
Analysis of Vital, Facial and Muscular Responses Front to Music or Message in Coma, Vegetative State or Sedated Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Consciousness Disorders, Communication, Intensive Care
Keywords
Glasgow Coma Scale, Glasgow Outcome Scale, Ethics
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Masking
Investigator
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
Silence
Arm Type
Placebo Comparator
Arm Description
The control group listened "silence" and was evaluated the same things.
Intervention Type
Other
Intervention Name(s)
Music and voice message
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
HCFMUSP - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
City
São Paulo
State/Province
SP
Country
Brazil
12. IPD Sharing Statement
Links:
URL
http://claudiapuggina@usp.br
Description
website of principal investigator
Learn more about this trial
Analysis of Vital, Facial and Muscular Responses Front to Music or Message in Coma, Vegetative State or Sedated Patients
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