Protocol summary

Study aim
Designing and evaluating the effect of educational intervention based on the PRECEDE-PROCEED model on anger management and safe driving performance of city taxi drivers
Design
A clinical trial with a control group, with parallel, one-blind, randomized groups, will be conducted on 117 urban taxi drivers in Dezful, Andimeshk, and Gotvand. Systematic random sampling will be used to select the samples.
Settings and conduct
The study will be performed in three phases before the intervention, immediately, and two months after the intervention in three groups (two case groups and one control group).
Participants/Inclusion and exclusion criteria
Employed in urban taxi driving job with a taxi driver registered in the taxi organization, Dezful, Andimeshk or Gotvand city, having at least one year of taxi driver experience, willingness to participate in the study, no mental illness affecting anger control
Intervention groups
Three groups of participants will include the traditional intervention group (distribution of pamphlets and holding training classes on case variables). The intervention group will be through the application (distribution of mobile application as an intervention method). Also in cyberspace, a weekly text message will be sent to both groups regarding the use of the application or reading the pamphlet. Training sessions include 6 sessions, each session will be 60 minutes, and the application information will be completely consistent with these sessions and their contents.
Main outcome variables
Ecological assessment variables (predisposing, enabling, and reinforcing factors), driving attitude, driving anger, driving behavior, driving performance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20111017007816N19
Registration date: 2022-05-11, 1401/02/21
Registration timing: registered_while_recruiting

Last update: 2022-05-11, 1401/02/21
Update count: 0
Registration date
2022-05-11, 1401/02/21
Registrant information
Name
Mahin Nazari
Name of organization / entity
School of health
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
manazari@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-06, 1400/12/15
Expected recruitment end date
2022-05-15, 1401/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing and evaluating the effect of educational intervention based on PRECEDE-PROCEED model on anger management and safe driving performance of city taxi drivers
Public title
Designing and evaluating the effect of educational intervention based on PRECEDE-PROCEED model on anger management and safe driving performance of city taxi drivers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being employed as a city driver with taxi driver code registered in the taxi organization of Dezful, Andimeshk or Gotvand city Have at least one year of taxi driver experience Willingness to participate in the study No mental illness affecting anger control
Exclusion criteria:
eing employed as a city driver with taxi driver code registered in the taxi organization of Dezful, Andimeshk or Gotvand city Have at least one year of taxi driver experience Willingness to participate in the study No mental illness affecting anger control
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 117
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, the mixed sampling method is used. As the cities of Dezful, Andimeshk and Gotvand are each considered as a cluster. Then, among the eligible people to enter the study in each city, 37 people in each group will be randomly selected and entered into the study. First, the list of qualified taxi drivers is obtained from the taxi organizations of each city. Then the first person is selected by simple random selection using a random table and other samples in each city based on the required sample size will continue in a systematic random sampling method until the required sample size is sampled. Obviously, the number of people in all three groups will be equal. In the final stage, two cities will be randomly selected as the case group, and the third group will be selected as the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Although in the stage of selecting cities for the case and control group, until the last moment, the researcher, selector of taxi codes, etc. was not aware of the case or control of the clusters, but in the intervention stages, due to the nature of training, blinding was practically impossible. But in the data analysis stage, blinding was done for the analyst. Also, at the stage of data collection by the evaluator, the evaluators were completely blinded and did not know in which group they were collecting data.
Placebo
Not used
Assignment
Parallel
Other design features
In this study, there are three groups and the evaluation of behavior is done by self-report by answering the questions of the questionnaire by the participants. Consistent with self-report responses, the evaluation of observed behavior (performance) is done by the evaluator in a direct and intangible way so that both the evaluator and the evaluated are unaware of the subject, but in the case of other variables, this blinding is practically impossible. .

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University Of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Province
Fars
Postal code
7153675541
Approval date
2020-02-02, 1398/11/13
Ethics committee reference number
IR.SUMS.REC.1398.1283

Health conditions studied

1

Description of health condition studied
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Ecological assessment (predisposing, enabling and strengthening factors)
Timepoint
Before, immediately and two months after the intervention
Method of measurement
Ecological assessment questionnaire

2

Description
Driving attitude
Timepoint
Before, immediately and two months after the intervention
Method of measurement
Driving Attitude Questionnaire

3

Description
Driving anger
Timepoint
Before, immediately and two months after the intervention
Method of measurement
Driving Anger Scale, Short Form (DAS)

4

Description
Driving behavior
Timepoint
Before, immediately and two months after the intervention
Method of measurement
Driving Behavior Questionnaire

5

Description
Driving performance
Timepoint
Before and two months after the intervention
Method of measurement
Wiener Fahrprobe technique= WF

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: Two intervention groups include: traditional intervention group (distribution of pamphlets and holding training classes) and training group through mobile application. Also in cyberspace, a weekly text message will be sent to both groups regarding the use of the application or reading the pamphlet.
Category
Behavior

2

Description
Control group: No intervention or training was provided for the control group.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Dezful Taxi Organization
Full name of responsible person
Mohammad Saffaripour
Street address
NO416- Bus Street-Post Street-dezful city
City
Dezful
Province
Khouzestan
Postal code
6461635519
Phone
+98 61 4242 0511
Email
dezful@imo.org.ir

2

Recruitment center
Name of recruitment center
Andimeshk Taxi Organization
Full name of responsible person
Mashallah Shakiba
Street address
NO 810-Andimeshk Passenger Terminal-Andimeshk Highway to Ahvaz - andimeshk city
City
andimeshk
Province
Khouzestan
Postal code
6481753781
Phone
+98 51 0426 4061
Email
andimashk@imo.org.ir

3

Recruitment center
Name of recruitment center
Gotvand Taxi Organization
Full name of responsible person
Ali Asadi
Street address
No 27- beside of ghaisar aminpour shine- Municipality Boulevard- Gotvand city
City
Gotvand
Province
Khouzestan
Postal code
6451653393
Phone
+98 61 3622 8310
Email
shahrdarigotvand@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahin Nazari
Street address
Razi St. 10 - Razi Boulevard - Zahra Alley - School of Health - Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1005
Email
manazari@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
Kumars Eisapareh
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Masoud Bakhtiari street-Ispareh village - Sardasht section - Dezful city
City
dezful
Province
Khouzestan
Postal code
6469113681
Phone
+98 61 4235 7335
Email
eqmars@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mahin Nazari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Razi St. 10 - Razi Boulevard - Zahra Alley - School of Health - Department of Health Promotion
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1005
Email
manazari@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Kumars Eisapareh
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Masoud Bakhtiari street- Ispareh village - Sardasht section - dezul city
City
dezful
Province
Khouzestan
Postal code
6469113681
Phone
+98 61 4235 7335
Email
eqmars@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
The total number of people referring to the magazine in which the article was published
Under which criteria data/document could be used
Supervisor
From where data/document is obtainable
Dr. Mahin Nazari Email manazari@sums.ac.ir
What processes are involved for a request to access data/document
The coordinators author takes about 1 week to 1 month
Comments
Loading...