Clinical Trials Directory

Trials / Completed

CompletedNCT00959829

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
University of Sao Paulo · Academic / Other
Sex
All
Age
16 Years – 89 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERMusic and messageExperimental group: music and message Control group: silence

Timeline

Start date
2004-02-01
Primary completion
2005-03-01
Completion
2005-09-01
First posted
2009-08-17
Last updated
2010-06-11

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT00959829. Inclusion in this directory is not an endorsement.