<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20170704034900N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-08-12</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>Effects of an Ergonomic Education on Musculoskeletal Disorders and Job Satisfaction at a Detergent Manufacturing Company</public_title>
      <acronym></acronym>
      <scientific_title>Effects of an Ergonomic Education on Musculoskeletal Disorders and Job Satisfaction at a Detergent Manufacturing Company</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/85415</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: The control group attends sham classes that include topics unrelated to the main intervention, Randomization description: In this study, eligible workers who provide consent and comply with existing protocols will be randomly allocated (random allocation) into groups. All workers are numbered from 1 to n, and using blocks of four and a random number table, selected employees are assigned according to a predetermined list into two groups: intervention and control. This approach ensures two balanced groups equal in number and guarantees that the two groups will not have significant differences in baseline and confounding factors, Blinding description: In this type of study, only the participants are unaware of their group assignment (intervention or control), while the researchers and assessors are aware of the intervention type. In this research, after measuring the study variables at baseline, participants were divided into two groups: intervention and control. The intervention group received specialized and practical ergonomic training, while the control group continued their usual workplace activities without specialized training (nutrition, stress management, and general ergonomic topics).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Musculoskeletal Disorders.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants in the intervention group will receive specialized ergonomic training through a course lasting at least 120 minutes, followed by a two-week follow-up period. The workshop content, delivered via lectures, videos, and practical workstation adjustments, includes:1. Introduction to ergonomics and its principles2. Work-related musculoskeletal disorders with an emphasis on the detergent manufacturing industry3. Ergonomic solutions for office environments, such as workstation setup, manual handling, work-rest cycles, participatory ergonomics, and more4. Ergonomic principles for managing musculoskeletal disorders5. Encouragement of workplace exercise and stretching6. Recommendations for isometric muscle strengthening exercises7. Techniques for reducing psychological stress and improving workplace communicationAll educational content for both intervention and control groups will be delivered by an occupational medicine specialist. The book *Introduction to Ergonomics* will be used as the reference for preparing the training materials. Intervention 2: Control group: Control group: The control group will receive general and non-specialized training (nutrition, stress management, and general ergonomic topics).</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Personal identity data (such as name, national ID number, contact information, and any personal identifiers) are completely removed and not included in the shared files.
All data, after undergoing a de-identification process, including research data and results, are shared anonymously without any possibility of tracing individual identities.
Data related to the primary study outcomes (such as ergonomic risk assessment scores, prevalence of musculoskeletal disorders, and job satisfaction scores) will be shared without full demographic details.
Data related to educational interventions and their implementation will be provided in summary form, without personal information, as accompanying documentation.

When:
The access period will begin 6 months after the publication of the results.

To whom:
Requests for data and documentation will only be accepted from researchers, graduate students, or reputable research institutions that have clear research objectives and adhere to ethical research principles.

Conditions:
Formal Request:
The request must be submitted in writing and include a full description of the purpose and the type of analysis or intended use of the data and documents. The applicant must also guarantee that the data will only be used for the specified purposes.

Confidentiality and Ethics Agreement:
Before receiving the data, the requester must sign a Non-Disclosure Agreement (NDA) and a commitment to adhere to ethical principles and protect the research data.

Permitted Types of Analysis:
Statistical and research analyses aligned with the primary objectives of the study and aimed at advancing knowledge in ergonomics, occupational health, or related fields are permitted. Any commercial use, reproduction of data for non-research purposes, or analyses violating ethical principles is prohibited.

Restrictions on Further Sharing:
Received data cannot be transferred or shared with any other individual or entity without prior written permission from the data owner.

Reporting Results:
The researcher is obliged to present the results of the data analysis in the form of a report or scientific article and provide a copy of the results to the data owner.

Privacy Protection:
Data usage must ensure the privacy of participants is maintained, and no information that could reveal individual identities will be disclosed.

Where to obtain:
Semnan, Basij Boulevard, Central Headquarters of Semnan University of Medical Sciences, Deputy of Research and Technology
Phone: +98 23 3345 1336
Email: [sem.ums.res@gmail.com]

How to obtain:
Preparation of Official Request
The applicant must prepare a formal letter or request form including:
• A detailed description of the research purpose and intended use of the data
• The type of required data and documents
• The planned analysis or use of the data
This step usually takes 2 to 5 business days.

Submitting the Request to the Research Team
The request should be sent to the email address or portal designated by the research data manager.

Initial Review of the Request
The research team reviews the request for completeness, alignment of objectives with research policies, and applicant’s eligibility.
This step typically takes 5 to 10 business days.

Request for Additional Documents (if needed)
If more documents are required (e.g., CV, proposal, introduction letter), the applicant will be asked to provide them.
The duration depends on the applicant’s response time (usually 5 business days).

Signing Agreements and Commitments
After preliminary approval, the applicant must sign and submit the confidentiality agreement and the ethical research commitment.
This step takes 3 to 7 business days.

Final Approval and Data Preparation
Upon receipt of signed agreements, the research team issues final permission and prepares the requested data and documents, ensuring de-identification.
This process usually takes 7 to 14 business days.

Sending Data and Documents to the Applicant
Data will be sent securely (e.g., via data portal, encrypted email, or secure drive).
Depending on the delivery method, this step may take 1 to 3 business days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>دکتر داریوش پهلوان</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Headquarters, Semnan University of Medical Sciences and Health Services, Basij Boulevard, Semnan, Iran</address>
        <city>semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3514799442</zip>
        <telephone>+98 23 3344 1022</telephone>
        <email>dpahlevan@semums.ac.ir</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>دکتر داریوش پهلوان</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Headquarters, Semnan University of Medical Sciences and Health Services, Basij Boulevard, Semnan, Iran</address>
        <city>semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3514799442</zip>
        <telephone>+98 23 3344 1022</telephone>
        <email>dpahlevan@semums.ac.ir</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18–65 years
Employment in a detergent manufacturing factory
Having at least one year of work experience in a factory
No history of severe inflammatory diseases (such as rheumatoid arthritis) or serious musculoskeletal injuries (such as recent fractures)
No recent surgery on the musculoskeletal system (e.g., lumbar disc surgery in the past 6 months)
Willingness of individuals to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of participant consent to continue the intervention at any stage of the process
Absence from the workplace for more than 2 weeks during the study
History of recent traumatic events (such as accidents in the past 3 months)
Continuous use of strong painkillers (which may distort pain reporting)
History of receiving ergonomic training in the past 6 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M99.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Biomechanical lesion, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Participants in the intervention group will receive specialized ergonomic training through a course lasting at least 120 minutes, followed by a two-week follow-up period. The workshop content, delivered via lectures, videos, and practical workstation adjustments, includes:1. Introduction to ergonomics and its principles2. Work-related musculoskeletal disorders with an emphasis on the detergent manufacturing industry3. Ergonomic solutions for office environments, such as workstation setup, manual handling, work-rest cycles, participatory ergonomics, and more4. Ergonomic principles for managing musculoskeletal disorders5. Encouragement of workplace exercise and stretching6. Recommendations for isometric muscle strengthening exercises7. Techniques for reducing psychological stress and improving workplace communicationAll educational content for both intervention and control groups will be delivered by an occupational medicine specialist. The book *Introduction to Ergonomics* will be used as the reference for preparing the training materials.</i_keyword>
      <i_keyword>Control group: Control group: The control group will receive general and non-specialized training (nutrition, stress management, and general ergonomic topics).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Musculoskeletal Disorders. Timepoint: 3 months after the intervention. Method of measurement: Nordic questionnaire and REBA checklist.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Job Satisfaction. Timepoint: Before and after the intervention. Method of measurement: Minnesota Job Satisfaction Questionnaire.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-07-21</approval_date>
        <contact_name>Ethics committee of Semnan University of Medical Sciences</contact_name>
        <contact_address>Deputy of Research and Technology, Central Headquarters, Semnan University of Medical Sciences, Basij Boulevard, Semnan, Iran semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
