<?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>IRCT2016070628817N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-09-14</date_registration>
      <primary_sponsor>Vice Chancellor for reserch of Mashhad University of Medical Scien</primary_sponsor>
      <public_title>The Effect of Teaching Decision Skills on the Students' Ethical Evolution</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of decision-making skills training on ethical development of midwifery students with two methods of problem solving and computer simulation in the face of professional ethics conflicts.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23283</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Decision-making skill in professional ethical dilemma.</hc_freetext>
      <i_freetext>Intervention 1: Interrention1:at the beginning of the study, a two-hour workshop for educating problem-solving oriented method will be conducted and groups will be established. Students will be assigned into eight groups of 5 and each group, besides the teacher, will have a team leader. Problem-solving education contains 5 steps: 1- reading the problem, 2-brain storming about the problem, 3- determining and prioritizing the learning topics, 4- searching and collecting the information and 5- sharing and merging the information and would be presented during 4 two-hour sessions and at the beginning of each session, three scenarios about three hypothetical patients with created ethical conflicts who require midwifery services, will be presented. Then, after 15 minutes of explanation for each case, using brain storming, learning needs would be determined and the required information sources for students will be introduced. At the end, with teacher’s cooperation, the topic will be discussed, concluded and modified. Intervention 2: Interrention2: In the computer simulation group, after preparation of the program, the provided version will be examined by the experts of midwifery and ethics. If approved, it will be applied at the same time as the problem-solving oriented group. Before the intervention, a two-hour workshop will be conducted for introducing the program’s environment to the students. Topics that will be presented to the students at the workshop are: stages of registry, different elements of accessing method and the method of using the program. Also, each participant will be given a username and a password to access the program. This group’s education will be conducted with researcher-made software based on problem-solving and as a computer simulation. The program contains an introduction page, a main page, a menu for selecting the scenario and 6 animated scenarios. The designed ethical scenario will be developed using a 6-step integrated ethical decision-making model (including recognizing the problem, finding the possible solutions, evaluating the solutions, selecting the best solution, applying the decision and evaluating the outcomes of the applied decision). It means that the learner will be asked to choose a problem. Before defining a specific problem, information will be gathered through the system. The questions will be aligned in a way that they will guide the learner toward solving the problem step-by-step. Recommending a replacement option for the learner will be provided by.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rehaneh Ashourzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneegh7, Avenue Danesh, Neghab</address>
        <city>Govine</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51145226104</telephone>
        <email>ashourzadehr931@mums.ac.ir</email>
        <affiliation>Mashhad Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Talat KhdiveZadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery Faculty, Mashhad University of Medical Sciences</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 5113859151113</telephone>
        <email>khadivzadeht@mums.ac.ir</email>
        <affiliation>Nursing and Midwifery Faculty, Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: being Iranian and Muslim,  having informed consent to participate in the study,  being a midwifery student, having passed the professional ethics course. &#13;
Exclusion criteria: nit participating in any problem-solving skill workshops or classes during the past 6 months</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z51</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other medical care</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Interrention1:at the beginning of the study, a two-hour workshop for educating problem-solving oriented method will be conducted and groups will be established. Students will be assigned into eight groups of 5 and each group, besides the teacher, will have a team leader. Problem-solving education contains 5 steps: 1- reading the problem, 2-brain storming about the problem, 3- determining and prioritizing the learning topics, 4- searching and collecting the information and 5- sharing and merging the information and would be presented during 4 two-hour sessions and at the beginning of each session, three scenarios about three hypothetical patients with created ethical conflicts who require midwifery services, will be presented. Then, after 15 minutes of explanation for each case, using brain storming, learning needs would be determined and the required information sources for students will be introduced. At the end, with teacher’s cooperation, the topic will be discussed, concluded and modified.</i_keyword>
      <i_keyword>Interrention2: In the computer simulation group, after preparation of the program, the provided version will be examined by the experts of midwifery and ethics. If approved, it will be applied at the same time as the problem-solving oriented group. Before the intervention, a two-hour workshop will be conducted for introducing the program’s environment to the students. Topics that will be presented to the students at the workshop are: stages of registry, different elements of accessing method and the method of using the program. Also, each participant will be given a username and a password to access the program. This group’s education will be conducted with researcher-made software based on problem-solving and as a computer simulation. The program contains an introduction page, a main page, a menu for selecting the scenario and 6 animated scenarios. The designed ethical scenario will be developed using a 6-step integrated ethical decision-making model (including recognizing the problem, finding the possible solutions, evaluating the solutions, selecting the best solution, applying the decision and evaluating the outcomes of the applied decision). It means that the learner will be asked to choose a problem. Before defining a specific problem, information will be gathered through the system. The questions will be aligned in a way that they will guide the learner toward solving the problem step-by-step. Recommending a replacement option for the learner will be provided by</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Decision-making skills in the face of professional ethical conflicts. Timepoint: Before the intervention, one week after the intervention, one month after intervention. Method of measurement: Researcher-made questionnaire based on the Nursing Dilemma Test questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The level of satisfaction with the educational methods. Timepoint: Right after the intervention. Method of measurement: Researcher-made questionnaire.</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>Vice Chancellor for reserch of Mashhad University of Medical Scien</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-09-28</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical sciences</contact_name>
        <contact_address>Street University-School of Medicine Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
