<?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>IRCT20221031056354N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-19</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the Effect of Education Based on 7E Learning Cycle Model on Knowledge of Diabetic Foot Ulcer Prevention, Critical Thinking and Self-Efficacy</public_title>
      <acronym>7E</acronym>
      <scientific_title>Evaluation of the Effect of Education Based on 7E Learning Cycle Model on Knowledge of Diabetic Foot Ulcer Prevention, Critical Thinking and Self-Efficacy of Nursing Students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66620</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Allocation of students to two test and control groups will be done by a simple random method using the coin toss method and therefore, by chance, one of the two classes will be the test group and the other group will be the control group, Blinding description: Students of one of the two classes of the fourth semester of the Bachelor of Nursing course of the Faculty of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences will be randomly selected as the intervention group. Class A students have classes in the college on the first three days of the week and internships on the second three days of the week, but the program of class B students is the opposite, in that they have internships on the first three days of the week and classes on the second three days of the week. For this reason, the samples are not matched and all the participants think that they will receive the intervention, although the control group will receive the general education of adult and geriatric nursing course 3 (endocrine and diabetes) at the same time or in the last semester. and will not receive training on the prevention of diabetic foot ulcers based on the 7E learning cycle model.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetic Foot Ulcer.</hc_freetext>
      <i_freetext>Intervention 1: The participants of the intervention group will attend two 45-60 minute sessions of diabetic foot ulcer prevention training based on the 7E learning cycle model (Elicit, Engagement, Exploration, Explanation, Elaboration, Evaluation and Extending). The first session of training for students of the intervention group in the Faculty of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences and the second session in the hospitals covered by Shahid Beheshti University of Medical Sciences (Imam Hossein Hospital, Loghman-e Hakim Hospital, Shohadaye Tajrish Hospital, Shahid Labbafinezhad Hospital , Modarres Hospital) will be held. The students of the intervention group will be divided into groups of 6 to 8 people and for better education, they will attend at the patients’ be with diabetes at risk or with diabetic foot ulcers. Intervention 2: Control group:The participants of the control group will receive the common education of adult and elderly nursing course 3 (endocrine and diabetes) at the same time or in the last semester and will attend the relevant internships in the hospital.</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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehrad Nekouei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 5, No. 20, Bayat Alley, Saeed Arab St., Khaghani Crossroad, Damavand St, NewTehran .</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1745853576</zip>
        <telephone>+98 21 7748 1347</telephone>
        <email>mehrad.nekouei@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Fereshteh Javaheri Tehrani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>SBMU School of Nursing &amp; Midwifery, Vali Asr Ave., Niayesh Cross Road, Niayesh Complex, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>fereshte.javaheri@yahoo.com</email>
        <affiliation>Shahid Beheshti 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>Studying in the fourth semester of the Bachelor of Nursing course of the Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
Passing adult and elderly nursing course 3 (endocrine and diabetes) at the same time or in the last semester
Passing internship (clinical) units at the time of the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to participate in research
Attending or enrolling in advanced wound classes outside of the faculty schedule, prior to study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L97</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Non-pressure chronic ulcer of lower limb, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The participants of the intervention group will attend two 45-60 minute sessions of diabetic foot ulcer prevention training based on the 7E learning cycle model (Elicit, Engagement, Exploration, Explanation, Elaboration, Evaluation and Extending). The first session of training for students of the intervention group in the Faculty of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences and the second session in the hospitals covered by Shahid Beheshti University of Medical Sciences (Imam Hossein Hospital, Loghman-e Hakim Hospital, Shohadaye Tajrish Hospital, Shahid Labbafinezhad Hospital , Modarres Hospital) will be held. The students of the intervention group will be divided into groups of 6 to 8 people and for better education, they will attend at the patients’ be with diabetes at risk or with diabetic foot ulcers.</i_keyword>
      <i_keyword>Control group:The participants of the control group will receive the common education of adult and elderly nursing course 3 (endocrine and diabetes) at the same time or in the last semester and will attend the relevant internships in the hospital.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knowledge level score of diabetic foot ulcer prevention in Kaya questionnaire. Timepoint: At the beginning of the study (before the intervention) and one month after the educational intervention. Method of measurement: Diabetic foot ulcer prevention knowledge Kaya questionnaire.</prim_outcome>
      <prim_outcome>Critical thinking score in Ricketts questionnaire. Timepoint: At the beginning of the study (before the intervention) and one month after the educational intervention. Method of measurement: Ricketts Critical thinking questionnaire.</prim_outcome>
      <prim_outcome>Score of General Standard self-efficacy in Schwartzer &amp; Jerusalem questionnaire. Timepoint: At the beginning of the study (before the intervention) and one month after the educational intervention. Method of measurement: Schwartzer &amp; Jerusalem General Standard Self-Efficacy 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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-25</approval_date>
        <contact_name>Research Ethics Committees of School of Pharmacy and Nursing &amp; Midwifery- Shahid Beheshti University</contact_name>
        <contact_address>SBMU School of Nursing &amp; Midwifery, Vali Asr Ave., Niayesh Cross Road, Niayesh Complex, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
