Use of Music and Voice Stimulus on Coma Patients

Coma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00959829
• Other study ID #: FAPESP 03/10035-4
• Status: Completed
• Phase: N/A
• First received: August 13, 2009
• Last updated: June 10, 2010
• Start date: February 2004
• Est. completion date: September 2005

Study information

• Verified date: August 2009
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 89 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Coma

Intervention

Other:
• Music and message
Experimental group: music and message Control group: silence

Locations

Country	Name	City	State
Brazil	HCFMUSP - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & 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. Portuguese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vital signs		3 days; before and after stimulus or silence	No

External Links

•   website of principal investigator