Back to resultsUse of Music and Voice Stimulus on Coma Patients
Primary Purpose
Coma
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Music and message
Sponsored by
About this trial
This is an interventional supportive care trial for Coma focused on measuring Communication, Complementary Therapies, Intensive Care, Ethics
Eligibility Criteria
Inclusion Criteria:
- To be in coma;
- 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 in the research.
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
Vital signs
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00959829
Brief Title
Use of Music and Voice Stimulus on Coma Patients
Official Title
Use of Music and Vocal Stimulus in Patients in Coma State - Relations Between Auditory Stimulus, Vital Signs, Face Expression and Glasgow Coma Scale or Ramsay Scale
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
September 2005 (Actual)
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 and voice message influence on vital signs and facial expressions of patients in physiological or induced comas; (2) To connect the existence of patient's responsiveness with the Glasgow Coma Scale or with the Ramsay Sedation Scale.
Method: This was a randomized controlled clinical trial with 30 patients, from two Intensive Care Units, being divided in 2 groups (control and experimental). Their relatives recorded a voice message and chose a song according to the patient's preference. The patients were submitted to 3 sessions for 3 consecutive days.
Detailed Description
The relatives elaborated a voice recorded message and choose a music according to the patient preference, which were recorded in the same Compact Disc. Two identical CD's were made at the same recorded time; one with and another one without stimulus in order to make the random division of the groups. The patients were evaluated according to one of the Scales; they used earphones. During the sessions, the data relating to the vital signs and the face expression were recorded in a data collection instrument.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coma
Keywords
Communication, Complementary Therapies, Intensive Care, Ethics
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)
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 message
Other Intervention Name(s)
Patients in state of coma or induced coma
Intervention Description
Experimental group: music and message Control group: silence
Primary Outcome Measure Information:
Title
Vital signs
Time Frame
3 days; before and after stimulus or silence
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
To be in coma;
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 in the research.
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
ZIP/Postal Code
05403-000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
19597668
Citation
Puggina AC, Silva MJ. [Vital signs and facial expression of patients in coma]. Rev Bras Enferm. 2009 May-Jun;62(3):435-41. doi: 10.1590/s0034-71672009000300016. Portuguese.
Results Reference
result
Learn more about this trial
Use of Music and Voice Stimulus on Coma Patients
We'll reach out to this number within 24 hrs