<?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>IRCT20221129056664N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-17</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of telephone education based of Belief Model on abortion of married and abortion-prone mothers</public_title>
      <acronym></acronym>
      <scientific_title>The effect of telephone education based on the health belief model, on abortion among married mothers who are prone to abortion</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67126</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The researcher randomly selects 3 centers out of 5 comprehensive health centers through lottery. Sampling of people is done in an easy way from people who meet the criteria to enter the study, and then they are randomly placed in two intervention and control groups using a table of random numbers. Even numbers will be in the intervention group and odd numbers will be in the control group, Blinding description: In this research, the participants are completely unaware of whether they are in the intervention or control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Abortion of mothers. Condition 2: Other abortion.</hc_freetext>
      <i_freetext>Intervention group: Married women who are inclined to undergo induced abortion are trained by the researcher in order to make the right decision to continue the pregnancy, in a virtual way (through the educational hotline) and based on the content set based on the constructs of the health belief model. Before providing training, their intention to perform induced abortion is asked through questionnaires prepared in this field. The duration of training in the intervention group is estimated to be 1 to 1 and a half hours. It should be noted that if the intervention group asked for more description of the training or the researcher thought that they needed more explanation to better understand the content, the training packages will be prepared based on the results of the expert panel and will be available on Itai channel. Researchers are also trained.In these educational packages, in addition to the content (complications of abortion and the benefits of continued pregnancy), images and videos related to the complications of induced abortions are also shown, while the research samples can have questions and answers with the researcher. The control group only receives the complications of abortion in the form of a prepared pamphlet for the purpose of increasing knowledge. 1 week after the training (due to the possibility of immediate decision of the mothers to have an abortion), the researcher will contact both groups and complete the mentioned questionnaires again.Questionnaires will be completed once before the intervention and again 1 week after the training (according to the possibility of immediate decision of mothers to have an abortion). Due to the completion of the questionnaires by the researcher, we can be sure that the questionnaires will be completed completely. Also, through the presentation of gifts that will be delivered by comprehensive health service centers, the participation of people will be attracted to complete the questionnaires..</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Sohrabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jarib Ave</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>73461-81746</zip>
        <telephone>+98 31 3792 7546</telephone>
        <email>zsohrabi@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Sohrabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jarib Ave</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>73461-81746</zip>
        <telephone>+98 31 3792 7546</telephone>
        <email>zsohrabi@nm.mui.ac.ir</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>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Have Iranian nationality
Women who have a desire and informed consent to participate in the study
The gestational age of women is less than 14 weeks
Be married and officially married
Be a resident of Isfahan city
Women who are mentally healthy</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Women who intend to drop out during or after receiving training.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O00-O08</hc_code>
      <hc_code>005</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pregnancy with abortive outcome</hc_keyword>
      <hc_keyword>Other abortion</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Married women who are inclined to undergo induced abortion are trained by the researcher in order to make the right decision to continue the pregnancy, in a virtual way (through the educational hotline) and based on the content set based on the constructs of the health belief model. Before providing training, their intention to perform induced abortion is asked through questionnaires prepared in this field. The duration of training in the intervention group is estimated to be 1 to 1 and a half hours. It should be noted that if the intervention group asked for more description of the training or the researcher thought that they needed more explanation to better understand the content, the training packages will be prepared based on the results of the expert panel and will be available on Itai channel. Researchers are also trained.In these educational packages, in addition to the content (complications of abortion and the benefits of continued pregnancy), images and videos related to the complications of induced abortions are also shown, while the research samples can have questions and answers with the researcher. The control group only receives the complications of abortion in the form of a prepared pamphlet for the purpose of increasing knowledge. 1 week after the training (due to the possibility of immediate decision of the mothers to have an abortion), the researcher will contact both groups and complete the mentioned questionnaires again.Questionnaires will be completed once before the intervention and again 1 week after the training (according to the possibility of immediate decision of mothers to have an abortion). Due to the completion of the questionnaires by the researcher, we can be sure that the questionnaires will be completed completely. Also, through the presentation of gifts that will be delivered by comprehensive health service centers, the participation of people will be attracted to complete the questionnaires.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Perceived sensitivity score. Timepoint: It will be done once before the educational intervention and once a week after the intervention. Method of measurement: Researcher made Questionnaire.</prim_outcome>
      <prim_outcome>Perceived threat score. Timepoint: It will be done once before the educational intervention and once a week after the intervention. Method of measurement: Researcher made Questionnaire.</prim_outcome>
      <prim_outcome>Perceived barriers score. Timepoint: It will be done once before the educational intervention and once a week after the intervention. Method of measurement: Researcher made Questionnaire.</prim_outcome>
      <prim_outcome>Perceived benefits score. Timepoint: It will be done once before the educational intervention and once a week after the intervention. Method of measurement: Researcher made Questionnaire.</prim_outcome>
      <prim_outcome>Self-efficacy score. Timepoint: It will be done once before the educational intervention and once a week after the 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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-22</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar Jarib Ave Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
