<?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>IRCT20200602047640N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-07</date_registration>
      <primary_sponsor>Research Deputy of Tarbiat Modares University</primary_sponsor>
      <public_title>The effect of health promotion interventions on musculoskeletal disorders in housewives</public_title>
      <acronym></acronym>
      <scientific_title>The effect of health promotion interventions based on a participatory ergonomic approach to improve the quality of life of housewives with musculoskeletal disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49375</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The sample size in the quantitative phase will be calculated as 30 persons for each group according to the following formula, and considering the dropout rate of 30%, 40 persons will be selected as the participants in each group.
 A total of 160 persons will be selected as the participants in the four groups (the three intervention groups plus one control group). The sampling method at this phase is permuted block randomization. This randomization process gives each participant an equal chance of being placed in each group. Conducting successful randomization requires that the researchers and the participants not be able to predict the type of interventions that will be delivered.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Neck pain. Condition 2: Back pain. Condition 3: Shoulder pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group Based on the design of the randomized controlled trial intervention, the impact of the intervention program on musculoskeletal disorders, workability, and quality of life of the housewives will be evaluated. At this phase,  women who meet the criteria to be included in the study will be randomly allocated to four groups; (1) Biomechanical Intervention Group (2) Psychosocial Intervention Group (3) Multidisciplinary Intervention Group (Biomechanical and Psychosocial), and (4) Control Group. For psychosocial intervention groups, the required training content will be provided following the conceptual framework developed in the qualitative study and the resulting theory. Besides, for the biomechanical intervention group, the required training will be provided following the conceptual framework derived from the qualitative study and job safety analysis (JSA) method. Finally,  mixed training provided for the previous two groups will be applied for the comprehensive intervention group. After providing the required training programs, the participants in the three intervention groups will be divided into 10 subgroups (4 subgroups for each group and 12 subgroups in total). Intervention 2: Control group: After the final evaluation and comparisons of the three intervention groups, the participants in the control group also will receive the training interventions based on ethical principles.</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:
I have no decision yet

When:
22. 9. 2023

To whom:
The person who evaluates the outcome
 Analytic person 
 Journal Reviewer 
 Executor of plan

Conditions:
To evaluate the outcome
 Data analysis and validation of data
 Under the conditions of the triple-blind

Where to obtain:
Executor of plan

How to obtain:
It is requested by e-mail to the project implementer with the address: tavafian@modares.ac.ir

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,Jalal Al Ahmad, Paul Nasr</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>111-14115</zip>
        <telephone>+98 21 8288 3590</telephone>
        <email>tavafian@modares.ac.ir</email>
        <affiliation>Department of Health Education,Faculty of Medical Sciences, 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, Jalal Al Ahmad, Paul Nasr</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>111-14115</zip>
        <telephone>+98 21 8288 3590</telephone>
        <email>tavafian@modares.ac.ir</email>
        <affiliation>Department of Health Education, School of Medical Sciences, Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being married and living with the family
The motivation and willingness to participate in the study
Having an MSD pain intensity score of 4 and higher based on the visual analog scale (VAS)
Having no job other than housekeeping
Having no child under 2 years of age
Not taking medication to treat a mental illness</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Not be willing to participate in the study
Becoming pregnant during the study
The occurrence of an event or accident that does not allow the person to complete the whole study procedure</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_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 Based on the design of the randomized controlled trial intervention, the impact of the intervention program on musculoskeletal disorders, workability, and quality of life of the housewives will be evaluated. At this phase,  women who meet the criteria to be included in the study will be randomly allocated to four groups; (1) Biomechanical Intervention Group (2) Psychosocial Intervention Group (3) Multidisciplinary Intervention Group (Biomechanical and Psychosocial), and (4) Control Group. For psychosocial intervention groups, the required training content will be provided following the conceptual framework developed in the qualitative study and the resulting theory. Besides, for the biomechanical intervention group, the required training will be provided following the conceptual framework derived from the qualitative study and job safety analysis (JSA) method. Finally,  mixed training provided for the previous two groups will be applied for the comprehensive intervention group. After providing the required training programs, the participants in the three intervention groups will be divided into 10 subgroups (4 subgroups for each group and 12 subgroups in total).</i_keyword>
      <i_keyword>Control group: After the final evaluation and comparisons of the three intervention groups, the participants in the control group also will receive the training interventions based on ethical principles.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The quality of life in the  people of  common musculoskeletal disorders. Timepoint: Before, three and six months after the intervention. Method of measurement: Using a  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>Research Deputy of Tarbiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-18</approval_date>
        <contact_name>Ethics Committee in Tarbiat Modares University</contact_name>
        <contact_address>Tarbiat Modares University, Jalal Ahmad Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
