Survey of the effect of temperature reduction of prefrontal area on accuracy of visual sustained attention in two groups of intervention and control students of Shiraz University of Medical Sciences
Design
Sample size: 38 male students of Shiraz University of Medical Sciences aged 20 to 35 years
Two groups of intervention and control with equal number in each group
Assignment of samples in two groups of control and intervention, randomly and by permutation block method
Settings and conduct
The scientific field of this project is neuroergonomics and the location of this research is in the Faculty of Modern Science of Shiraz University of Medical Sciences. This study is done in 3 phases.The first phase consists of primary physiological and cognitive assessments, the second phase involves reducing the temperature of the forehead in the intervention group and the third phase includes physiological and cognitive reassessment in both intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-The consent of the individual to participate in the study
2-Spend breakfast or 250 cc water
3-Adequate sleep for at least 6 hours before the assessment session
4-Having a normal binocular or 10/10
5-Obtain score 0 to 22 from the Goldberg & Hiller General Health Questionnaire
6-Male gender
Exclusion criteria
1-Creation of headache in the prefrontal temperature reduction phase
2-Creation of anxiety state in the phase of temperature reduction of the prefrontal
3-Creation of nausea and dizziness in the prefrontal temperature reduction phase
Intervention groups
The intervention group includes students who receive interventions to reduce the temperature of the prefrontal area.
The control group includes students who do not receive intervention.
Main outcome variables
accuracy of visual sustained attention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181203041830N1
Registration date:2019-03-26, 1398/01/06
Registration timing:registered_while_recruiting
Last update:2019-03-26, 1398/01/06
Update count:0
Registration date
2019-03-26, 1398/01/06
Registrant information
Name
sajad mohsenian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3333 8129
Email address
mohsenian_sajad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of the effect of temperature reduction of prefrontal area on accuracy of visual sustained attention in two groups of intervention and control
Public title
Effect of Brain temperature reduction on visual attention
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The informed consent of the individual to participate in the study
Spend breakfast or 250 cc water
Adequate sleep for at least 6 hours before the assessment session
Having a normal binocular or 10/10
Male gender
Exclusion criteria:
The absence of disease or brain damage
The absence of heart problems
No use of blood pressure regulating drugs
The absence of acute and chronic sinusitis
Missing migraine headache
The absence of anxiety
Do not drink alcohol, nicotine and coffee at least 24 hours before the assessment
No drug abuse
Age
From 20 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized blocks are assigned to control and intervention groups. Therefore, in this study, the block is formed and defined, and the layers and clusters are not considered. However, in this study, 19 binary blocks (38 observations) are used, while in order to be more cautious and prevent known The grandson of the intervention for the second person in each block will use 9 blocks of four and 1 binary block. It is worth noting that the order of the crash in each block is determined using the software R.
Blinding (investigator's opinion)
Single blinded
Blinding description
In single-blind design, since the subjects are not informed about the intended intervention, bias and error are controlled in the reports. This study is a one-way blind study. That is, although at the beginning of the study, the informed consent is completed by all the participants in the study, the individual himself does not know the type of intervention that will be used.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Street of Qasr al-Dasht - between the streets of Palestine and Mulla Sadra - Pillar 29 - Diamond building - 1st and 2nd floors of the building
City
Shiraz
Province
Fars
Postal code
novinmed@sums.ac.ir
Approval date
2019-01-13, 1397/10/23
Ethics committee reference number
IR.SUMS.REC.1397.998
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Visual sustained attention is the ability of the observer to detect non-recurrent and unpredictable triggers over a long period of time during cognitive work.
Timepoint
Assessment of persistent vision attention in the first, second and third phase of the study
Method of measurement
Visual sustained attention is evaluated by standardized test set-up of the CANTAB.
Secondary outcomes
1
Description
The skin temperature of the prefrontal area
Timepoint
In the first, second and third phase of the study
Method of measurement
Polygeraghy sensor
2
Description
The amount of blood flow of prefrontal cortex
Timepoint
In the first, second and third phase of the study
Method of measurement
Hemoencephalography device
Intervention groups
1
Description
Intervention group:Reducing the temperature of the prefrontal area for one hour is done to reduce the temperature of the prefrontal cortex by using a temperature-reducing device cap. The coolant temperature is 4 degrees Celsius.
Category
Other
2
Description
Control group: For this group, the temperature control device is covered on the forging area, but no coolant fluid is present in this coating (Placebo effect).
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz university of medical sciences
Full name of responsible person
sajad mohsenian
Street address
Zand Street;SUMS.
City
Shiraz
Province
Fars
Postal code
143361 - 71348
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Zand Street;SUMS
City
shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
zahra zamanian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Ergonomics
Street address
Razi Blvd. School of Health
City
shiraz
Province
Fars
Postal code
071-37251001
Phone
+98 71 3725 1001
Email
zamanianz@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
mohammad nami
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Qasr al-Dasht Street;School of Advanced Medical Sciences and Technologies
City
Shiraz
Province
Fars
Postal code
novinmed@sums.ac.ir
Phone
+98 71 3234 0034
Email
novinmed@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
zahra zamanian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Ergonomics
Street address
Razi Blvd. School of Health
City
shiraz
Province
Fars
Postal code
071-37251001
Phone
+98 71 3725 1001
Email
zamanianz@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available