Analysis of Vital, Facial and Muscular Responses Front to Music or Message in Coma, Vegetative State or Sedated Patients

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT01141790

Collaborator

(none)

Location

Arm

Study Details

Study Description

Brief Summary

Objectives: (1) To check music or voice message influence on vital signs, facial expressions or muscular tonus of coma, vegetative or sedated patients; (2) To connect the existence of patient's responsiveness with the Glasgow Coma Scale or with the Ramsay Sedation Scale; (3)To evaluate the relation between the response and the score of Glasgow Outcome Scale.

Condition or Disease	Intervention/Treatment	Phase
Consciousness Disorders Communication Intensive Care	Other: Music and voice message	N/A

Study Design

Study Type:

Interventional

Allocation:

Randomized

Masking:

Single (Investigator)

Primary Purpose:

Supportive Care

Official Title:

Analysis of Vital, Facial and Muscular Responses Front to Music or Message in Coma, Vegetative State or Sedated Patients

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Silence The control group listened "silence" and was evaluated the same things.	Other: Music and voice message

Arm

Intervention/Treatment

Placebo Comparator: Silence

The control group listened "silence" and was evaluated the same things.

Other: Music and voice message

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

To be in disorder of consciousness;
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