Assessment of preventive behaviors, assessment of pain, and assessment of disability caused by musculoskeletal disorders.
Design
The clinical trial has a randomized control group, the study will be conducted on 116 participants, and a sealed bag will be used for randomization.
Settings and conduct
The study will be conducted in Petrochemical Company of Asalouye city and the training will be provided in the form of face-to-face training by the researcher in the form of lectures, pamphlets, posters, and webinars to the intervention group.
Blinding was not used in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Willingness to participate in research
Internet access
Work experience of more than two years
Exclusion criteria:
Having a second job
Musculoskeletal disorders due to pathological causes
Medical prohibition to exercise
Intervention groups
In this study, 58 participants will be part of the intervention group and 58 participants will be part of the control group. During the study, the intervention group will receive an educational intervention program, but the control group will not receive any educational program.
Main outcome variables
Prevention of musculoskeletal disorders related to work, pain, disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240321061346N1
Registration date:2024-04-10, 1403/01/22
Registration timing:prospective
Last update:2024-04-10, 1403/01/22
Update count:0
Registration date
2024-04-10, 1403/01/22
Registrant information
Name
Zohreh Moradi
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 918 568 7572
Email address
zohre_moradi@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-20, 1403/02/31
Expected recruitment end date
2024-06-20, 1403/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of the educational intervention program in the prevention of musculoskeletal disorders
Public title
Investigating the effect of intervention on musculoskeletal disorders
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Employees who want to participate in research.
Employees who have access to the Internet and the ability to use mobile phones.
Employees who have more than two years of experience in the petrochemical industry.
Exclusion criteria:
Having a second job.
People who do not have musculoskeletal disorders caused by work.
Having any musculoskeletal disorders with a pathological cause.
Having any diseases or problems that prevent a person from participating in studying and doing sports exercises.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization method with individual randomization unit and random number table method (even numbers for the intervention group and odd numbers for the control group) will be used and sealed envelope.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tarbiat Modares University
Street address
Jalal Al Ahmad Highway, Nasr Bridge, Tarbiat Modares University, Faculty of Medical Sciences, Department of Health Education and Health Promotion.
City
Tehran
Province
Tehran
Postal code
1411613117
Approval date
2024-03-11, 1402/12/21
Ethics committee reference number
IR.MODARES.REC.1402.251
Health conditions studied
1
Description of health condition studied
Musculoskeletal Disorders
ICD-10 code
M95.8
ICD-10 code description
Other specified acquired deformities of musculoskeletal system
Primary outcomes
1
Description
1. Work-related musculoskeletal disorders
Timepoint
Before the intervention, immediately after the intervention, three months after the intervention and six months after the intervention
Method of measurement
Nordic questionnaire and researcher-made questionnaire
Secondary outcomes
1
Description
Pain caused by musculoskeletal disorders
Timepoint
Before the intervention, immediately after the intervention, three months after the intervention and six months after the intervention
Method of measurement
Visual analog scale
2
Description
Disability caused by pain
Timepoint
Before the intervention, immediately after the intervention, three months after the intervention and six months after the intervention
Method of measurement
Quebec Pain Disability Scale
Intervention groups
1
Description
The intervention group of educational packages includes a speech by an expert in health education and health promotion, an expert in occupational health and ergonomics, a presentation of pamphlets and posters, educational clips about musculoskeletal problems and disorders, appropriate behaviors to maintain proper postures during work and They will receive daily activities, improvement of working environment conditions, stretching exercises and stress control methods, for one month, twice a week and each session lasts 40 minutes.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Tarbiat Modares University
Full name of responsible person
Segidheh SadatTavafian
Street address
Jalal Al Ahmad Highway, Nasr Bridge, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 912 287 6439
Email
tavafian@modares.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Sedigheh Sadat Tavafian
Street address
Jalal Al Ahmad Highway, Nasr Bridge, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 912 287 6439
Email
tavafian@modares.ac.ir
Grant name
Tarbiat Modares University
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
Tarbiat Modares University
Full name of responsible person
Zohreh Moradi
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Jalal Al Ahmad Highway, Nasr Bridge, Department of Health Education and Health Promotion, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 918 568 7572
Email
zohre_moradi@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Sedigheh Sadat Tavafian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Jalal Al Ahmad Highway, Nasr Bridge, Department of Health Education and Health Promotion, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 912 287 6439
Email
tavafian@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Sedigheh Sadat Tavafian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Jalal Al Ahmad Highway, Nasr Bridge, Department of Health Education and Health Promotion, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 912 287 6439
Email
tavafian@modares.ac.ir
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
After the end of the study, the data obtained from the participants will be available in a de-identified form. Also, the informed consent form, the codes used in the analysis, the study protocol, the statistical analysis map, the clinical report of the study, and the data dictionary will be available if needed.
When the data will become available and for how long
The access period will start 6 months after the publication of the results.
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions, and people working in industry can apply to receive them.
Under which criteria data/document could be used
Any analysis of the data taken by others is not allowed and only individuals can use the data to conduct similar studies.
What processes are involved for a request to access data/document
The requester must send an email to the main researcher or supervisor to obtain the data file, and the data will be sent to the requester within a week to ten days, if necessary.