Protocol summary

Summary
The aim of this study was to evaluate the effectiveness of individual-focused Progressive Muscle Relaxation as part of a Worksite Health Promotion Program on self-perceived occupational stress among male automotive assembly-line workers.A quasi-experimental study was conducted in two automotive assembly plants in Malaysia over 9 months. One of the assembly plant received Progressive Muscle Relaxation training while other acted as a control by receiving pamphlets on stress and its ill-effects. Intention-to-treat analysis was conducted to test the effectiveness of the relaxation therapy. The level of stress was measured using Stress subscale of Depression Anxiety Stress Scales-21.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014021516578N1
Registration date: 2014-02-28, 1392/12/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-02-28, 1392/12/09
Registrant information
Name
Bala Sundram
Name of organization / entity
University Malaya
Country
Malaysia
Phone
+60 (3) 7967 4756
Email address
balamurali@siswa.um.edu.my
Recruitment status
Recruitment complete
Funding source
Self-funded
Expected recruitment start date
2012-01-20, 1390/10/30
Expected recruitment end date
2012-09-30, 1391/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Progressive Muscle Relaxation as part of a Worksite Health Promotion Program to Alleviate Stress in the Automotive Assembly Line: A Quasi Experimental Study.
Public title
Effects of Progressive Muscle Relaxation as part of a Worksite Health Promotion Program to Alleviate Stress in the Automotive Assembly Line.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria were all male workers directly attached to the production line and who had been working at the site for more than 1 year. Respondents with psychiatric illnesses with or without medication, having prior training or current use of relaxation therapy, working less than 1 year and respondents without consent were excluded.
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 176
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
WHO Universal Trial Number(UTN)
Secondary trial Id
U1111-1153-4963
Registration date
2014-02-18, 1392/11/29

Ethics committees

1

Ethics committee
Name of ethics committee
Medical Ethics Committee, University Malaya Medical Centre
Street address
Lembah Pantai,
City
Kuala Lumpur
Postal code
59100
Approval date
2012-01-18, 1390/10/28
Ethics committee reference number
895.11

Health conditions studied

1

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

Primary outcomes

1

Description
Stress
Timepoint
2 monthly interval for 9 months from baseline
Method of measurement
Depression,Anxiety, Stress Scale (DASS-21)

Secondary outcomes

empty

Intervention groups

1

Description
Plant B as the pamphlet group acting as control.
Category
Treatment - Other

2

Description
The study was conducted in the state of Selangor, Malaysia at a place called Rawang, from the district of Hulu Selangor. Plant A was selected as the intervention group for the combined Progressive Muscle Relaxation (PMR) therapy .The study in both groups commenced in January 2012 and assessed with the shortened and self-administered Depression, Anxiety and Stress Scale (DASS-21) questionnaire. The reinforcement sessions were done from baseline at 2 monthly intervals till 9th month in the PMR group. The control group received pamphlet distribution on stress, at baseline and end of 9th month. The sample for the study were voluntary individuals willing to participate, taken from the study population whom were screened by the short, self-administered and validated Malay version of Depression, Anxiety and Stress Scale (DASS-21) questionnaire.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Perusahaan Otomobil Kedua Sdn Bhd Sungai Choh, Locked Bag 226, 48009 Rawang, Selangor Darul Ehsan, M
Full name of responsible person
Street address
City
Rawang

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bala Murali Sundram
Full name of responsible person
Bala Murali Sundram
Street address
Department of Social and Preventive Medicine, Faculty of Medicine Building, University of Malaya
City
Kuala Lumpur
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bala Murali Sundram
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
University of Malaya
Full name of responsible person
Bala Murali Sundram
Position
Doctorate student/MBBS, MPH
Other areas of specialty/work
Street address
Department of Social and Preventive Medicine, Faculty of Medicine Building, University of Malaya
City
Kuala Lumpur
Province
Kuala Lumpur
Postal code
50603
Phone
00637967 4928
Fax
Email
balamurali@siswa.um.edu.my
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Malaya
Full name of responsible person
Maznah Dahlui
Position
Associate Professor/ MBBS, MPH
Other areas of specialty/work
Street address
Department of Social and Preventive Medicine, Faculty of Medicine Building, University of Malaya
City
Kuala Lumpur
Province
Kuala Lumpur
Postal code
Phone
00637967 4756
Fax
Email
maznahd@um.edu.my
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University Malaya
Full name of responsible person
Bala Murali
Position
Doctorate student/MBBS, MPH
Other areas of specialty/work
Street address
Department of Social and Preventive Medicine, Faculty of Medicine Building, University of Malaya
City
Kuala Lumpur
Province
Kuala Lumpur
Postal code
50603
Phone
006037967 4756
Fax
Email
balamurali@siswa.um.edu.my
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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