Use of Music and Voice Stimulus on Coma Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Coma

Intervention / Treatment
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* Other: Music and message


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: silence<br>The control group listened silence and was evaluated the same things. | Other: Music and message<br>* Experimental group: music and message Control group: silence<br>* Other names: Patients in state of coma or induced coma;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs |  | 3 days; before and after stimulus or silence | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Communication, Complementary Therapies, Intensive Care, Ethics