Evaluating the impact of using the navigation system on driving performance by simulation
Design
Clinical trial with intervention and control group, two-way blind,
The sample size of 40 people will be used to randomize and create random sequences of Ralloc Module in STATA software. Allocation concealment will be by use of matte sealed envelopes will be done.
Settings and conduct
This study is performed in the traffic laboratory of Road Accident Prevention Research Center of Tabriz University of Medical Sciences. A video camera or eye tracker will be used to record a person's visual performance during the execution of scenarios. Also, in order to eliminate the study, Determine the existence of an interaction between the use of the navigation and ability for continuous attention and divided attention in relation to driving performance participants will be given tests of ability divided attention, Continuous performance test, reaction time by the Vienna test system.
Participants/Inclusion and exclusion criteria
The study population in this study is healthy drivers who have driver's license and have at least two years of driving experience.
Intervention groups
Participants randomly drive in groups A and B with the simulator. Group A will drive first with navigation (intervention) and then without navigation (control) with simulator, and group B will drive first without navigation and then with navigation.
Main outcome variables
Performance indicators of people driving with and without the use of navigation; reaction time to pedestrian crossing; lateral deviation; exceeding the speed limit
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201018049066N1
Registration date:2020-11-01, 1399/08/11
Registration timing:prospective
Last update:2020-11-01, 1399/08/11
Update count:0
Registration date
2020-11-01, 1399/08/11
Registrant information
Name
Esmat Saberi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6627 4605
Email address
esmat.saberi021@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-10, 1399/09/20
Expected recruitment end date
2021-03-10, 1399/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the impact of using the navigation system on driving performance by simulation
Public title
The impact of using the navigation system on driving performance by simulation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
No problem with uncorrected vision and color blindness
No simulator disease
Do not take Analgesic and sleeping pills the night before the test
No organ defects Volunteering to participate in the study
At least two years of driving experience
No Mental disease
Exclusion criteria:
Occurrence of any discomfort for the person during the study that prevents from continuing to cooperate or the person refuses to continue participating in the study for any reason.
Individual incompatibility with the simulator during preparation
Age
From 20 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
In this study, 40 participants randomly drive in two groups A and B with a simulator. Group A will drive first with a navigation and then without a navigation with a simulator, and group B will drive first without a navigation and then with a navigation. Participants in the distance between the two modes (with and without a router) to control the learning effect and fatigue. They will rest for 5 minutes. The Ralloc Module will be used in STATA software to randomize and create random sequences.Allocation Concealment coverage will be done using opaque numbered envelopes
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Azadi St., Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
کد پستی: 5165665931
Approval date
2020-09-07, 1399/06/17
Ethics committee reference number
IR.TBZMED.REC.1399.596
Health conditions studied
1
Description of health condition studied
Use the navigation system while driving
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Reaction time to cross the pedestrian
Timepoint
Measure once while using the Navigation and once without using the Navigation
Method of measurement
Driving simulator system
2
Description
lateral deviation
Timepoint
Measure once while using the Navigation and once without using the Navigation
Method of measurement
Driving simulator system
3
Description
Exceeding the speed limit
Timepoint
Measure once while using the Navigation and once without using the Navigation
Method of measurement
Driving simulator system
Secondary outcomes
empty
Intervention groups
1
Description
In order to determine the effect of using a router on driving performance, people randomly drive in groups A and B with a simulator. Group A They drive first with navigation(Intervention) and then without navigation(Control) with simulator, and group B first drives without navigation and then with navigation .Performance of people while driving in terms of variables of reaction time to events, lateral deviation, route navigation error and exceeding the speed limit will be recorded by the system.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Road Accident Prevention Research Center
Full name of responsible person
Dr. Homayoun Sadeghi Bazargani
Street address
Road Accident Prevention Research Center, Next to Shahran Tower, Towards the Flight, Golshahr Square, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5167846311
Phone
+98 41 3380 0568
Email
tiscsc@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hassan Aslani
Street address
Faculty of Health, Attar Neyshabouri St., Golgasht St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7581
Email
research-vice@tbzmed.ac.ir
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, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Esmat Saberi
Position
Master student in Health and Traffic
Latest degree
Bachelor
Other areas of specialty/work
Health and Traffic
Street address
Faculty of Health, Attar Neyshabouri St., Golgasht St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7582
Email
esmat.saberi021@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Yahya Rasoulzadeh
Position
Associate Professor of Occupational Health
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Health
Street address
Faculty of Health, Attar Neyshabouri St., Golgasht St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Email
rasoulzadehy@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Esmat Saberi
Position
MSc student in Health and Traffic
Latest degree
Bachelor
Other areas of specialty/work
Health and Traffic
Street address
Faculty of Health, Attar Neyshabouri St., Golgasht St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7581
Email
esmat.saberi021@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
This study is a master's thesis and its data is confidential.