This study aimed to investigate the effect of sensory stimulation program on the level of consciousness and physiological responses of patients with brain injury will be done.The study population included all patients admitted with a diagnosis of brain injury,Inclusion criteria: GCS less than 8, aged 15-65 years, the absence of sensory disorders in patients,and Exclusion criteria included : cerebral ischemia (confirmed by imaging studies), cardiac arrest, more than 4 minutes after admission. The sample consisted of 60 patients will be studied.The intervention involves the creation of various sensory stimulation for 6 days and 5 times per day will be two-hour intervals. Each intervention period lasts 30 minutes. Expected outcomes will be include changes in the level of consciousness after the intervention and changes in physiological variables, including: HR, RR, o2 SAT and systolic and diastolic blood pressure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014031116942N1
Registration date:2015-11-25, 1394/09/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-25, 1394/09/04
Registrant information
Name
shiva monfared
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 3025
Email address
sh.monfared@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kerman University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of sensory stimulation programs on level of consciousness and Physiological parameters in patients with head injury in intensive care units
Public title
The effect of sensory stimulation on the level of consciousness and physiological parameters
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of head trauma, GCS 8 and less than 8, aged 15-65 years, the absence of sensory disorders in patients (impaired sense of hearing, sight, smell, touch and taste)
Exclusion criteria included : cerebral ischemia (confirmed by imaging studies), cardiac arrest, more than 4 minutes after admission
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Tahmasebabad Crossroads, Kerman
City
kerman
Postal code
Approval date
2015-01-31, 1393/11/11
Ethics committee reference number
k/93/295
Health conditions studied
1
Description of health condition studied
trumatic brain injury
ICD-10 code
S09.9
ICD-10 code description
For primary coding of intracranial injuries with associated fractures, reference should be made to the morbidity or mortality coding rules and guidelines in Volume 2.
Primary outcomes
1
Description
level of Consciousness
Timepoint
Before and after each intervention.
Method of measurement
GCS and FOUR score
2
Description
blood pressure
Timepoint
Before and after each intervention.
Method of measurement
mm Hg and by cuff pressure of bed side monitoring device
3
Description
heart rate
Timepoint
Before and after each intervention.
Method of measurement
number / minute and by bed side monitoring device
4
Description
respiratory rate
Timepoint
Before and after each intervention.
Method of measurement
number / minute
5
Description
Arterial oxygen saturation
Timepoint
Before and after each intervention.
Method of measurement
In percentage terms, and by pulse oxymeter
Secondary outcomes
empty
Intervention groups
1
Description
For control group did not perform any intervention and Patients affected by normal environmental stimulations.
Category
Rehabilitation
2
Description
Interventions in intervention group is a program consisted of sensory stimulation including :Tactile Gustatory, olfactory,auditory, visual and Kinetic Stimulation.Intervention done by the researcher for 6 days and 5 times per day.There is a 2-hour interval between the interventions.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ibn Abi Talib Hospital in Rafsanjan
Full name of responsible person
Shiva Monfared Parizi
Street address
City
Rafsanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Kerman University of Medical Sciences ,Physiology Research Center
Full name of responsible person
Abass pardakhty
Street address
Physiology Research Center, Kerman University of Medical Sciences, Tahmassbabad, Kerman
City
Kerman
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,Kerman University of Medical Sciences ,Physiology Research Center
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
Kerman University of Medical Sciences
Full name of responsible person
Hakimeh Hosseirezai
Position
Member of Kerman University of Medical Sciences
Other areas of specialty/work
Street address
beginning of the road HAFTBAGH, Kerman University of Medical Sciences, Kerman,Iran
City
Kerman
Postal code
Phone
+98 343205177
Fax
Email
H_m5664@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Shiva Monfared parizi
Position
Critical Care Nursing Graduate
Other areas of specialty/work
Street address
Beginning of the road HAFTBAGH, Kerman University of Medical Sciences, Kerman,Iran
City
Kerman
Postal code
Phone
+98 34 3425 0563
Fax
Email
shmonfared1391@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Shiva Monfared Parizi
Position
Critical Care Nursing Graduate
Other areas of specialty/work
Street address
Beginning of the road HAFTBAGH, Kerman University of Medical Sciences, Kerman,Iran
City
Kerman
Postal code
Phone
00
Fax
Email
shmonfared1391@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)