- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03926871
Ergonomics Training Program to Industrial Workers (Ergonomics)
Ergonomics Training Program to Novice and Experienced Workers in Poultry Processing Industry: A Quasi-experimental Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The research was submitted to the Local Research Ethics Committee and approved by the number 734.500.
Were included 51 employees from the packing and cutting room sectors. The workers were allocated to Novato and Experienced workers groups. The inclusion criteria for the Novato workers group were to be newly hired (1 to 2 days in the company) and not have previous experience in a poultry processing industry, or butcher's shop. It is to ensure that they did not have prior knowledge of the activity. In the case of the group of experienced workers.
The exclusion criteria were they worked on the task for more than six months and not be absent during the study period (scheduled vacations). Workers who had already received ergonomic training, such as general guidelines and postural adjustments, as well as pregnant women and people with disabilities were excluded.
Outcomes measure
- Musculoskeletal Complains and Pain Intensity The Nordic Musculoskeletal Questionnaire was used to investigate the presence of musculoskeletal symptoms in the last month, using dichotomous responses (yes or no) The visual analogue pain scale evaluated the intensity of symptoms indicating "absence of pain" (0) on one side and the opposite side "unbearable pain" (10 cm) (Carlsson 1982). The QNSO and pain scale were applied in both groups at the baseline, and after 2 months of the ergonomic training program.
Biomechanical Exposure Analysis The analysis of occupational biomechanical exposure occurred through a Poultry processing Check list (PPChecklist) created for the study. The PPChecklist evaluation criteria were based on observational methods for biomechanical exposure analysis, such as the Rapid Upper Limb Assessment (RULA) and Strain Index and the Checklist for Musculoskeletal Risk Assessment (RARME).
The analyzes of the video tasks of each worker for the application of the PPChecklist was performed by two independent evaluators (MSD and DPV) with experience in Worker's Health and Ergonomics. The results obtained with the analysis of the biomechanical exposure of each segment (cervical, shoulder, forearm, wrist, hand and spine) were added to obtain a general task risk score for each worker with a variation of the score between 0 -19 points. The higher the score, the greater the biomechanical exposure of the workers.
- Perceived effort and Training Perception The effort perceived by workers in pre-training was evaluated by Borg scale ranges from zero (rest / effortless perceived) to ten (very, very heavy / too much, too much effort).
To evaluate the self-perception of the ease / difficulty of following the training guidelines was created a questionnaire.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
To Novato workers
- 1 to 2 days in the company
- Not have previous experience in a frigorifico, or butcher's shop
- Not have prior knowledge of the activity. To experienced workers
- Work on the task for more than six months
- Be present in company during the study period
Exclusion Criteria:
For all workers
- Had already received ergonomic training (general guidelines and postural adjustments)
- Pregnant women
- People with disabilities.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Novices
They received ergonomic training after 1-2 days of hiring to do the work in the cutting room, and packaging sectors.
They did not have experience in the refrigerator or butchers, so they had the minimum of information about tasks and risks.
|
The ergonomic training consisted of an educational program in Ergonomics with a duration of 60 (sixty) minutes divided into a theoretical exposition and videos of the occupational tasks performed by the workers themselves.
Theoretical lecture covered topics such as ergonomics, human anatomy, worker health, prevention measures to minimize the risks of musculoskeletal diseases.
A better way of performing the work to protect the musculoskeletal system was demonstrated.
Other Names:
|
|
Experimental: Experienced
They received the same ergonomic training as the newbies, and should have been hired for more than 6 months in the company.
In this period they had already acquired patterns of movement and self-protection to accomplish the tasks.
|
The ergonomic training consisted of an educational program in Ergonomics with a duration of 60 (sixty) minutes divided into a theoretical exposition and videos of the occupational tasks performed by the workers themselves.
Theoretical lecture covered topics such as ergonomics, human anatomy, worker health, prevention measures to minimize the risks of musculoskeletal diseases.
A better way of performing the work to protect the musculoskeletal system was demonstrated.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Musculoskeletal Complains at 2 months
Time Frame: baseline, after two months
|
The Nordic Musculoskeletal Questionnaire was used to investigate the presence of musculoskeletal symptoms in the last month with dichotomous responses (yes or no)
|
baseline, after two months
|
|
Change from Pain Intensity at 2 months
Time Frame: baseline, after two months
|
The visual analogue pain scale evaluated the intensity of symptoms indicating "absence of pain" (0) on one side and the opposite side "unbearable pain" (10 cm).
|
baseline, after two months
|
|
Change from Biomechanical Exposure immediately after the interventional training and after two months
Time Frame: baseline, after 1-2 days, after two months
|
Analysis of the biomechanical exposure of each segment (cervical, shoulder, forearm, wrist, hand and spine) by by an observational method developed for the study with score (0-19 points).
|
baseline, after 1-2 days, after two months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 734.500
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Occupational Exposure
-
Oslo University HospitalCompleted
-
Ohio State UniversityUniversity of Kansas Medical CenterCompletedOccupational ExposureUnited States
-
University of VirginiaCompletedOccupational ExposureUnited States
-
Cairo UniversityUnknown
-
Avinashilingam Deemed UniversityIndian Council of Medical ResearchUnknownOccupational ExposureIndia
-
University of PrimorskaRecruiting
-
Swiss Federal Institute of TechnologyAuxivo AGCompletedOccupational ExposureSwitzerland
-
Ege UniversityCompleted
-
Assiut UniversityUnknown
-
Istituti Clinici Scientifici Maugeri SpACompleted
Clinical Trials on Ergonomic Training
-
Kutahya Health Sciences UniversityNot yet recruitingPain | Sleep | Anxiety StateTurkey (Türkiye)
-
Jer-Hao ChangCompletedMusculoskeletal DisordersTaiwan
-
National Research Centre for the Working Environment...CompletedMusculoskeletal DisordersDenmark
-
Universiti Putra MalaysiaCompletedLow Back Pain | Musculoskeletal Pain
-
Forschungsinstitut für Balneologie und Kurortwissenschaft...European Union; Federal ministry of labour and social affairsCompleted
-
Foundation University IslamabadRecruiting
-
Virginia Commonwealth UniversityCompletedOccupational InjuriesUnited States
-
University of Nevada, Las VegasRecruitingNo Disease or Condition is Being StudiedUnited States
-
Danish Headache CenterCompletedTension-Type HeadacheDenmark
-
Istanbul University - CerrahpasaCompletedPrimary School Children | Musculoskeletal SymptomTurkey (Türkiye)