Use of Music and Voice Stimulus on Coma Patients
|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.|
|ClinicalTrials.gov Identifier: NCT00959829|
Recruitment Status : Completed
First Posted : August 17, 2009
Last Update Posted : June 11, 2010
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.
|Condition or disease||Intervention/treatment|
|Coma||Other: Music and message|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|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 Start Date :||February 2004|
|Primary Completion Date :||March 2005|
|Study Completion Date :||September 2005|
Placebo Comparator: silence
The control group listened "silence" and was evaluated the same things.
Other: Music and message
Experimental group: music and message Control group: silence
Other Name: Patients in state of coma or induced coma
- Vital signs [ Time Frame: 3 days; before and after stimulus or silence ]
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): NCT00959829
|HCFMUSP - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo|
|São Paulo, SP, Brazil, 05403-000|