<?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>IRCT2014052417821N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-11-09</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences Deputy of Research</primary_sponsor>
      <public_title>Nursing ethics education impact on the moral sensitivity and reasoning of nursing students</public_title>
      <acronym>nursing ethics education</acronym>
      <scientific_title>Comparison between impacts of two methods of teaching ethics, lectures and learning based on problem-solving, on students' moral sensitivity and reasoning in Hamadan University of Medical Sciences</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16309</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Other.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ethics in nursing students.</hc_freetext>
      <i_freetext>In this study, senior students of a 4-year nursing program, based on drawing, are divided into two classes of lecture and problem-based learning (PBL). Then nursing ethics education programs include definitions of ethics, ethics areas of study, importance of ethics in nursing, nursing ethics principles and their definition (autonomy, confidentiality, accountability, etc.), professional ethics, codes of nursing ethics, approaches to ethical decision making and ethical decision-making process are developed. Contents of both education program are the same; except in lecture method scenarios (newborn with anomalies, Terminally ill adult, forcing medication, medication error, new nurse orientation, adult’s request to die) are solved by the educator; but in PBL class, students solve the problem based on educated steps of  mixed nursing process pattern  and problem-based learning. Education time for the lecture class was two 4-hour sessions and for PBL class four 2-hour sessions. First, goals, intervention method and appraisal procedure were presented for both classes. Before beginning of the course, Both classes were assessed using research tools including standard moral Sensitivity questionnaire and nursing moral reasoning questionnaire.  For PBL class, first, goals and methods of education based on problem-solving were explained and students were divided into groups of 6-7. In first 2 hours of course for both classes, ethics content presented by researcher as lecture. Then, for lecture class, ethical scenarios were presented and solved by researcher. In PBL class, an advisor selected for each group, and the students were asked to solve the scenarios in a week according to following steps: step1: providing the students with copies of scenarios. Step2: Identifying and understanding the problem and determining ambiguous and unintelligible words. Step3: analyzing and clearly describing the problem and designing methodology questions of the problem (brainstorming). Step4: questions were categorized according to their subjects. Step5: Setting objectives and priorities. Step6: gathering information. Step7: Existing solutions were written based on findings and were rated based on meeting the objectives. At the end of the training sessions, both classes were assessed using post-test and after a month the test was repeated..</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>Seyede Nayereh Falahan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamedan- Pajouhesh square- Shahid Fahmideh Boulevard- Hamedan University of Medical Sciences -school of nursing and midwifery</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 81 3837 1986</telephone>
        <email>nfalahan92@gmail.comn.falahiyan@umsha.ac.ir</email>
        <affiliation>Hamadan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roya Amini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamedan- Pajouhesh square- Shahid Fahmide Boulevard- Hamedan University of Medical Sciences- school of nursing</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>65167</zip>
        <telephone>+98 81 3838 0150</telephone>
        <email>AminiRoy@gmail.comr.amini@umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria  Student should be in internship period (semester seven and eight);  Student should not have passed nursing ethics course; Students must consent (either formally or informally) to participate in sessions.&#13;
Exclusion criteria:  Failure to attend training sessions; Having missed more than one session.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In this study, senior students of a 4-year nursing program, based on drawing, are divided into two classes of lecture and problem-based learning (PBL). Then nursing ethics education programs include definitions of ethics, ethics areas of study, importance of ethics in nursing, nursing ethics principles and their definition (autonomy, confidentiality, accountability, etc.), professional ethics, codes of nursing ethics, approaches to ethical decision making and ethical decision-making process are developed. Contents of both education program are the same; except in lecture method scenarios (newborn with anomalies, Terminally ill adult, forcing medication, medication error, new nurse orientation, adult’s request to die) are solved by the educator; but in PBL class, students solve the problem based on educated steps of  mixed nursing process pattern  and problem-based learning. Education time for the lecture class was two 4-hour sessions and for PBL class four 2-hour sessions. First, goals, intervention method and appraisal procedure were presented for both classes. Before beginning of the course, Both classes were assessed using research tools including standard moral Sensitivity questionnaire and nursing moral reasoning questionnaire.  For PBL class, first, goals and methods of education based on problem-solving were explained and students were divided into groups of 6-7. In first 2 hours of course for both classes, ethics content presented by researcher as lecture. Then, for lecture class, ethical scenarios were presented and solved by researcher. In PBL class, an advisor selected for each group, and the students were asked to solve the scenarios in a week according to following steps: step1: providing the students with copies of scenarios. Step2: Identifying and understanding the problem and determining ambiguous and unintelligible words. Step3: analyzing and clearly describing the problem and designing methodology questions of the problem (brainstorming). Step4: questions were categorized according to their subjects. Step5: Setting objectives and priorities. Step6: gathering information. Step7: Existing solutions were written based on findings and were rated based on meeting the objectives. At the end of the training sessions, both classes were assessed using post-test and after a month the test was repeated.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nursing students’ moral sensitivity- nursing students’ moral reasoning. Timepoint: Pre-education- just after education- one month after education. Method of measurement: Standard questionnaire of nursing students’ moral sensitivity- questionnaire of moral reasoning in nursing.</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>Hamedan University of Medical Sciences Deputy of Research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-05-17</approval_date>
        <contact_name>Hamedan University of Medical Sciences</contact_name>
        <contact_address>Hamedan- Pajouhesh square- Shahid Fahmideh Boulevard- Hamedan University of Medical Sciences Hamedan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
