<?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>IRCT20201001048893N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-09</date_registration>
      <primary_sponsor>the center in the National Center for Strategic Research in Medical Education</primary_sponsor>
      <public_title>Assessment of the effectiveness of intelligent simulator of effective communication with the patient on self-efficacy, satisfaction, and caring behavior of nursing students</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effectiveness of intelligent simulator of effective communication with the patient on self-efficacy, satisfaction, and caring behavior of nursing students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60703</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this research project, nursing students will be randomly divided into two groups of intervention and control on the first day of internship in the psychiatric ward, immediately before entering the ward by a person outside the study. In this way, the numbers of all the groups are thrown into a container in the form of folded papers (the number of which cannot be seen) and then an out-of-study person is asked to take half of the folded papers out of the container by chance. The extracted papers will form the intervention group. Since students enter different wards of Ibn Sina Psychiatric Hospital in Shiraz in different groups, in order to prevent data contamination, instead of randomizing students in the intervention and control groups, the whole group will be a randomization unit, so that half The groups will be randomly assigned to the intervention group and the other half to the experimental group (cluster randomization), Blinding description: In this study, in order to blind and prevent possible bias, dividing the groups into two groups, distributing and collecting questionnaires, interpreting the questionnaire, entering and interpreting the data and analyzing the information in statistical software will be done with the help of researchers and statistical experts outside the study. In addition, the data analyst will be unaware of the grouping of students.</study_design>
      <phase>N/A</phase>
      <hc_freetext>.</hc_freetext>
      <i_freetext>This intervention is an interactive communication program and scenarios will be designed in which the user plays the role of a nurse and communicates with the virtual patients. In this program, three scenarios will be designed for each of the depressive, bipolar and schizophrenic diseases. The simulator program includes interacting with virtual patients and receiving appropriate feedback. Scenarios in which the user plays the role of a nurse and communicates with virtual patients will be created in such a way that the users of the program will choose the answer that they consider appropriate for that situation. After logging in, the user interacts with virtual patients in various clinical situations. The user selects an appropriate answer from the multiple-choice questions during the interaction and receives feedback on its correctness or incorrectness. The correct answer will be reminded if the user's response is incorrect. A total of 5 to 10 nurse-patient communication skills will be designed for each scenario. In this study, the students of the intervention group will interact with virtual patients through a simulator in the assembly hall of the hospital before entering the environment of the psychiatric ward. The duration of using the simulator will be decided after its design and based on the opinion of psychiatric nursing professors..</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Anonymous study data will be shared in correspondence with the project manager

When:
Access period starts 6 months after the results are published

To whom:
Researchers working in academic and scientific institutions

Conditions:
Systematic reviews and meta-analyses

Where to obtain:
Contact via email:
m2620.shaygan@gmail.com

How to obtain:
After obtaining permission from the security unit and the university's vice chancellor for research, the data will be made available to the individual.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Shaygan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran, Shiraz, Namazi Square, Namazi Teaching Hospital, Fatemeh PBUH School of Nursing and Midwifery, Building 3, 2nd Floor, Community-based Psychiatric Care Research Center</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13119–71936</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>m2620.shaygan@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Shaygan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran, Shiraz, Namazi Square, Namazi Teaching Hospital, Fatemeh PBUH School of Nursing and Midwifery, Building 3, 2nd Floor, Community-based Psychiatric Care Research Center</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71936-13119</zip>
        <telephone>+98 71 3367 4254</telephone>
        <email>m2620.shaygan@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be a 6th-semester undergraduate student of Hazrat Fatemeh School of Nursing and Midwifery in Shiraz.
Willingness to participate in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Impossibility or withdrawal of the student from continuing to participate in the research at any stage of the study
Having previous experience communicating with a patient with a mental disorder</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>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>This intervention is an interactive communication program and scenarios will be designed in which the user plays the role of a nurse and communicates with the virtual patients. In this program, three scenarios will be designed for each of the depressive, bipolar and schizophrenic diseases. The simulator program includes interacting with virtual patients and receiving appropriate feedback. Scenarios in which the user plays the role of a nurse and communicates with virtual patients will be created in such a way that the users of the program will choose the answer that they consider appropriate for that situation. After logging in, the user interacts with virtual patients in various clinical situations. The user selects an appropriate answer from the multiple-choice questions during the interaction and receives feedback on its correctness or incorrectness. The correct answer will be reminded if the user's response is incorrect. A total of 5 to 10 nurse-patient communication skills will be designed for each scenario. In this study, the students of the intervention group will interact with virtual patients through a simulator in the assembly hall of the hospital before entering the environment of the psychiatric ward. The duration of using the simulator will be decided after its design and based on the opinion of psychiatric nursing professors.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-efficacy. Timepoint: Immediately before and after the intervention. Method of measurement: The Clinical Self-Efficacy Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Satisfaction. Timepoint: Immediately after the intervention. Method of measurement: The Client Satisfaction Questionnaire (CSQ-I).</sec_outcome>
      <sec_outcome>Caring behaviors. Timepoint: Immediately before and after the intervention. Method of measurement: Wolf Nurse Care Behavior Inventory (CBI-42).</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Shiraz University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>the center in the National Center for Strategic Research in Medical Education</source_name>
      <source_name>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-27</approval_date>
        <contact_name>Ethics committee of the center in the National Center for Strategic Research in Medical Education</contact_name>
        <contact_address>No. 65, Saeedi St., Valiasr St., after Ayatollah Hashemi Rafsanjani Highway (former Niayesh). Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
