Comparison of the effect of auditory sensory stimulation with familiar and unfamiliar voices in level of consciousness of traumatic comatose patients admitted to ICU, educational and traputic centers of mazandaran university of medical sciences, 2011.
This study is a double blind clinical trial (patient and assessor). The population includes 45 traumatic comatose patients with GCS≤8 with the age range of 15-75, admitted to ICU, training centers of mazandaran university of medical sciences. The sampling method allocated into three groups, one, two and the control. The test takes place among the patients with a tape recording of the voice, group one(stimulation with familial voice) and two (auditory stimulation by researcher introduced as a nurse), two times per day for 5-15 minutes. The control group, but the usual sounds of the environment, stimulation did not receive a hearing. Means of mMeasurement of consciousness of patients are the Glasgow Coma Scale( GCS) which controlled before, during and 2 minutes after the test takes place. These tests are meanwhile also take place for the control group. The time GCS, vtal signs of patients were well controlled.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109247537N1
Registration date:2012-06-07, 1391/03/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-06-07, 1391/03/18
Registrant information
Name
Fereshteh Araghian Mojarad
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1226 7342
Email address
f.araghian@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2011-06-10, 1390/03/20
Expected recruitment end date
2011-12-11, 1390/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of auditory sensory stimulation with familiar and unfamiliar voices in level of consciousness of traumatic comatose patients admitted to ICU, educational and traputic centers of mazandaran university of medical sciences, 2011.
Public title
Auditory stimulation in level of consciousness of comatose patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: GCS≤8; traumatic comatose patient; aged between 15 To 75 years. Exclusion criteria: history of brain trauma; history of hearing loss; affection to diabet & cardiovascular disease& fat emboli; opium and drug addiction; otorrhea, Rhinorrhea; skull fracture or bleeding or surgery in temporal region andfFracture or palsy in all organs or eyelid swelling.
Age
From 15 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Vicen Chancellor of Mazandaran University of Medical Science and Health Services