Use of Music and Voice Stimulus on Coma Patients - Full Text View

Sponsor:	University of Sao Paulo
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00959829

Purpose

Objectives:

To check music and voice message influence on vital signs and facial expressions of patients in physiological or induced comas; 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	Intervention
Coma	Other: Music and message

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Single Blind (Investigator), Placebo Control, Parallel Assignment
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

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

Vital signs [ Time Frame: 3 days; before and after stimulus or silence ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	February 2004
Study Completion Date:	September 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
silence: Placebo Comparator The control group listened "silence" and was evaluated the same things.	Other: Music and message Experimental group: music and message Control group: silence

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.

Eligibility

Ages Eligible for Study:	16 Years to 89 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959829

Locations

Brazil, SP
HCFMUSP - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, SP, Brazil, 05403-000

Sponsors and Collaborators

University of Sao Paulo

Investigators

Principal Investigator:

Ana CG Puggina, Master

Escola de Enfermagem da Universidade de São Paulo

More Information

Additional Information:

website of principal investigator This link exits the ClinicalTrials.gov site

Publications:

Puggina AC, Silva MJ. [Vital signs and facial expression of patients in coma.] Rev Bras Enferm. 2009 May-Jun;62(3):435-41. Portuguese.

Responsible Party:	Escola de Enfermagem da Universidade de São Paulo ( Ana Claudia Giesbrecht Puggina )
Study ID Numbers:	FAPESP 03/10035-4
Study First Received:	August 13, 2009
Last Updated:	August 14, 2009
ClinicalTrials.gov Identifier:	NCT00959829 History of Changes
Health Authority:	Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:

Communication
Complementary Therapies
Intensive Care
Ethics

Additional relevant MeSH terms:

Coma
Signs and Symptoms
Unconsciousness
Nervous System Diseases

Consciousness Disorders
Neurologic Manifestations
Neurobehavioral Manifestations

ClinicalTrials.gov processed this record on February 08, 2010