Use of Music and Voice Stimulus on Coma Patients

Use of Music and Vocal Stimulus in Patients in Coma State - Relations Between Auditory Stimulus, Vital Signs, Face Expression and Glasgow Coma Scale or Ramsay Scale

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00959829

Enrollment

Registered

2009-08-17

Start date

2004-02-29

Completion date

2005-09-30

Last updated

2010-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coma

Keywords

Communication, Complementary Therapies, Intensive Care, Ethics

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.

Interventions

OTHERMusic and message

Experimental group: music and message Control group: silence

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

16 Years to 89 Years

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

Design outcomes

Primary

Measure	Time frame
Vital signs	3 days; before and after stimulus or silence

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026