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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014