UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039493 |
|---|---|
| Receipt number | R000045018 |
| Scientific Title | The effect of psychological and social interventions on risky driving:A clinical trial study by using simulated and real driving |
| Date of disclosure of the study information | 2020/02/15 |
| Last modified on | 2023/08/19 21:45:14 |
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Basic information
Public title
En The effect of psychological and social interventions on risky driving
Acronym
P&SIORD
Scientific Title
The effect of psychological and social interventions on risky driving:A clinical trial study by using simulated and real driving
Scientific Title:Acronym
P&SIORD
Region
| Asia(except Japan) |
Condition
Condition
Risky driving
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Determination of the effect of psychological and social interventions on risky driving of drivers
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1- Driving offences recorded by the traffic police 6 months and one year after intervention
Key secondary outcomes
1-Driving offense score while driving with a simulator before and 2 weeks after intervention
2-Driving anger before and 2 weeks after intervention
3-Driving anger expressing before and 2 weeks after intervention
4-Anger status before and 2 weeks after intervention
5-Driving behavior before intervention and 2 weeks after intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention1:Mind fullness; 6-8 sessions by psychologist during 3-4 weeks
Interventions/Control_2
Intervention2: Meta cognition;6 sessions by psychologist during 3 weeks
Interventions/Control_3
Intervention 3: Social marketing ;A four-hour program prepared by a social medicine specialist
Interventions/Control_4
Interventions/Control_5
control:Wait list control group
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 19 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The 19-60 years old drivers who have driving license and their license has been seized by the traffic police for driving violations are participants of this study.
Key exclusion criteria
If participants had a specific illness that affects the results of the study, they will not be included in the study.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Farideh |
| Middle name | |
| Last name | Sadeghian |
Organization
Shahroud University of Medical sciences
Division name
Center for Health Related Social and Behavioral Sciences Research
Zip code
36147-73947
Address
Haftetir Square, Shahroud University of Medical Sciences, Shahroud, IRAN
TEL
+98-23-32394091
farsadeghian@shmu.ac.ir
Public contact
Name of contact person
| 1st name | Farideh |
| Middle name | |
| Last name | Sadeghian |
Organization
Shahroud University of Medical sciences
Division name
farsadeghian@shmu.ac.ir
Zip code
36147-73947
Address
Haftetir Square, Shahroud University of Medical Sciences, Shahroud, IRAN
TEL
+98-23-32394091
Homepage URL
http://shmu.ac.ir/fa
info@shmu.ac.ir
Sponsor or person
Institute
Shahroud University of Medical Sciences
Center for Health Related Social and Behavioral Sciences Research
Institute
Department
Personal name
Funding Source
Organization
Shahroud University of Medical Sciences
Center for Health Related Social and Behavioral Sciences Research
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Iranian
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shahroud University of Medical Sciences-Center for Health Related Social and Behavioral Sciences Research
Address
Haftetir Square, Shahroud University of Medical Sciences, Center for Health Related Social and Behavioral Sciences Research,Shahroud, IRAN
Tel
+98-23-32394091
info@shmu.ac.ir
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
"Shahroud University of Medical Sciences","Center for Health Related Social and Behavioral Sciences Research"
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
http://ris.shmu.ac.ir/main/cartable.action#
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
232
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Covid-19 pandemic and lock-down and social distance
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 06 | Month | 07 | Day |
Date analysis concluded
| 2022 | Year | 10 | Month | 30 | Day |
Other
Other related information
Outcomes:
1-Driving offenses record by the traffic police
2-Driving offense score while driving with a simulator recorded by simulator
3-Driving anger,driving anger expression,Anger and driving behavior measured by valid questionnaire.
Management information
Registered date
| 2020 | Year | 02 | Month | 15 | Day |
Last modified on
| 2023 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045018
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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