Work-related Musculoskeletal System Disorders Among Female Workers in Hazelnut Factory

March 10, 2019 updated by: Sevim ACARÖZ CANDAN, T.C. ORDU ÜNİVERSİTESİ

Work-related Musculoskeletal Disorders Among Female Workers in a Hazelnut Factory: Prevalence, Working Posture and Relating Factors

The aim of this study is to determine the prevalence of work-related musculoskeletal disorders in female workers in hazelnut factory. The secondary aim is to investigate the relationship between the musculoskeletal disorders severity and working posture, work related factor, psychosocial factor.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
114

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Altinordu
      • Ordu, Altinordu, Turkey, 52100
        • Sevim ACARÖZ CANDAN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The population of this study involved the female workers of a hazelnut factory.

Description

Inclusion Criteria:

  • age >18 years,
  • had at least 12 months of continuous working experience in hazelnut selection.

Exclusion Criteria:

  • having pregnancy,
  • working in a standing position or having a burden job,
  • having joint disease, gout, diabetes, and trauma during the last one year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Nordic Musculoskeletal Questionnaire (NMQ)
Time Frame: 10 minutes
NMQ will be used to determine the self-reported musculoskeletal symptoms in the different body part (neck, shoulder, elbow, wrist, upper back, lower back, hip, knee, ankle) in which suffered from aches, pain, or discomfort during the last 12 months. The states of the obtained sick leave from work, obstructing of work, taken medication and seen a doctor or physiotherapist etc. during the past 12 months regarding the work-related MSD will be questioned. The participants can be responded by "yes" or "no".
10 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dutch Musculoskeletal Questionnaire short version (DMQ-s)
Time Frame: 10 minutes
DMQ-s was used to evaluate the perceived workload, work-related risk factors, and general health status. DMQ-s involves four sections (general question, health, perceived workload, ergonomic environment). The score of the three sections except the general questions section will be summed. Higher scores means risky situation for work-related musculoskeletal disorders.
10 minutes
Assessment of the working posture
Time Frame: 2 minutes
The working posture will be assessed using the photogrammetry method which is a reliable and valid tool for postural angles analysis. The photographs were taken the lateral aspect of the workers using a digital, professional camera (Canon 4000D, Japan) from a 150cm distance, at the height of the acromion in working position. Cranio-vertebral angle (CVA), thoracic kyphosis and lumbar lordosis angles were measured on the photograph using the ImageJ program. The results will be recorded as degree.
2 minutes
Rapid Upper Extremity Assessment
Time Frame: 5 minutes
Rapid Upper Limb Assessment (RULA) is a tool to evaluate upper extremity MSD risk factors. The RULA ergonomic assessment tool considers biomechanical and postural load requirements of job tasks/demands on the neck, trunk and upper extremities. A single page worksheet is used to evaluate required body posture, force, and repetition. Based on the evaluations, scores are entered for each body region in section A for the arm and wrist, and section B for the neck and trunk. After the data for each region is collected and scored, tables on the form are then used to compile the risk factor variables, generating a single score that represents the level of MSD risk. The score means 1-2 negligible risk no change requirement, 3-4 low risk change may be needed requirement, 5-6 medium risk further investigation change soon, 6+ very high risk implement change now
5 minutes
Short Form-12 Health Survey (SF-12 Health Survey)
Time Frame: 5 minutes
SF-12 Health Survey is a multidimensional generic measure of health-related quality of life. SF-12 Health Survey includes two subdomains as physical and mental. SF-12 Health Survey has a scoring algorithm. The higher scores defines good quality of life.
5 minutes
Pain Severity
Time Frame: 5 minutes
Pain severity will be scored between 0 and 10. The pain of nine different body part (neck, shoulder, elbow, wrist, upper back, lower back, hip, knee, ankle) will be examined by the subject's perception.
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
T.C. ORDU ÜNİVERSİTESİ

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hacettepe University
Giresun University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sevim ACARÖZ CANDAN, Bayan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 27, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OrduU4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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