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

Not Applicable

Completed

• Conditions: Consciousness Disorders; Communication; Intensive Care
• Interventions: Other: Music and voice message

• Registration Number: NCT01141790
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-06
• Study First Submitted: 2010-06-10
• Study First Submitted QC: 2010-06-10
• Last Update Submitted: 2010-06-10
• Study First Posted: 2010-06-11
• Last Update Posted: 2010-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Silence	Music and voice message	The control group listened "silence" and was evaluated the same things.

Trial Locations

Locations (1)

HCFMUSP - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo; 🇧🇷 São Paulo, SP, Brazil