Use of Music and Voice Stimulus on Coma Patients
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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2004
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 13, 2009
CompletedFirst Posted
Study publicly available on registry
August 17, 2009
CompletedJune 11, 2010
August 1, 2009
1.1 years
August 13, 2009
June 10, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Vital signs
3 days; before and after stimulus or silence
Study Arms (1)
silence
PLACEBO COMPARATORThe control group listened "silence" and was evaluated the same things.
Interventions
Experimental group: music and message Control group: silence
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Score between 9 to 15 in GCS or scores R1, R2, R3 or R4 in RSS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
HCFMUSP - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403-000, Brazil
Related Publications (1)
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.
PMID: 19597668RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 13, 2009
First Posted
August 17, 2009
Study Start
February 1, 2004
Primary Completion
March 1, 2005
Study Completion
September 1, 2005
Last Updated
June 11, 2010
Record last verified: 2009-08