Use of Music and Voice Stimulus on Coma Patients
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Coma |
Other: Music and message |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Supportive Care |
| Official 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 |
- Vital signs [ Time Frame: 3 days; before and after stimulus or silence ] [ Designated as safety issue: No ]
| Enrollment: | 30 |
| Study Start Date: | February 2004 |
| Study Completion Date: | September 2005 |
| Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: silence
The control group listened "silence" and was evaluated the same things.
|
Other: Music and message
Experimental group: music and message Control group: silence
Other Name: Patients in state of coma or induced coma
|
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.
Eligibility| Ages Eligible for Study: | 16 Years to 89 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Ana Claudia Giesbrecht Puggina, Escola de Enfermagem da Universidade de São Paulo |
| ClinicalTrials.gov Identifier: | NCT00959829 History of Changes |
| Other Study ID Numbers: | FAPESP 03/10035-4 |
| Study First Received: | August 13, 2009 |
| Last Updated: | June 10, 2010 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by University of Sao Paulo:
|
Communication Complementary Therapies Intensive Care Ethics |
Additional relevant MeSH terms:
|
Coma Cogan Syndrome Unconsciousness Consciousness Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Vestibulocochlear Nerve Diseases Cranial Nerve Diseases Eye Diseases Vasculitis Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013