Occupational ExposureErgonomicsNCT03926871
Ergonomics Training Program to Industrial Workers
A study testing Ergonomic Training in people with Occupational Exposure, run by Rosimeire Simprini Padula.
Trial summary
This quasi-experimental study was performed in poultry processing industry. The study aimed to evaluate the benefits of ergonomic training for novice and experienced workers. Sociodemographic and occupational questionnaires were evaluated, musculoskeletal complaints and pain intensity, perceived occupational effort… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occupational Exposure
- What is being tested?
- Ergonomic Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2014to 20 Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- For all workers
- Had already received ergonomic training (general guidelines and postural adjustments)
- Pregnant women
- People with disabilities.
About this study
Official title: Ergonomics Training Program to Novice and Experienced Workers in Poultry Processing Industry: A Quasi-experimental Study
This quasi-experimental study was performed in poultry processing industry. The study aimed to evaluate the benefits of ergonomic training for novice and experienced workers. Sociodemographic and occupational questionnaires were evaluated, musculoskeletal complaints and pain intensity, perceived occupational effort, biomechanical exposure and perception in adopting the training. Complaints in the cervical, wrist and lumbar region were reduced with training, but the intensity of pain was only reduced in the wrist region. There was a reduction in the occupational biomechanical exposure from pre-training, to the post-immediate, and from pre-training to after 2 months for both beginners and experienced. The group of novice workers differed from those with the highest biomechanical exposure reduction in the cutting room tasks. All workers were benefited by ergonomic training in the short and medium term.
Read the 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.
- Conditions
- Occupational Exposure
- Being tested
- Ergonomic Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergonomic TrainingOther
Also called Postural and Occupational (tasks) training
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.
| Study group | Role | What they receive |
|---|---|---|
| Novices | Experimental | 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. Receives: Other: Ergonomic Training |
| Experienced | Experimental | 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. Receives: Other: Ergonomic Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Musculoskeletal Complains at 2 months
The Nordic Musculoskeletal Questionnaire was used to investigate the presence of musculoskeletal symptoms in the last month with dichotomous responses (yes or no)
Measured: baseline, after two months
Change from Pain Intensity at 2 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).
Measured: baseline, after two months
Change from Biomechanical Exposure immediately after the interventional training and 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).
Measured: baseline, after 1-2 days, after two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start20 Aug 2014
- Primary completion17 Dec 2014
- Study completion20 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two independents groups (Novice and Experienced). Both groups received ergonomics training in workplace.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rosimeire Simprini Padula
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rosimeire Simprini Padula, Universidade Cidade de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926871
- Sponsor's protocol ID
- 734.500
- Acronym
- Ergonomics
- Status last verified
- Apr 2019
- First submitted
- 16 Apr 2019
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ergonomics Training Program to Novice and Experienced Workers in Poultry Processing Industry: A Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT03926871
- Acronym / sponsor ID
- Ergonomics / 734.500
- Conditions
- Occupational Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Rosimeire Simprini PadulaUniversity, hospital or other
- Study start
- 20 Aug 2014 (actual)
- Primary completion
- 17 Dec 2014 (actual)
- Study completion
- 20 Feb 2015 (actual)
- First posted
- 25 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This quasi-experimental study was performed in poultry processing industry. The study aimed to evaluate the benefits of ergonomic training for novice and experienced workers. Sociodemographic and occupational questionnaires were evaluated, musculoskeletal complaints and pain intensity, perceived occupational effort, biomechanical exposure and perception in adopting the training. Complaints in the cervical, wrist and lumbar region were reduced with training, but the intensity of pain was only reduced in the wrist region. There was a reduction in the occupational biomechanical exposure from pre-training, to the post-immediate, and from pre-training to after 2 months for both beginners and experienced. The group of novice workers differed from those with the highest biomechanical exposure reduction in the cutting room tasks. All workers were benefited by ergonomic training in the short and medium term.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two independents groups (Novice and Experienced). Both groups received ergonomics training in workplace.
| Arm | Type | Receives |
|---|---|---|
| Novices | Experimental | Other: Ergonomic TrainingThey 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. |
| Experienced | Experimental | Other: Ergonomic TrainingThey 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- For all workers
- Had already received ergonomic training (general guidelines and postural adjustments)
- Pregnant women
- People with disabilities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ergonomic TrainingAlso: Postural and Occupational (tasks) trainingThe 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 | Experienced, Novices |
Primary outcome
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)
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ergonomic Training in people with Occupational Exposure, run by Rosimeire Simprini Padula.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Musculoskeletal Complains at 2 months (time frame: baseline, after two months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2019.