<?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>IRCT20200224046603N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-14</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating Educational Intervention Based on Precaution Adoption Process Model on Preventive Behavior Cervical Cancer among Women Sub Urban Bandar Abbas</public_title>
      <acronym></acronym>
      <scientific_title>Developing, Implementing and Evaluating Educational Intervention Based on Precaution Adoption Process Model on Preventive Behavior Cervical Cancer among Women Sub Urban Bandar Abbas</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>300</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46119</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The target group was the study of married women over 20 years old living in the suburbs of Bandar Abbas. The study was performed as a control and intervention group. The randomization method was simple randomly selected from the family records covered by health centers for the target group of the study and then randomly from the family number, the target group was divided into two groups with equal number: Control and intervention groups were divided.</study_design>
      <phase>N/A</phase>
      <hc_freetext>cervical cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: includes married women over 20 years old living in suburbs of Bandar Abbas.The intervention group received training needs assessment and then based on the needs assessment, interventions were performed on the intervention group. Designed educational interventions included PowerPoint lecture, group discussion, pamphlet production and distribution, poster and banner and individual and group training based on cervical cancer model construct constructs on intervention group. , After the training interventions are implemented at the end of the test post. Intervention 2: Control group: includes married women over 20 years old living in suburbs of BandarAbbass. There was only educational need assessment on this group but no additional work was done on the control group. After a specified period of time the test post is performed on 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is نیاز به مطالعات بیشتری برای انتشار دارم</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Asadian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Damahi</address>
        <city>Bandarabbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>336689717</zip>
        <telephone>+98 76 3389 1766</telephone>
        <email>a.assadian.a@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Saeed Mazloomy Mahmoodabad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Campus of Medical Sciences, College of Medical Sciences, Alam Square, Yazd, Iran,</address>
        <city>yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173160</zip>
        <telephone>+98 35 3820 9138</telephone>
        <email>mazloomy.mm@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Married women over twenty
resident in the area
interested in participating in the research</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Migration,
Particular disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D06</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Carcinoma in situ of cervix uteri</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: includes married women over 20 years old living in suburbs of Bandar Abbas.The intervention group received training needs assessment and then based on the needs assessment, interventions were performed on the intervention group. Designed educational interventions included PowerPoint lecture, group discussion, pamphlet production and distribution, poster and banner and individual and group training based on cervical cancer model construct constructs on intervention group. , After the training interventions are implemented at the end of the test post.</i_keyword>
      <i_keyword>Control group: includes married women over 20 years old living in suburbs of BandarAbbass. There was only educational need assessment on this group but no additional work was done on the control group. After a specified period of time the test post is performed on the control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cancer Prevention Behaviors. Timepoint: Before and 3 months after intervention. Method of measurement: The questionnaire included demographic variables, intervention variables based on behavioral model.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Perceived Sensitivity,. Timepoint: Before and 3 months after intervention. Method of measurement: The questionnaire included demographic variables, intervention variables based on behavioral model.</sec_outcome>
      <sec_outcome>Perceived severity. Timepoint: Before and 3 months after intervention. Method of measurement: The questionnaire included demographic variables, intervention variables based on behavioral model.</sec_outcome>
      <sec_outcome>Perceived Benefits. Timepoint: Before and 3 months after intervention. Method of measurement: The questionnaire included demographic variables, intervention variables based on behavioral model.</sec_outcome>
      <sec_outcome>Perceived Fear and Concern. Timepoint: Before and 3 months after intervention. Method of measurement: The questionnaire included demographic variables, intervention variables based on behavioral model.</sec_outcome>
      <sec_outcome>Perceived Self-efficacy. Timepoint: Before and 3 months after intervention. Method of measurement: The questionnaire included demographic variables, intervention variables based on behavioral model.</sec_outcome>
      <sec_outcome>Perceived Social Norms about Cervical Cancer Prevention Behaviors. Timepoint: Before and 3 months after intervention. Method of measurement: The questionnaire included demographic variables, intervention variables based on behavioral model.</sec_outcome>
      <sec_outcome>Perceived barriers. Timepoint: Before and 3 months after intervention. Method of measurement: The questionnaire included demographic variables, intervention variables based on behavioral 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>2019-05-06</approval_date>
        <contact_name>Ethics Committee of Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>No. 12, Yazd University of Medical Sciences, Alam Square, Yazd, Iran Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
