<?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>IRCT20230422057974N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-07</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Investigating The Effects of Ergonomic Training Interventions Based on Precede-Proceed Model on musculoskeletal disorders And Stress In Surgical Technologists</public_title>
      <acronym></acronym>
      <scientific_title>Investigating The Effects of Ergonomic Training Interventions Based on Precede-Proceed Model on musculoskeletal disorders And Stress In Surgical Technologists</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69741</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Musculoskeletal Disorders. Condition 2: Stress.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Seven face-to-face training sessions will be held for surgical technologists.  The duration of each seven sessions is 2 to 2.5 hours and the training will include theoretical and practical components.The first session is an introduction to the concepts of predisposing factors - knowledge with the following topics: What is ergonomics? What is workplace syndrome? What is musculoskeletal disorder? What is stress? In the second session, predisposing attitudinal factors will be discussed and people's attitude towards factors affecting musculoskeletal disorders and the effectiveness of preventive behaviors will be presented. Enabling factors will be introduced in the third and fourth sessions. These items include: the use of educational programs to prevent skeletal diseases, teaching appropriate exercises to prevent musculoskeletal disorders and reduce stress, ergonomic principles in purchasing ergonomic aids for the workplace (introduction of equipment, application, importance of use and desired organs) and the principles of correct body posture during work. The fifth session will be a review of the materials presented in the previous sessions. Also, training related to stress based on Lazarus and Folkman's interactive model of dealing with stress will be conducted in the sixth and seventh sessions. Intervention 2: Control group: There is no intervention in the control group.</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:
All data can be shared after de-identifying individuals.

When:
The access period starts 6 months after the results are published

To whom:
All people, including researchers working in academic and scientific institutions, industry, etc., will be allowed to access the data.

Conditions:
There are no special conditions.

Where to obtain:
Mozhgan Amiri's 
email address: mozhganamiri2345@gmail.com

How to obtain:
Applicants should submit their application through the mentioned email, then their application will be processed as soon as possible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mozhgan Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 3, No. 6, 14th Dead End, Rajaei Street, Shahid Beheshti Blvd, Hesarak</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3197638188</zip>
        <telephone>+98 26 3455 3193</telephone>
        <email>mozhganamiri2345@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hamidreza Makrami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Health, Shiraz University of Medical Sciences</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71645111</zip>
        <telephone>0098 71 137251001</telephone>
        <email>hamidreza.mokarami@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having more than one year of work experience as a surgical technologist
Desire to participate in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a history of surgery or any accident that affects the musculoskeletal area</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Seven face-to-face training sessions will be held for surgical technologists.  The duration of each seven sessions is 2 to 2.5 hours and the training will include theoretical and practical components.The first session is an introduction to the concepts of predisposing factors - knowledge with the following topics: What is ergonomics? What is workplace syndrome? What is musculoskeletal disorder? What is stress? In the second session, predisposing attitudinal factors will be discussed and people's attitude towards factors affecting musculoskeletal disorders and the effectiveness of preventive behaviors will be presented. Enabling factors will be introduced in the third and fourth sessions. These items include: the use of educational programs to prevent skeletal diseases, teaching appropriate exercises to prevent musculoskeletal disorders and reduce stress, ergonomic principles in purchasing ergonomic aids for the workplace (introduction of equipment, application, importance of use and desired organs) and the principles of correct body posture during work. The fifth session will be a review of the materials presented in the previous sessions. Also, training related to stress based on Lazarus and Folkman's interactive model of dealing with stress will be conducted in the sixth and seventh sessions.</i_keyword>
      <i_keyword>Control group: There is no intervention in the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Leveling the risk of not doing ergonomic work based on the Rapid Entire Body Assessment method. Timepoint: Risk stratification based on the Rapid Entire Body Assessment method before the intervention, 3 months and 6 months after the intervention. Method of measurement: Rapid Entire Body Assessment body condition assessment checklist.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Predisposing factors score. Timepoint: Before the start of the intervention, 3 and 6 months after the intervention. Method of measurement: The questionnaire of behavioral factors  will be designed based on the precede - proceed  model.</sec_outcome>
      <sec_outcome>Enabling factors score. Timepoint: Before the start of the intervention, 3 and 6 months after the intervention. Method of measurement: The questionnaire of behavioral factors will be designed based on the asked-asked model.</sec_outcome>
      <sec_outcome>Enhancing factors score. Timepoint: Before the start of the intervention, 3 and 6 months after the intervention. Method of measurement: The questionnaire of behavioral factors will be designed based on the asked-asked model.</sec_outcome>
      <sec_outcome>Behavior score. Timepoint: Before the start of the intervention, 3 and 6 months after the intervention. Method of measurement: The questionnaire of behavioral factors will be designed based on the asked-asked model.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-17</approval_date>
        <contact_name>Ethics Committee of Health Faculty - Shahid Sadougi University of Medical Sciences, Yazd</contact_name>
        <contact_address>Yazd Faculty of Health, Pardis of Shahid Sadoughi University of Medical Sciences and Health Services, Shohada Anonymous Blvd, Alam Square Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
