<?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>IRCT20160404027216N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-15</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of face-to-face and social network-based education based on the health belief model on model structures and breast self-examination behavior of women</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of face-to-face and social network-based education based on the health belief model on model structures and breast self-examination behavior of women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>159</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73923</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: 3 comprehensive health centers were selected by a simple random method from among 32 comprehensive health centers in Shiraz city, and after referring and coordinating with the relevant officials of the centers, women with entry criteria will be determined based on active cases in the Sib system, and then the samples will be contacted by phone. . The conditions of the research have been explained to the subjects and if they have consent, they will be entered into each of the intervention and control groups by random allocation method and permutation block method in 9 blocks of 18; Otherwise, according to the table of random numbers, the sample will be added to complete the number of 53 people in each center, Blinding description: The participants will be contacted separately and will enter the study, and the people of each group will be unaware of the existence of the other two groups.
  The data is provided to the data analyst in the form of three groups, and he is unaware of the intervention and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Constructs of health belief model related to breast cancer (Champion's Health Belief Model).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The participants in the study will first complete the informed consent form and the demographic information questionnaire and the Champion Health Belief Model through a virtual link sent to their mobile phone or in person.The people present in the face-to-face training group (based on the available facilities and the conditions of the face-to-face training group are divided into several smaller groups) also undergo face-to-face training about breast cancer and prevention methods based on the health belief model along with questions and answers, during six sessions - 60 30 minutes will be arranged; In this way, in the first session, after explaining the objectives and completing the questionnaire in person, the trainings related to the perceived sensitivity part and the second session of the perceived intensity will be presented and the questionnaire related to these two parts will be provided to the people. In the third session, the trainings related to the perceived benefits of self-examination, the fourth session, presentation of content and brainstorming among members about the perceived obstacles of self-examination, and finally, the fifth and sixth sessions will be presented on how and when to perform self-examination to increase self-efficacy in women. At the end of each session, people's questions are answered and the questionnaire related to the presented part is given to the women to complete. Then, two months after the intervention, the link of the aforementioned questionnaire will be sent again to the participants in the social network-based training group and the control group, and if they do not complete the questionnaire, they will be followed up through text messages and phone calls; The people present in the face-to-face group will also complete the questionnaire in person. In order to comply with the ethical codes, after completing the study, the educational content in the form of a pamphlet is provided to the control group. Intervention 2: Intervention group: The participants in the study will first complete the informed consent form and the demographic information questionnaire and the Champion Health Belief Model through a virtual link sent to their mobile phone or in person.First, in coordination with the women of the virtual training group, one of the software agreed upon by all the groups is installed on their mobile phones and a group is formed on the social network, then the people in the training group based on social networks, after completing the questionnaires, are trained virtually for 6 stage and will be placed once every two days. For this purpose, health and educational messages are based on the health belief model, which includes statistics related to the incidence of disease, risk factors in the development of disease, prevention and screening methods, and how to perform breast self-examination in six stages, in the form of text, video and photos compiled by the researcher. And based on the materials and sources approved by the Ministry of Health, it will be sent to them, and after studying each section, they will be requested to send a message confirming the study to the researcher. A time will be set aside after each stage, with the agreement of the people in this group, to respond online to possible questions and ambiguities after each stage, and the researcher will answer them. Then the link to the questions related to that part of the model structure will be sent to them for completion. Then, two months after the intervention, the link of the aforementioned questionnaire will be sent again to the participants in the social network-based training group and the control group, and if they do not complete the questionnaire, they will be followed up through text messages and phone calls; The people present in the face-to-face group will also complete the questionnaire in person. In order to comply with the ethical codes, after completing the study, the educational content in the form of a pamphlet is provided to the control group. Intervention 3: Control group: The participants in the study will first complete the informed consent form and the demographic information questionnaire and the Champion Health Belief Model through a virtual link sent to their mobile phone or in person.The control group will also receive common services and training from comprehensive health centers, and at the same time as they complete the questionnaire immediately after the intervention, they will also be provided with the link to complete the questionnaire.Then, two months after the intervention, the link of the aforementioned questionnaire will be sent again to the participants in the social network-based training group and the control group, and if they do not complete the questionnaire, they will be followed up through text messages and phone calls; The people present in the face-to-face group will also complete the questionnaire in person. In order to comply with the ethical codes, after completing the study, the educational content in the form of a pamphlet is provided to the control group. Then, two months after the intervention, the link of the aforementioned questionnaire will be sent again to the participants in the social network-based training group and the control group, and if they do not complete the questionnaire, they will be followed up through text messages and phone calls; The people present in the face-to-face group will also complete the questionnaire in person. In order to comply with the ethical codes, after completing the study, the educational content in the form of a pamphlet is provided to 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>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>Fatemeh Vizeshfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazrat Fatemeh  Midwifery Nursing School, Namazi Square, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4258</telephone>
        <email>vizeshfarf@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Vizeshfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazrat Fatemeh  Midwifery Nursing School, Namazi Square, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4258</telephone>
        <email>vizeshfarf@sum.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women with a minimum age of 18 and a maximum age of 50 years
Having literacy and the ability to work with a smart phone
Having informed consent to participate in the research
Absence of breast diseases in the past and present
Not having a history of participating in a training class on breast screening</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Moving people's place of residence
Absence of more than one session of people present in the face-to-face training intervention group
Failure to see the messages uploaded by the people in the social network-based intervention group and failure to send confirmation messages by them
Failure to answer more than 20% of the questions in each of the questionnaires before and after the intervention</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>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The participants in the study will first complete the informed consent form and the demographic information questionnaire and the Champion Health Belief Model through a virtual link sent to their mobile phone or in person.The people present in the face-to-face training group (based on the available facilities and the conditions of the face-to-face training group are divided into several smaller groups) also undergo face-to-face training about breast cancer and prevention methods based on the health belief model along with questions and answers, during six sessions - 60 30 minutes will be arranged; In this way, in the first session, after explaining the objectives and completing the questionnaire in person, the trainings related to the perceived sensitivity part and the second session of the perceived intensity will be presented and the questionnaire related to these two parts will be provided to the people. In the third session, the trainings related to the perceived benefits of self-examination, the fourth session, presentation of content and brainstorming among members about the perceived obstacles of self-examination, and finally, the fifth and sixth sessions will be presented on how and when to perform self-examination to increase self-efficacy in women. At the end of each session, people's questions are answered and the questionnaire related to the presented part is given to the women to complete. Then, two months after the intervention, the link of the aforementioned questionnaire will be sent again to the participants in the social network-based training group and the control group, and if they do not complete the questionnaire, they will be followed up through text messages and phone calls; The people present in the face-to-face group will also complete the questionnaire in person. In order to comply with the ethical codes, after completing the study, the educational content in the form of a pamphlet is provided to the control group.</i_keyword>
      <i_keyword>Intervention group: The participants in the study will first complete the informed consent form and the demographic information questionnaire and the Champion Health Belief Model through a virtual link sent to their mobile phone or in person.First, in coordination with the women of the virtual training group, one of the software agreed upon by all the groups is installed on their mobile phones and a group is formed on the social network, then the people in the training group based on social networks, after completing the questionnaires, are trained virtually for 6 stage and will be placed once every two days. For this purpose, health and educational messages are based on the health belief model, which includes statistics related to the incidence of disease, risk factors in the development of disease, prevention and screening methods, and how to perform breast self-examination in six stages, in the form of text, video and photos compiled by the researcher. And based on the materials and sources approved by the Ministry of Health, it will be sent to them, and after studying each section, they will be requested to send a message confirming the study to the researcher. A time will be set aside after each stage, with the agreement of the people in this group, to respond online to possible questions and ambiguities after each stage, and the researcher will answer them. Then the link to the questions related to that part of the model structure will be sent to them for completion. Then, two months after the intervention, the link of the aforementioned questionnaire will be sent again to the participants in the social network-based training group and the control group, and if they do not complete the questionnaire, they will be followed up through text messages and phone calls; The people present in the face-to-face group will also complete the questionnaire in person. In order to comply with the ethical codes, after completing the study, the educational content in the form of a pamphlet is provided to the control group.</i_keyword>
      <i_keyword>Control group: The participants in the study will first complete the informed consent form and the demographic information questionnaire and the Champion Health Belief Model through a virtual link sent to their mobile phone or in person.The control group will also receive common services and training from comprehensive health centers, and at the same time as they complete the questionnaire immediately after the intervention, they will also be provided with the link to complete the questionnaire.Then, two months after the intervention, the link of the aforementioned questionnaire will be sent again to the participants in the social network-based training group and the control group, and if they do not complete the questionnaire, they will be followed up through text messages and phone calls; The people present in the face-to-face group will also complete the questionnaire in person. In order to comply with the ethical codes, after completing the study, the educational content in the form of a pamphlet is provided to the control group. Then, two months after the intervention, the link of the aforementioned questionnaire will be sent again to the participants in the social network-based training group and the control group, and if they do not complete the questionnaire, they will be followed up through text messages and phone calls; The people present in the face-to-face group will also complete the questionnaire in person. In order to comply with the ethical codes, after completing the study, the educational content in the form of a pamphlet is provided to the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Perceived susceptibility score of breast cancer in Champion Health Belief Model Questionnaire. Timepoint: Before the intervention, immediately after the intervention, 2 months after the intervention. Method of measurement: Champion Health Belief Model Questionnaire.</prim_outcome>
      <prim_outcome>Perceived severity score of breast cancer in Champion Health Belief Model Questionnaire. Timepoint: Before the intervention, immediately after the intervention, 2 months after the intervention. Method of measurement: Champion Health Belief Model Questionnaire.</prim_outcome>
      <prim_outcome>The score of the perceived benefits of breast self-examination in the Champion Health Belief Model Questionnaire. Timepoint: Before the intervention, immediately after the intervention, 2 months after the intervention. Method of measurement: Champion Health Belief Model Questionnaire.</prim_outcome>
      <prim_outcome>The score of perceived barriers to breast self-examination in the Champion Health Belief Model Questionnaire. Timepoint: Before the intervention, immediately after the intervention, 2 months after the intervention. Method of measurement: Champion Health Belief Model Questionnaire.</prim_outcome>
      <prim_outcome>Self-efficacy score of breast self-examination in Champion health belief model questionnaire. Timepoint: Before the intervention, immediately after the intervention, 2 months after the intervention. Method of measurement: Champion Health Belief Model Questionnaire.</prim_outcome>
      <prim_outcome>Health motivation score in Champion Health Belief Model Questionnaire. Timepoint: Before the intervention, immediately after the intervention, 2 months after the intervention. Method of measurement: Champion Health Belief Model 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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-02-04</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Namazi Square, Faculty of Nursing and Midwifery of Hazrat Fatemeh Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
