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Use of Music and Voice Stimulus on Coma Patients

U

University of Sao Paulo

Status

Completed

Conditions

Coma

Treatments

Other: Music and message

Study type

Interventional

Funder types

Other

Identifiers

NCT00959829
FAPESP 03/10035-4

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

16 to 89 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 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 message

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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