<?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>IRCT20240608062038N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-06-18</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Comparing virtual and real simulators of the operating room environment for managing nursing students' self-confidence and anxiety in the first experience of operating room</public_title>
      <acronym></acronym>
      <scientific_title>Comparing virtual and real simulators of the operating room environment for managing nursing students' self-confidence and anxiety in the first experience of operating room</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77359</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Education of students.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: After explaining the objectives of the research and obtaining consent from the participants, the students of both the control and intervention groups will complete the study questionnaires. Then the training in the intervention group will be done in a virtual way. In the intervention group, the training is based on the use of virtual simulation (virtual tour of the operating room), which will be provided to them via mobile phone two days before entering the operating room, and the students will familiarize themselves with the operating room environment through the simulator. will interact. After the educational interventions, the students of both the intervention and control groups enter the real operating room and perform their routine tasks in the internship. At the end of the first day, both groups will complete the study questionnaires. Finally, on the last day of the study, the questionnaires of this study will be completed again by the students of both groups. Intervention 2: Control group:  After explaining the objectives of the research and obtaining consent from the participants, the students of both the control and intervention groups will complete the study questionnaires. Then the training will be done in the control group based on the usual method and in the intervention group in a virtual method. In this way, two days before entering the operating room, the students of the control group, by attending the practical environment (real simulation) according to the usual routine, receive the necessary explanations about the environment of the operating room and the relevant rules from their professor. After the educational interventions, the students of both the intervention and control groups enter the real operating room and perform their routine tasks in the internship. At the end of the first day, both groups will complete the study questionnaires. Finally, on the last day of the study, the questionnaires of this study will be completed again by the students of both groups.</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:
1- Obtaining the code of ethics from the Research Vice-Chancellor of Shiraz University of Medical Sciences 2- Obtaining a letter of introduction from the Research Vice-Chancellor of Shiraz University of Medical Sciences and presenting it to the Educational Vice-Chancellor of Shiraz University of Medical Sciences 3- Providing an explanation to all research units about the objectives and how to implement it 4- Obtaining informed consent at the beginning of the study from the research units 5- Keeping in mind the willingness of the research units to participate in the research and informing them about the possibility of withdrawing at any stage of the study without any penalty or impact on their academic evaluation 6- Reassuring the research units that the information obtained is confidential and only general results will be published 7- Respecting the rights of colleagues in all publications resulting from this research 8- Adhering to the principles of Helsinki ethics

When:
The storage period of study data is about two years.

To whom:
Research units

Conditions:
If the research participants request to know their educational status

Where to obtain:
Executive in charge of the research project

How to obtain:
The contact number and email of the responsible executive will be provided to the participants.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehdi Hasanshahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Namazi square - Faculty of Nursing</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71936-13119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>mhdi.hasanshahi@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Hasanshahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Namazi square - Faculty of Nursing</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71936-13119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>mhdi.hasanshahi@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Nursing undergraduate students
Choosing a study unit in the field of adults 1
Student of Hazrat Fatemeh (S) Faculty of Nursing and Midwifery, Shiraz
Willingness to participate in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having previous experience of being in the operating room environment</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: After explaining the objectives of the research and obtaining consent from the participants, the students of both the control and intervention groups will complete the study questionnaires. Then the training in the intervention group will be done in a virtual way. In the intervention group, the training is based on the use of virtual simulation (virtual tour of the operating room), which will be provided to them via mobile phone two days before entering the operating room, and the students will familiarize themselves with the operating room environment through the simulator. will interact. After the educational interventions, the students of both the intervention and control groups enter the real operating room and perform their routine tasks in the internship. At the end of the first day, both groups will complete the study questionnaires. Finally, on the last day of the study, the questionnaires of this study will be completed again by the students of both groups.</i_keyword>
      <i_keyword>Control group:  After explaining the objectives of the research and obtaining consent from the participants, the students of both the control and intervention groups will complete the study questionnaires. Then the training will be done in the control group based on the usual method and in the intervention group in a virtual method. In this way, two days before entering the operating room, the students of the control group, by attending the practical environment (real simulation) according to the usual routine, receive the necessary explanations about the environment of the operating room and the relevant rules from their professor. After the educational interventions, the students of both the intervention and control groups enter the real operating room and perform their routine tasks in the internship. At the end of the first day, both groups will complete the study questionnaires. Finally, on the last day of the study, the questionnaires of this study will be completed again by the students of both groups.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-confidence. Timepoint: Before the start of training - the first day of training - the end of training. Method of measurement: Rosenberg self-esteem scale.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before the start of training - the first day of training - the end of training. Method of measurement: Spielberger anxiety questionnaire.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-03-11</approval_date>
        <contact_name>Faculties of nursing and midwifery, management and medical information - Shiraz University of Medica</contact_name>
        <contact_address>Namazi square- Faculty of Nursing Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
