<?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>IRCT20230730058980N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-07</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Investigation the effect of a program based on participatory ergonomics on musculo_skletal disorders and general health of the operating room personnel</public_title>
      <acronym></acronym>
      <scientific_title>Investigation the effect of a program based on participatory ergonomics on musculo_skletal disorders and general health of the operating room personnel</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71675</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Due to the nature of collaborative ergonomics that may be affected by the environment, it is not possible to select the test and control group from one hospital in order to carry out the study, therefore, for random allocation, one hospital will be randomly selected from among the selected hospitals through lottery.  The intervention site and two other hospitals are selected as controls.
  In the next step, after determining the hospital where the intervention will take place, first, the people who meet the criteria to enter the study are selected using the available method, and then 44 personnel are placed in the test group by simple random allocation and using a table of random numbers.
 In the hospitals of the control group, after the identification of the hospitals, first, the people who meet the criteria for entering the study are selected using the available method, and then by simple random allocation and using a table of random numbers, 22 personnel from each hospital will be in the control group.  Placed.
 Finally, in order to compare the data, the number of selected people in each of the surgical fields in the test and control groups are selected in equal numbers, Blinding description: The statistical analyst has no knowledge of the intervention and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Musculoskeletal disorders and general health.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In order to conduct the research, all the subjects complete a written consent form.  The studied units are free to refuse or accept participation in the research.  At first, all the subjects in the control and test groups completed the questionnaires and the information obtained from the research tools was analyzed and the initial evaluation was done.  Then the researcher uses a camera to take pictures of the personnel while doing the work.  The purpose of doing this work is to evaluate the condition of the body parts of people during work using the quick assessment checklist of the whole body.  In order to implement participatory ergonomics in the test group, first a meeting is held with the hospital management and the operating room manager of the selected hospital, which is randomly selected as the intervention hospital, and the objectives of the study are explained in order to implement the necessary cooperation plan.  Have.  Then the ergonomics team is formed and meetings related to collaborative ergonomics are held.  It is taught to the ergonomics team by the researcher and with the personal supervision of an expert in ergonomics.  After that, a brainstorming session is held and the solutions provided by the ergonomics team are documented. The most important problems and suggested measures are selected for implementation according to the interests of the personnel and officials. Intervention 2: Control group: No intervention is performed 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 is potentially shareable after de-identifying individuals

When:
The access period starts 3 months after the results are published

To whom:
Researchers working in academic and scientific institutions and people working in industry

Conditions:
The use of documents is allowed with reference to the source.

Where to obtain:
Mahshid Ahmadi
mahshid.ahd74@gmail.com

How to obtain:
Send a request email and it takes about a week for a response.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahshid Ahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>lsfahan university of medical science, Hezar jarib blvd, Isfahan town</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 71 4254 3971</telephone>
        <email>mahshid.ahd74@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahshid Ahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>lsfahan university of medical science, Hezar jarib blvd, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 71 4254 3971</telephone>
        <email>mahshid.ahd74@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Expression of desire to participate in the study
At least one year of work experience in the operating room
Absence of musculoskeletal disorders, in such a way that prevents ergonomic interventions
Absence to perform spine surgery
Not having a second job
Absence of pregnancy
Absence of cardiovascular and respiratory diseases based on self-report
No history of mental illnesses and taking psychiatric drugs based on self-report
Failure to participate in stress control classes based on self-report</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to continue cooperation
Lack of active participation and completion of the questionnaire</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: In order to conduct the research, all the subjects complete a written consent form.  The studied units are free to refuse or accept participation in the research.  At first, all the subjects in the control and test groups completed the questionnaires and the information obtained from the research tools was analyzed and the initial evaluation was done.  Then the researcher uses a camera to take pictures of the personnel while doing the work.  The purpose of doing this work is to evaluate the condition of the body parts of people during work using the quick assessment checklist of the whole body.  In order to implement participatory ergonomics in the test group, first a meeting is held with the hospital management and the operating room manager of the selected hospital, which is randomly selected as the intervention hospital, and the objectives of the study are explained in order to implement the necessary cooperation plan.  Have.  Then the ergonomics team is formed and meetings related to collaborative ergonomics are held.  It is taught to the ergonomics team by the researcher and with the personal supervision of an expert in ergonomics.  After that, a brainstorming session is held and the solutions provided by the ergonomics team are documented. The most important problems and suggested measures are selected for implementation according to the interests of the personnel and officials.</i_keyword>
      <i_keyword>Control group: No intervention is performed in the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The score of Musculo_skeletal disorders based on the Cornell questionnaire. Timepoint: Before the intervention, 3 months and 6 months later. Method of measurement: Cornell Musculoskeletal Disorders Questionnaire.</prim_outcome>
      <prim_outcome>General health based on the 28-item general health questionnaire. Timepoint: Before the intervention, 3 months and 6 months later. Method of measurement: 28-item general health 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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-28</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar jerib blv Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
