Home » Trials » SLCTR/2019/005
Prevalence and associated factors of occupational stress and the effectiveness of an intervention to manage it among bus drivers of Sri Lanka Transport Board in Colombo district
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SLCTR Registration Number
SLCTR/2019/005
Date of Registration
The date of last modification
Sep 16, 2020
Scientific Title of Trial
Prevalence and associated factors of occupational stress and the effectiveness of an intervention to manage it among bus drivers of Sri Lanka Transport Board in Colombo district
Public Title of Trial
Study on the usefulness of a stress management program to reduce occupation related stress among bus drivers working at the Sri Lanka Transport Board in Colombo district, Sri Lanka
Disease or Health Condition(s) Studied
Occupational health
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1226-6507
Any other number(s) assigned to the trial and issuing authority
Approved by Ethics Review Committee, Faculty of Medicine, University of Colombo on 18th October 2018 (Ref. No:EC-18-098)
What is the research question being addressed?
Could an intervention addressing occupation stress reduce stress among bus drivers of the Sri Lanka Transport Board in the Colombo district?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Active
Assignment
Parallel
Purpose
Other
Study Phase
Not Applicable
Intervention(s) planned
Study setting – All the SLTB depots in Colombo district. Each depot will be considered as a cluster. 6 depots will receive the intervention while other 6 will remain as control. Depots (clusters) will be selected to each arm by simple randomization.
Intervention: Drivers in the intervention group will be divided into 2 groups. Both group 1 and 2 will consist of 36 drivers. The intervention consists of 6 modules. The first 4 modules are based on concepts of emotional intelligence namely self awareness, self management, community awareness and community management. (It covers the health promotion action area-empowerment and skill development.) Last two modules cover the action areas of health promotion namely supportive environment and sustainability. Each activity session lasts for 2-4 hours and will be conducted once per week for both groups during the 1st,2nd,3rd,5th and 6th month. The 4th month will be free of activities, which will enable them to practice what they learnt and put it into action. It allows them to verify doubts and share experience in the 5th and 6th months. In the last month, a talent show and reassessment of the primary and secondary outcomes will be measured by the respective questionnaires. Activities will be conducted by the principal investigator, a consultant psychiatrist, psychologist and a counselor, a sociologist, and a meditation practitioner from a Buddhist organization.
Bus drivers in the control group will be the active control. Only the participants will be blinded.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
the level of occupational stress, pre and post intervention. The level of stress will be measured using the tool ‘Effort-Reward Imbalance model’. |
[ 6 months after the commencement of the intervention ] |
Secondary outcome(s)
|
1.
Engaged in road rage perpetration activities more than monthly over the last 3 months would be considered positive for perpetration of road rage. Road rage will be assessed using the road rage questionnaire. |
[ 6 months after the start of the intervention ] |
Target number/sample size
72 participants for each study group and control group
Countries of recruitment
Sri Lanka
Anticipated start date
2019-03-01
Anticipated end date
2019-09-02
Date of first enrollment
2019-05-14
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2018-10-18
Approval number
EC-18-098
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
D.K.Illangasinghe
Registrar in Community Medicine
Health Promotion Bureau, No2, Kynsey Road,Colombo 08
011-2696606
077-4043460
011-2692613 (Office)
dhananjachami@gmail.com
www.healthedu.gov.lk (Office)
Contact Person for Public Queries
M.A.A.P Alagiyawanna
Consultant Community Physician
Health Promotion Bureau,
No2, Kynsey Road,
Colombo 08
011-2692613
ajithalagie@yahoo.com
Primary study sponsor/organization
Health Promotion Bureau
No2, Kynsey Road,Colombo 08
011-2696606
011-2692613 (Office)
dhananjachami@gmail.com
www.healthedu.gov.lk (Office)
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
Individual participant data that underlie the results will be shared after the de-identification (tables,figures,appendices). This will be immediately following publication (no end date). Data sharing will be with investigators whose proposed use of the data has been approved by an independent review committee/ethical review committee identified for this purpose, to achieve the aims of the approved proposal. Proposals should be directed to dhananjachami@gmail.com and ajithalagie@yahoo.com
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
