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: (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	Intervention
Coma	Other: Music and message

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Coma

U.S. FDA Resources

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
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

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
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

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:	Ana Claudia Giesbrecht Puggina, Escola de Enfermagem da Universidade de São Paulo
ClinicalTrials.gov Identifier:	NCT00959829 History of Changes
Other Study ID Numbers:	FAPESP 03/10035-4
Study First Received:	August 13, 2009
Last Updated:	June 10, 2010
Health Authority:	Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:

Communication
Complementary Therapies
Intensive Care
Ethics

Additional relevant MeSH terms:

Coma
Cogan Syndrome
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases

Signs and Symptoms
Vestibulocochlear Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012