Use of Music and Voice Stimulus on Coma Patients
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
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|
- Vital signs [ Time Frame: 3 days; before and after stimulus or silence ] [ Designated as safety issue: No ]
|Study Start Date:||February 2004|
|Study Completion Date:||September 2005|
|Primary Completion Date:||March 2005 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00959829
|HCFMUSP - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo|
|São Paulo, SP, Brazil, 05403-000|