Use of Music and Voice Stimulus on Coma Patients

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00959829
First received: August 13, 2009
Last updated: June 10, 2010
Last verified: August 2009
  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:


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:
Publications:
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
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014