Effect of structured auditory stimulation on the level of consciousness in patients' comatose in intensive care unit with head trauma admitted to hospital 5th Azar
The purpose of this clinical trial is determining of the Effect of structured auditory stimulation on the level of consciousness in patients' comatose in intensive care unit with head trauma. The samples will be selected from comatose patients that would have admitted in the intensive care units of Panje Azar hospital of Gorgan , Iran. Then, the samples through an allocated randomizing Designed to case and control groups. The sample size is 40 head trauma comatose patients (20 interventional and 20 controls) that randomly allocated to the two groups. The study is double blind and Inclusion criteria are age of 15-60, GCS under 8 score, after 24 hours of admitting and after stabling of vital sign. Duration of intervention is 10 days and every day 3 times (in three shifts). Every auditory intervention is 15 minutes. A male nurse voice will be recorded and broadcasted for each patient as auditory stimulation. The content of auditory stimulation for each subject includes time, place, individual orientation, and individual demographic, family members’ demographic and professional condition.
The GCS of each subject is monitored and recorded before and 30 minutes after auditory stimulation by an educated nurse. Moreover, hemodynamic function is assessed such as pulse and respiratory rate, blood pressure before and after auditory stimulation. Also, in the subjects as control group all of them are monitored without auditory stimulation. the data compare through statistic tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012071810325N1
Registration date:2012-08-06, 1391/05/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-08-06, 1391/05/16
Registrant information
Name
Gholamreza Mahmoodi Shan
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1442 6900
Email address
mahmoudi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan university of Medical sciences
Expected recruitment start date
2012-07-25, 1391/05/04
Expected recruitment end date
2012-10-06, 1391/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of structured auditory stimulation on the level of consciousness in patients' comatose in intensive care unit with head trauma admitted to hospital 5th Azar
Public title
Effect of structured auditory stimulation on the level of consciousness in patients' comatose with head trauma
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: the admitted comatose patients in ICU with head trauma in the Panje Azar hospital of Gorgan , Iran who have the following criteria will be selected: GCS≤8, no have disorder or decrease in auditory function, no heart arrested for 4 minutes or upper, no having Precedence of : convulsion, brain damage, cardiovascular disease, fatty embolism, Rhinorrhea, otorrhea, fracture of basal skull, hemorrhage or surgery in temporal.
exclusion criteria:Early death (before 10 days, early discharge, disagreement of the responsible of patient for continuing of intervention, and auditory disorder.
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Ethical committee of Golestan university of Medical sciences
Street address
Golestan university of Medical sciences; kilometer 2 Gorgan-sari ,Gorgan, Iran.
City
Gorgan
Postal code
4934172515
Approval date
2012-05-22, 1391/03/02
Ethics committee reference number
534/35/پگ
Health conditions studied
1
Description of health condition studied
comatose patients with head trauma
ICD-10 code
VI-S00-T98
ICD-10 code description
Diseases of the nervous system-injury, poisoning and certain other consequences of external causes
Primary outcomes
1
Description
level of consciousness
Timepoint
One time in each shift ( 3 times per 24 hours)
Method of measurement
GCS criteria
Secondary outcomes
1
Description
blood pressure
Timepoint
3 times in 24 hours
Method of measurement
blood pressure monitored based on mm Hg
2
Description
pulse
Timepoint
3 times in 24 hours
Method of measurement
pulse rate( counting) per minute
3
Description
respiratory rate
Timepoint
3 times in 24 hours
Method of measurement
counting respiratory rate per minute
4
Description
O2 saturation
Timepoint
3 times in 24 hours
Method of measurement
the percent of hemoglobine o2 saturatin
Intervention groups
1
Description
Duration of intervention is 10 days and every day 3 times (in three shifts). Every auditory intervention is 15 minutes. A male nurse voice will be recorded and broadcasted for each patient as auditory stimulation. The content of auditory stimulation for each subject includes time, place, individual orientation, and individual demographic, family members’ demographic and professional condition.
Category
Prevention
2
Description
In the control group ther is no intervention and patients recieve standard care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
5 Azar hospital
Full name of responsible person
Gholamreza Mahmoodi Shan
Street address
Golestan university of Medical sciences; kilometer 2 Gorgan-sari ,Gorgan, Iran.
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research and technology, Golestan university of Medical sciences
Full name of responsible person
mohsen arabi
Street address
kilometer 2 Gorgan-sari ,Gorgan, Iran.
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research and technology, Golestan university of Medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Gholamreza Mahmoodi Shan
Position
Doctoral(PhD)/Assisstant professor
Other areas of specialty/work
Street address
kilometer 2 Gorgan-sari ,Gorgan, Iran.
City
Gorgan
Postal code
49165-568
Phone
+98 17 1442 6900
Fax
+98 17 1442 5171
Email
Mahmoudi@goums.ac.ir; Mahmoodigh@yahoo.com
Web page address
www.Goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Gholamreza Mahmoodi Shan
Position
Doctoral(PhD)/Assisstant professor
Other areas of specialty/work
Street address
kilometer 2 Gorgan-sari ,Gorgan, Iran.
City
Gorgan
Postal code
49165-568
Phone
+98 17 1442 6900
Fax
+98 17 1442 5171
Email
Mahmoudi@goums.ac.ir; Mahmoodigh@yahoo.com
Web page address
www.goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Gholamreza Mahmoodi Shan
Position
Doctoral(PhD)/Assisstant professor
Other areas of specialty/work
Street address
kilometer 2 Gorgan-sari ,Gorgan, Iran
City
Gorgan
Postal code
Phone
+98 17149165
Fax
+98 17 1442 5171
Email
mahmoudu@goums.ac.ir; mahmoodigh@yahoo.com
Web page address
www.goums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)