Use of Music and Voice Stimulus on Coma Patients

Not Applicable

Completed

• Conditions: Coma
• Interventions: Other: Music and message

• Registration Number: NCT00959829
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

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.

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2005-03
• Study Completion: 2005-09
• Status Verified: 2009-08
• Study First Submitted: 2009-08-13
• Study First Submitted QC: 2009-08-14
• Study First Posted: 2009-08-17
• Last Update Submitted: 2010-06-10
• Last Update Posted: 2010-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Vital signs	3 days; before and after stimulus or silence

Trial Locations

Locations (1)

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