Use of Music and Voice Stimulus on Coma Patients

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.

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Key information

Conditions

Coma Behavior Communication Consciousness Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Unconsciousness

Age range

16 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HCFMUSP - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, 05403-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music and message

Other

Experimental group: music and message Control group: silence

Other names: Patients in state of coma or induced coma

Primary outcomes

Vital signs

Time frame: 3 days; before and after stimulus or silence

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2005
Study completion: 2005
First posted: Aug 17, 2009
Registry last updated: Jun 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed