<?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>IRCT20180218038783N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-19</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of gamification method for delivery protocol training on midwifery students</public_title>
      <acronym></acronym>
      <scientific_title>Design and implementation of delivery protocol training for midwifery students with an application based on gamification method and evaluation of its usage by midwifery students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>35</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74815</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Natural delivery.</hc_freetext>
      <i_freetext>Intervention: All students who consent to participate in the study will be randomly divided into two groups. Half of the topics for one group (intervention) will be taught with gamification method and for the second group (control) with conventional method, and in the continuation of the study, the other half of the topics for the primary control group will be taught with gamification method and for the primary intervention group with the conventional method will be taught. Some topics of natural and unnatural childbirth practice (vaginal examination, control of mother's vital signs, control of fetal heart rate, control of uterine contractions,placental examination, drawing of partographs and investigation of episiotomy) in both gamification and traditional forms with contents It will be prepared exactly the same. Before starting the study, the students will complete the 20-question knowledge assessment test as well as the demographic and emotional intelligence questionnaire of Siberia Sharing, and their performance at the mother's bedside will be evaluated using a checklist. Four weeks after the completion of the interventions, the students will respond to the delivery protocol test and their performance at the mother's bedside will be evaluated using a designed checklist..</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>Fereshteh Behmanesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol University of Medical Sciences, University Square, Ganj Afrooz Street, Babol.</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>47745-471676</zip>
        <telephone>+98 11 3219 9592</telephone>
        <email>f.behmanesh2015@gmail.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fereshteh Behmanesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol University of Medical Sciences, Universit, Baboly Square, Ganj Afrooz Street.</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4718758563</zip>
        <telephone>+9832199594</telephone>
        <email>f.behmanesh2015@gmail.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Obtaining written consent from students to participate in the study
Obtaining the course unit of natural and abnormal childbirth internship
Midwifery student</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Failure to take the training course of natural and unnatural childbirth in the previous semesters</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z55</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Problems related to education and literacy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention: All students who consent to participate in the study will be randomly divided into two groups. Half of the topics for one group (intervention) will be taught with gamification method and for the second group (control) with conventional method, and in the continuation of the study, the other half of the topics for the primary control group will be taught with gamification method and for the primary intervention group with the conventional method will be taught. Some topics of natural and unnatural childbirth practice (vaginal examination, control of mother's vital signs, control of fetal heart rate, control of uterine contractions,placental examination, drawing of partographs and investigation of episiotomy) in both gamification and traditional forms with contents It will be prepared exactly the same. Before starting the study, the students will complete the 20-question knowledge assessment test as well as the demographic and emotional intelligence questionnaire of Siberia Sharing, and their performance at the mother's bedside will be evaluated using a checklist. Four weeks after the completion of the interventions, the students will respond to the delivery protocol test and their performance at the mother's bedside will be evaluated using a designed checklist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knowledge and performance of the delivery protocol. Timepoint: Before, immediately and one month after the study, it is evaluated through a questionnaire and a checklist of performance at the mother's bedside. Method of measurement: The delivery protocol knowledge questionnaire: This questionnaire contains 20 questions from the national guide to the provision of midwifery and maternity services and from six topics presented, designed by the researcher.  Checklist for the performance of the delivery protocol: This checklist is made up of six topics designed by the research team and each student will be evaluated separately by the researcher on the mother's clinic.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Student satisfaction. Timepoint: Upon completion of the intervention will be completed by the students. Method of measurement: The questionnaire includes questions to measure student satisfaction with the interventions.(Designed by the researcher.).</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>Smart University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-01-02</approval_date>
        <contact_name>Ethic Committee of the University of Intelligent Medical Sciences</contact_name>
        <contact_address>Number 3, First Avenue, Koh Noor Street, Motahari Street, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
