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

U

University of Sao Paulo

Status

Completed

Conditions

Communication
Consciousness Disorders
Intensive Care

Treatments

Other: Music and voice message

Study type

Interventional

Funder types

Other

Identifiers

NCT01141790
FAPESP 06/61338-5

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

Exclusion criteria

  • Score between 9 to 15 in GCS or scores R1, R2, R3 or R4 in RSS

Trial design

0 participants in 1 patient group, including a placebo group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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