<?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>IRCT20230306057638N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-08-15</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of narrative medicine education in nursing students</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of narrative medicine education (through the lens of nursing) on self-compassion and understanding the dimensions of care in nursing students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78521</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Students admitted to the Bachelor of Nursing program for the academic year 1403 (2024) will be divided into two relatively balanced classes, A and B, upon their initial enrollment at the university. This division will be based on the arrangement of the school, and the research team will adhere to the guidelines established by the esteemed educational unit.

The allocation of individuals to intervention and control groups will be conducted through simple randomization in three stages:
1. First Stage of Randomization: The assignment of intervention/control to classes A and B will be determined by a coin toss. (Rationale: This is to reduce the exposure of students in the intervention groups to those in the control groups.)
2. Second Stage: Thirty students from each group, A and B, will be randomly selected independently. (In total, 60 students will be involved, but the groups will not be mixed.) (Rationale: This ensures that all students from classes A and B can potentially participate in the study.)
3. Third Stage: Each of the selected students from groups A and B, whose allocation to intervention and control groups has now been determined, will be randomly divided into groups of 8 to 12 for clinical training in the hospital. (In this stage, due to the importance of fostering a friendly atmosphere in team-based clinical education, efforts will be made to accommodate student preferences as much as possible.)

Gender balance (male/female) will be maintained throughout all stages of randomization, Blinding description: Due to the educational nature of the study, only the statistical analyst will be blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Internship will take place in the internal-surgery departments of hospitals, focusing on patients with internal and surgical issues..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The main theoretical topics of the intervention group training will include: What is narrative medicine? (Origins and sources of narrative medicine, filling the gaps in healthcare, characteristics of narrative in medical sciences), the stories of illnesses (recounting life stories, patient-body-self), development of narrative competencies (close reading, attention-representation-dependence, parallel diagrams), and the benefits of narrative medicine (testifying, bioethical considerations in narrative medicine, narrative perspectives for healthcare). Initially, theoretical concepts will be explored using methods such as brainstorming and flipped classrooms. This will be followed by practical training through role-playing, observation and critique of related films and literature, group discussions, team-based learning, and scenario-based training. Finally, education will take place at the bedside of patients. The goal is to practice and learn the application of narrative medicine and its components in relation to real patients. To foster intimacy and create a pleasant educational atmosphere while avoiding monotony, diverse teaching methods will be employed, alongside additional strategies such as learning cafés or working breakfasts. It is understood that short-term feedback will be provided to students during clinical exercises. Assessment will be cumulative and progressive, with instruction conducted by both the supervising instructor and the researcher (student). Intervention 2: Control group:  In the control group, trained instructors will be responsible for conducting the training according to the routine lesson plan of the school. In all groups of the control group, a pre-test will be administered at the beginning of the first day of the internship, and a post-test will be completed by the end of the tenth day.</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 additional information available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Negin Farid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Intersection of Valiasr St. and Niayesh Highway, in front of Rajaei Hospital, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996835119</zip>
        <telephone>0989120061201</telephone>
        <email>n.farid@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fariba Borhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Intersection of Valiasr St. and Niayesh Highway, in front of Rajaei Hospital, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996835119</zip>
        <telephone>+98 21 8820 2511</telephone>
        <email>Faribaborhani47@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ability to communicate in Persian.
Taking the course on Principles and Skills of Nursing (theoretical and practical) and the related internship for the first time in course selection (without prior experience in course completion).</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Students who have had or currently have any duration of experience in clinical therapeutic work.
Students who, after the initiation of the research process, refuse to complete the questionnaires at any stage or complete them incompletely.
Students who completed fewer than 9 out of 10 internship shifts in the hospital due to justified or unjustified absences.
Students who change their major, or resign from their academic program during their course of study.
Students who pass away during their course of study.</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The main theoretical topics of the intervention group training will include: What is narrative medicine? (Origins and sources of narrative medicine, filling the gaps in healthcare, characteristics of narrative in medical sciences), the stories of illnesses (recounting life stories, patient-body-self), development of narrative competencies (close reading, attention-representation-dependence, parallel diagrams), and the benefits of narrative medicine (testifying, bioethical considerations in narrative medicine, narrative perspectives for healthcare). Initially, theoretical concepts will be explored using methods such as brainstorming and flipped classrooms. This will be followed by practical training through role-playing, observation and critique of related films and literature, group discussions, team-based learning, and scenario-based training. Finally, education will take place at the bedside of patients. The goal is to practice and learn the application of narrative medicine and its components in relation to real patients. To foster intimacy and create a pleasant educational atmosphere while avoiding monotony, diverse teaching methods will be employed, alongside additional strategies such as learning cafés or working breakfasts. It is understood that short-term feedback will be provided to students during clinical exercises. Assessment will be cumulative and progressive, with instruction conducted by both the supervising instructor and the researcher (student).</i_keyword>
      <i_keyword>Control group:  In the control group, trained instructors will be responsible for conducting the training according to the routine lesson plan of the school. In all groups of the control group, a pre-test will be administered at the beginning of the first day of the internship, and a post-test will be completed by the end of the tenth day.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-compassion. Timepoint: Before the intervention, after the end of the tenth (last) internship shift. Method of measurement: Neff self-compassion questionnaire (2003).</prim_outcome>
      <prim_outcome>Caring Dimensions Inventory. Timepoint: Before the intervention, after the end of the tenth (last) internship shift. Method of measurement: Caring Dimensions Inventory-35: CDI-35_Watson.</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>2024-08-05</approval_date>
        <contact_name>Research Ethics Committees of School of Pharmacy and Nursing &amp; Midwifery- Shahid Beheshti University</contact_name>
        <contact_address>Intersection of Valiasr St. and Niayesh Highway, in front of Rajaei Hospital, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
