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

01 Feb 2019

The date of last modification

Aug 24, 2019



Application Summary


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)


Trial Details


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

  1. All the SLTB bus drivers who are working only as bus drivers on full time, permanent basis in buses commencing from their relevant depots in Colombo district
  2. Having scores above the cut off marks indicating occupational stress using the questionnaire – Effort-Reward Imbalance model. It has three subscales namely Effort, reward and overcommitmentThe cut off mark for occupational stress level will be calculated using following formula. Effort rewards Ratio = E/R XC. E=Sum of score of the effort scale.R= Sum of score of the reward scale. C=Is a correction factor=0.545. Values beyond 1.0 takes as occupational stress. Overcomittment considered separately as an association with this cutoff value.

Exclusion criteria

  1. Bus drivers who are engaged in temporary basis, emergency services and who are engaged in Luxury fleets.
  2. Bus drivers who have been diagnosed as suffering from mental illness.


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



State of Ethics Review Approval


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 & Sponsor Information


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)

Secondary study sponsor (If any)

None





Trial Completion details


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