Work-related IllnessNCT06484582
Investigation of Musculoskeletal System Disorders Seen in Automotive Industry Workers
An observational study of Work-related Illness and Work Injury, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the musculoskeletal disorders seen in automotive industry workers. Read more about this study
- Who is it for?
- Ages 25 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Work-related Illness, Work Injury
- What is being tested?
- workers
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jul 2024to 15 Oct 2024
- Phase
- Observational
- 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 25 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: auto industry workers
Who may be able to join
- Being between the ages of 25-60
- Not having any psychological or neurological disorders
- Being able to communicate in Turkish (written, verbal)
- Being able to communicate cognitively adequately
- Working full-time
- Being employed in an automotive industry for at least 5 years
Who cannot join
- Being under 18 or over 60
- Working part-time
- Being employed in the same business for less than 5 years
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Uskudar University
Istanbul
Ömer ŞEVGİN
About this study
The aim of this study is to examine the musculoskeletal disorders seen in automotive industry workers.
Read the detailed description
This study will be conducted as a face-to-face survey. Surveys will be created with Google Forms and will be filled out by the physiotherapist according to the participant's response.
- Conditions
- Work-related Illness, Work Injury
- Being tested
- workers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
workersOther
This study will be conducted as a face-to-face survey. Surveys will be created with Google Forms and will be filled out by the physiotherapist according to the participant's response.
What is being measured
The primary outcome is the main question the study is designed to answer.
Work Productivity & Activity Impairment Questionnaire - General Health
It is a tool developed to assess how health problems affect working life and daily activities in the general population. It measures the impact of health and symptom severity based on work productivity and leave time assessments and consists of 6 questions. These are; employment status, working hours, hours missed due to health problems, hours missed due to other reasons and the last two questions are the hours actually worked. It is scored from 0 to 10 points. The highest is 70, the lowest is 0. Higher scores indicate prolonged sick leave or impairment and reduced productivity.
Measured: 1 week
Pittsburgh Sleep Quality Survey
The scale includes a total of 24 questions. 19 of these questions are self-evaluation questions, and 5 of them are answered by the individual's spouse or a roommate. These 5 questions are used for clinical information only and are not included in the scoring. The scale questions that determine sleep quality include various factors related to sleep quality. These questions are to determine sleep duration, sleep latency, and the frequency and severity of specific sleep-related problems; 18 items were grouped as 7 component scores. The total score ranges from 0 to 21. A high total score indicates poor sleep quality. The scale does not indicate the presence of sleep disorders or the prevalence of sleep disorders. However, it is stated that a total score of 5 and above indicates poor sleep quality.
Measured: 1 week
Disabilities of the Arm, Shoulder and Hand Questionnaire
It was developed to evaluate functional status and symptoms by focusing on physical function in upper extremity injuries. According to the results of the survey; a result from 0-100 is obtained from each part; 0-no apology 100-maximum apology.
Measured: 1 week
Rapid Upper Limb Assessment
It is an ergonomics risk assessment method that quickly analyzes the employee's upper extremity from an ergonomic perspective. It evaluates upper extremity movements in 14 separate steps. 8 of these steps are scored for arm and hand position, and 6 for neck and trunk position, according to the table. The minimum Rapid Upper Limb Assessment Score = 1, and the maximum Rapid Upper Limb Assessment Score = 7. A high score means high risk.
Measured: 1 week
Nordic Extended Musculoskeletal Questionnaire
It is one of the questionnaires used to evaluate the severity and impact of musculoskeletal symptoms. In the survey, the frequency and severity of pain in the 'Neck, Shoulder, Upper Back, Elbow, Hand-wrist, Kala, Knee, Foot-ankle' areas of the body are evaluated in the last 12 months.It is a selection scale rather than a rating.
Measured: 1 week
The McGill Pain Questionnaire
McGill pain questionnaire-short form is used to evaluate patients' pain in terms of feeling and sensory. Pain level is defined with 15 words consisting of 11 sensory and 4 affective words. From these descriptive words, the patient should choose an answer that is compatible with him/her as "no (0)", "mild (1)", "moderate (2)", "severe (3)". In addition, the pain felt during the survey is measured with the Visual analog scale , and the total pain intensity of the pain is measured with a 6-point Likert scale. Pain is defined as "absent (0)" and "unbearable (5)" on the Likert scale. In total, pain scores between 0-45 (no pain=0, severe pain=45).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start19 Jul 2024
- Primary completion15 Oct 2024 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Work-related IllnessStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
- Investigators
- Sude Asya ALŞAN, Study chair, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484582
- Sponsor's protocol ID
- Uskudar13
- Status last verified
- Jul 2024
- First submitted
- 26 Jun 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eakin JM. Leaving it up to the workers: sociological perspective on the management of health and safety in small workplaces. Int J Health Serv. 1992;22(4):689-704. doi: 10.2190/DNV0-57VV-FJ7K-8KU5.
PubMed 1399176Govaerts R, Tassignon B, Ghillebert J, Serrien B, De Bock S, Ampe T, El Makrini I, Vanderborght B, Meeusen R, De Pauw K. Prevalence and incidence of work-related musculoskeletal disorders in secondary industries of 21st century Europe: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2021 Aug 31;22(1):751. doi: 10.1186/s12891-021-04615-9.
PubMed 34465326d'Errico A, Cardano M, Landriscina T, Marinacci C, Pasian S, Petrelli A, Costa G. Workplace stress and prescription of antidepressant medications: a prospective study on a sample of Italian workers. Int Arch Occup Environ Health. 2011 Apr;84(4):413-24. doi: 10.1007/s00420-010-0586-3. Epub 2010 Oct 16.
PubMed 20953623da Costa BR, Vieira ER. Risk factors for work-related musculoskeletal disorders: A systematic review of recent longitudinal studies. Am J Ind Med. 2010 Mar;53(3):285-323. doi: 10.1002/ajim.20750.
PubMed 19753591
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Musculoskeletal System Disorders Seen in Automotive Industry Workers
- ClinicalTrials.gov ID
- NCT06484582
- Acronym / sponsor ID
- Uskudar13
- Conditions
- Work-related Illness, Work Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 19 Jul 2024 (actual)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 3 Jul 2024 (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.
The aim of this study is to examine the musculoskeletal disorders seen in automotive industry workers.
Detailed description
This study will be conducted as a face-to-face survey. Surveys will be created with Google Forms and will be filled out by the physiotherapist according to the participant's response.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- auto industry workers
Key inclusion criteria (6 listed)
- Being between the ages of 25-60
- Not having any psychological or neurological disorders
- Being able to communicate in Turkish (written, verbal)
- Being able to communicate cognitively adequately
- Working full-time
Key exclusion criteria (3 listed)
- Being under 18 or over 60
- Working part-time
- Being employed in the same business for less than 5 years
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 |
|---|---|---|
| workersThis study will be conducted as a face-to-face survey. Surveys will be created with Google Forms and will be filled out by the physiotherapist according to the participant's response. | Other | – |
Primary outcome
Work Productivity & Activity Impairment Questionnaire - General Health
Time frame: 1 week
It is a tool developed to assess how health problems affect working life and daily activities in the general population. It measures the impact of health and symptom severity based on work productivity and leave time assessments and consists of 6 questions. These are; employment status, working hours, hours missed due to health problems, hours missed due to other reasons and the last two questions are the hours actually worked. It is scored from 0 to 10 points. The highest is 70, the lowest is 0. Higher scores indicate prolonged sick leave or impairment and reduced productivity.
Pittsburgh Sleep Quality Survey
Time frame: 1 week
The scale includes a total of 24 questions. 19 of these questions are self-evaluation questions, and 5 of them are answered by the individual's spouse or a roommate. These 5 questions are used for clinical information only and are not included in the scoring. The scale questions that determine sleep quality include various factors related to sleep quality. These questions are to determine sleep duration, sleep latency, and the frequency and severity of specific sleep-related problems; 18 items were grouped as 7 component scores. The total score ranges from 0 to 21. A high total score indicates poor sleep quality. The scale does not indicate the presence of sleep disorders or the prevalence of sleep disorders. However, it is stated that a total score of 5 and above indicates poor sleep quality.
Disabilities of the Arm, Shoulder and Hand Questionnaire
Time frame: 1 week
It was developed to evaluate functional status and symptoms by focusing on physical function in upper extremity injuries. According to the results of the survey; a result from 0-100 is obtained from each part; 0-no apology 100-maximum apology.
Rapid Upper Limb Assessment
Time frame: 1 week
It is an ergonomics risk assessment method that quickly analyzes the employee's upper extremity from an ergonomic perspective. It evaluates upper extremity movements in 14 separate steps. 8 of these steps are scored for arm and hand position, and 6 for neck and trunk position, according to the table. The minimum Rapid Upper Limb Assessment Score = 1, and the maximum Rapid Upper Limb Assessment Score = 7. A high score means high risk.
Nordic Extended Musculoskeletal Questionnaire
Time frame: 1 week
It is one of the questionnaires used to evaluate the severity and impact of musculoskeletal symptoms. In the survey, the frequency and severity of pain in the 'Neck, Shoulder, Upper Back, Elbow, Hand-wrist, Kala, Knee, Foot-ankle' areas of the body are evaluated in the last 12 months.It is a selection scale rather than a rating.
The McGill Pain Questionnaire
Time frame: 1 week
McGill pain questionnaire-short form is used to evaluate patients' pain in terms of feeling and sensory. Pain level is defined with 15 words consisting of 11 sensory and 4 affective words. From these descriptive words, the patient should choose an answer that is compatible with him/her as "no (0)", "mild (1)", "moderate (2)", "severe (3)". In addition, the pain felt during the survey is measured with the Visual analog scale , and the total pain intensity of the pain is measured with a 6-point Likert scale. Pain is defined as "absent (0)" and "unbearable (5)" on the Likert scale. In total, pain scores between 0-45 (no pain=0, severe pain=45).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Background: PubMed 1399176Eakin JM. Leaving it up to the workers: sociological perspective on the management of health and safety in small workplaces. Int J Health Serv. 1992;22(4):689-704. doi: 10.2190/DNV0-57VV-FJ7K-8KU5.
- Background: PubMed 34465326Govaerts R, Tassignon B, Ghillebert J, Serrien B, De Bock S, Ampe T, El Makrini I, Vanderborght B, Meeusen R, De Pauw K. Prevalence and incidence of work-related musculoskeletal disorders in secondary industries of 21st century Europe: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2021 Aug 31;22(1):751. doi: 10.1186/s12891-021-04615-9.
- Background: PubMed 20953623d'Errico A, Cardano M, Landriscina T, Marinacci C, Pasian S, Petrelli A, Costa G. Workplace stress and prescription of antidepressant medications: a prospective study on a sample of Italian workers. Int Arch Occup Environ Health. 2011 Apr;84(4):413-24. doi: 10.1007/s00420-010-0586-3. Epub 2010 Oct 16.
- Background: PubMed 19753591da Costa BR, Vieira ER. Risk factors for work-related musculoskeletal disorders: A systematic review of recent longitudinal studies. Am J Ind Med. 2010 Mar;53(3):285-323. doi: 10.1002/ajim.20750.
- Individual participant dataSharing planned: No
Related trials for Work-related Illness
Recruiting
Acceptability and Feasibility of Work-Oriented Social-Cognitive Skills Training for Veterans With Serious Mental Illness
Schizophrenia, Bipolar Disorder
Recruiting
Working in the Heat at Simulated Altitude: Effects of Normobaric Hypoxia on Physiological Strain
Body Temperature Changes, Heat Stress
Active, not recruiting
A Multicentre Randomised Controlled Trial of the Norwegian Health in Work Service. The NSAC Efficacy Study
Musculoskeletal Disorder, Anxiety Disorders
Active, not recruiting
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
Musculoskeletal Disorder, Anxiety Disorders
Active, not recruitingObservational study
Comparison of Three Treatment Strategies for Traumatic AO Type A1 Vertebral Fractures
Traumatic Vertebral Fractures, Compression Fractures of the Spine
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.
Sude Asya ALŞAN study chair
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Work-related Illness and Work Injury, run by Uskudar University at 1 site in Turkey (Türkiye).
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 3 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: status not confirmed, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ömer ŞEVGİN (+905069787535, omer.sevgin@uskudar.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work Productivity & Activity Impairment Questionnaire - General Health (time frame: 1 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06484582, which also lists 4 linked publications.
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 22 Jul 2024.