<?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>IRCT20220825055792N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-23</date_registration>
      <primary_sponsor>Tarbiat Modares University</primary_sponsor>
      <public_title>Examining the effect of ergonomic intervention on preventive behaviors of musculoskeletal disorders</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of ergonomic intervention based on social cognitive theory in comparison with the control group on the preventive behaviors of musculoskeletal disorders in Women working on the assembly line</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65660</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: This study considers the limitations related to training in medium industries, such as the lack of separate training space and the lack of time allocation during working hours for the training of workers, and the design of the training intervention is based on the training theory and structured in the form of learning by doing approach in the environment. Work will be provided. Considering the role of several factors in the occurrence of musculoskeletal disorders related to work, in this research, social cognitive theory that considers the role of individual, environmental and behavioral factors in the form of theoretical constructs will be used. In this study, the scoring system based on the Bayesian network and fuzzy sets will be used, which is a more accurate evaluation method to provide the effectiveness of ergonomic interventions, in addition to the fact that the assessment of musculoskeletal disorders will be completed by self-reporting through the participants. The physical condition of the workers in each of the work stations will be evaluated using the advanced method of rapid assessment of the upper limbs through direct observation of the individual's tasks, during several work cycles and in all the work stations of the assembly line. Data will be collected within and between groups three weeks, 12 weeks, and 24 weeks after the intervention, Randomization description: Sampling will be cluster sampling method. First, two electronics industries will be randomly selected from among the electronics industries of Neyshabur city, and the allocation of industries to the control and intervention groups will be done randomly based on the throwing of dice, then from among the line workers. Assembling in each industrial unit, the workers have specified criteria for entering the study, and 80 participants from each industry are selected by simple random (a list of workers is prepared and based on a table of random numbers). The randomization unit is the industrial unit, Blinding description: In this study, the participants in the control group will also be provided with training unrelated to the main purpose of the research. Since the control and intervention groups are in two separate industries, the workers will not know how they will be assigned to the control or intervention group. Considering that the participants in the study will be identified based on the code, the people analyzing the data and results will be unaware of the names of the participants and the control and intervention groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>preventive behaviors of musculoskeletal disorders.</hc_freetext>
      <i_freetext>Intervention 1: The educational intervention will take advantage of the learning-by-doing approach in the form of social cognitive theory structures. The workers will correct their physical posture and exercise to continue using it simultaneously as their work activities. During daily rest periods, they will also do stretching exercises. Based on the most important predictor structures of the theory obtained from the first stage of the study, they will be taught that the main content of the training and the number of days the trainer should be present in the workplace will be adjusted. During the training program to improve the self-efficacy of women, with step-by-step training, an attempt will be made to facilitate the implementation of ergonomic behavior and to improve women's belief in their ability to apply behavior, as well as behaviors related to the correct body position in each of the work stations, as well as how to perform movements. Stretching will be shown practically and step-by-step in the work environment. Based on the obstacles and facilitators related to ergonomic behavior in the work environment, the researcher will try to provide suitable solutions to overcome each of the barriers as much as possible for each of the workers and also teach women to regularly monitor the recommended ergonomic behaviors at the end of each work shift. It will be possible, regarding the structure of social support, it is tried to accompany and support the trainer towards correcting inappropriate ergonomic behaviors in the workplace and encouraging women who are careful in applying the recommended behaviors. Educational posters will be installed in the work environment during the training and illustrated training booklets will be given to the workers. Intervention 2: Control group: This group will not receive the educational intervention and the follow-up of this group will be to complete the questionnaires in specific time intervals.</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:
Part of the data, such as the information related to the main and secondary outcomes, can be shared.

When:
The access period will start 6 months after the results are published.

To whom:
The data will be available only to researchers working in academic and scientific institutions.

Conditions:
The data will be sent by official request through academic or organizational e-mail of researchers after confirming and identifying the identity of the sender.

Where to obtain:
Data can be obtained via email at  hossini88ho@gmail.com.

How to obtain:
Applicants can apply for correspondence through email or postal address 6 months after printing the results, and a response will be given one week after sending the email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sedigheh Sadat Tavafian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Health Education, Faculty of Medical Sciences, Tarbiat Modares University, Nasr Bridge, Jalal Al-Ahmad Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>141115111</zip>
        <telephone>+98 21 8288 3590</telephone>
        <email>tavafian@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sedigheh  Sadat Tavafian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Health Education, Faculty of Medical Sciences,Tarbiat Modares University, Nasr Bridge, Jalal Al-Ahmad Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>141115111</zip>
        <telephone>+98 21 8288 3590</telephone>
        <email>tavafian@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being employed in the assembly line
having literacy
ability to participate in the program for at least six months
age 20 years and older
having consent to participate in the study</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having any disease that barred women from stretching
pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M95.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified acquired deformities of musculoskeletal system</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The educational intervention will take advantage of the learning-by-doing approach in the form of social cognitive theory structures. The workers will correct their physical posture and exercise to continue using it simultaneously as their work activities. During daily rest periods, they will also do stretching exercises. Based on the most important predictor structures of the theory obtained from the first stage of the study, they will be taught that the main content of the training and the number of days the trainer should be present in the workplace will be adjusted. During the training program to improve the self-efficacy of women, with step-by-step training, an attempt will be made to facilitate the implementation of ergonomic behavior and to improve women's belief in their ability to apply behavior, as well as behaviors related to the correct body position in each of the work stations, as well as how to perform movements. Stretching will be shown practically and step-by-step in the work environment. Based on the obstacles and facilitators related to ergonomic behavior in the work environment, the researcher will try to provide suitable solutions to overcome each of the barriers as much as possible for each of the workers and also teach women to regularly monitor the recommended ergonomic behaviors at the end of each work shift. It will be possible, regarding the structure of social support, it is tried to accompany and support the trainer towards correcting inappropriate ergonomic behaviors in the workplace and encouraging women who are careful in applying the recommended behaviors. Educational posters will be installed in the work environment during the training and illustrated training booklets will be given to the workers.</i_keyword>
      <i_keyword>Control group: This group will not receive the educational intervention and the follow-up of this group will be to complete the questionnaires in specific time intervals.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Body posture score during work from checklist of fuzzified Rapid Upper Limb Assessment. Timepoint: Before the intervention, 3, 12, 24 weeks after the educational intervention. Method of measurement: checklist of fuzzified Rapid Upper Limb Assessment.</prim_outcome>
      <prim_outcome>The score of stretching during work. Timepoint: Before the intervention, 3, 12, 24 weeks after the educational intervention. Method of measurement: Researcher-made questionnaire.</prim_outcome>
      <prim_outcome>Scores of constructs predicting social cognitive theory. Timepoint: Before the intervention, 3, 12, 24 weeks after the educational intervention. Method of measurement: Researcher-made questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Tarbiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-27</approval_date>
        <contact_name>Ethics committee of Tarbiat Modares University</contact_name>
        <contact_address>Tarbiat Modares University, Nasr Bridge, Jalal Al-Ahmad Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
