- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06407453
Effectiveness of Exercise Given With Ergonomics Training in Tea Workers
October 25, 2024 updated by: Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
The aim of our study is to investigate the effectiveness of exercise against work-related musculoskeletal disorders in tea workers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Individuals who volunteer to participate in the study will be evaluated considering the inclusion and exclusion criteria, and participants will participate in the study after reading and signing the Informed Consent Form.
Tea workers who collect tea will be divided into 2 groups.
.Demographic Information Form, Visual Analogue Scale (VAS), Upper Extremity Discomfort Analysis, Rapid Upper Extremity Assessment (RULA), Sleep Quality, Scandinavian Musculoskeletal System Questionnaire will be given to the participants of both groups.
The surveys will be carried out face to face.
After the application of the surveys, statistical data will be obtained.
analyzes will be made.
One group will be given exercise, the other group will not be given exercise.
Post-exercise surveys will be conducted again to check the effectiveness of the exercise.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
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
-
-
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Istanbul, Turkey
- Uskudar University
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-
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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
INCLUSION CRITERIA
- Being between the ages of 25-45.
- Having been a tea craftsman for at least 10 years.
- Having the ability to read and write Turkish.
- Agreeing to participate in the study voluntarily.
EXCLUSION CRITERIA
- Being diagnosed with a serious psychological illness.
- Malignancy
- Advanced osteoporosis
- Being under 25 years of age.
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control
No intervention will be made
|
There will be no interference ergonomics training
|
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Experimental: exercise
exercise program will be applied
|
upper extremity strengthening exercises upper extremity stretching exercises ergonomics training posture training relaxation exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Arm Shoulder and Hand Problems Questionnaire
Time Frame: 14 weeks
|
It is a questionnaire developed by the American Academy of Orthopedic Surgeons (AAOS) based on the World Health Organization (WHO) model and used to evaluate upper extremity function status.
The survey consists of three parts, and for all questions in the scale, the person marks the answer that suits him or her on a 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: not able to do it at all).
According to the results of the Arm Shoulder and Hand Problems Questionnaire survey; A result between 0-100 is obtained from each section (0: no problem, 100: maximum problem).
|
14 weeks
|
|
Pittsburgh Sleep Quality Index
Time Frame: 14 weeks
|
The scale is a 19-item self-report scale that evaluates sleep quality and disturbance over the past month.
It consists of 24 questions, 19 questions are self-report questions, 5 questions are questions to be answered by the spouse or roommate.
The 18 scored questions of the scale consist of 7 components.
Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disturbance, Sleeping Medication Use, and Daytime Dysfunction.
Each component is evaluated on a scale of 0-3 points.
The total score of the 7 components gives the scale total score.
Total score varies between 0-21.
A total score greater than 5 indicates "poor sleep quality".
|
14 weeks
|
|
Nordic Musculoskeletal Survey
Time Frame: 14 weeks
|
It consists of 11 questions asked as a reference from 9 body regions shown on a visual body diagram of neck, shoulder, back, elbow, hand, wrist, waist, hip, thigh, knee, foot, ankle, and corresponds to 99 data items.
The questionnaire primarily questions the presence of pain in 9 body regions.
If the person's answer is yes, he moves on to the relevant sub-questions.It is a selection scale rather than a rating.
|
14 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: İlayda GÜR, Uskudar University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bhattacharyya N, Chakrabarti D. Ergonomic basket design to reduce cumulative trauma disorders in tea leaf plucking operation. Work. 2012;41 Suppl 1:1234-8. doi: 10.3233/WOR-2012-0308-1234.
- Mirbod SM, Fujita S, Miyashita K, Inaba R, Iwata H. Some aspects of occupational safety and health in green tea workers. Ind Health. 1995;33(3):101-17. doi: 10.2486/indhealth.33.101.
- Lallukka T, Hiilamo A, Oakman J, Manty M, Pietilainen O, Rahkonen O, Kouvonen A, Halonen JI. Recurrent pain and work disability: a record linkage study. Int Arch Occup Environ Health. 2020 May;93(4):421-432. doi: 10.1007/s00420-019-01494-5. Epub 2019 Nov 28.
- Marak TR, Bhagat D, Borah S. Musculoskeletal Disorders of Garo Women Workers Engaged in Tea-Plucking Activity: An Ergonomic Analysis. Indian J Occup Environ Med. 2020 May-Aug;24(2):60-65. doi: 10.4103/ijoem.IJOEM_185_19. Epub 2020 Aug 19.
- Kairi TK, Dey S. Prevalence of work-related musculoskeletal symptoms among tea garden workers in Bangladesh: a cross-sectional study. BMJ Open. 2022 May 9;12(5):e061305. doi: 10.1136/bmjopen-2022-061305.
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)
May 9, 2024
Primary Completion (Actual)
October 15, 2024
Study Completion (Actual)
October 25, 2024
Study Registration Dates
First Submitted
May 6, 2024
First Submitted That Met QC Criteria
May 6, 2024
First Posted (Actual)
May 9, 2024
Study Record Updates
Last Update Posted (Actual)
October 28, 2024
Last Update Submitted That Met QC Criteria
October 25, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Uskudar6
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.