<?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>IRCT20230814059140N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-23</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of using a standard patient and video training in teaching the level of consciousness to students</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of standard patient-based training and video training on the skill of measuring the level of consciousness among nursing students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72032</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Students were randomly assigned to two study groups using the Rand Between command in Excel.</study_design>
      <phase>N/A</phase>
      <hc_freetext>.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: the standard patient was used. The standard patient education and standardization process included four stages and six face-to-face sessions. Four people acted as standard patients, who were selected from nursing students without any medical background. 2 hours of their training, including explaining the study objectives; standard patient performance assessment; Designing a simulation scenario and then executing the scenario by the patient was standard. The participants were divided into three groups of 11-12 people in order to have a suitable ratio of students to instructors. After teaching the basics of theory with PowerPoint, for the practical part, the training was conducted in the clinical skills center with the help of a standard patient. This training process was carried out in one hour. In this way, the first 30 minutes of the session were considered to remind the rules related to interaction with the standard patient and the goals of the session and to review the training of GCS measurement skills by the trainer with the help of the standard patient, 20 minutes of the session for practice by the participants and 10 minutes of questions. , response, feedback and bug fixes were considered. It should be noted that during the practice, the standard patient was asked to perform the response based on the pre-designed scenario so that the students would get familiar with the scoring items. The professor stood next to the bed and started checking with a standard patient. 5 stations and 5 examiners were present at this stage. One standard patient and one examiner were present at each station, which consisted of 4 practical stations, one written station, and 4 scenarios. In the fifth station, three written level questions Vigilance was answered by the examiners. The assessment of the skill level was through the OSCE test. Intervention 2: Control group: After teaching the basics of theory by presenting PowerPoint, The training video was prepared in such a way that the professor stood next to the bed and started checking motor responses with a standard patient; Verbally and visually. And it was broadcasted to groups of 11 students. In addition, three scenarios were prepared and implemented for students to practice, which included visual, verbal and movement responses in each scenario. After showing the prepared video about how to check the level of consciousness of the patients, the scenarios were shown to the students and they were asked to write down their answers on the sheet. Then one of the student volunteers was asked to explain his answer to the others.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Faezeh Soltanian Telkabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>In front of the infertility research center ؛ Bo Ali St.,  Timsar Falahi St.</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916978477</zip>
        <telephone>+98 35 3824 1751</telephone>
        <email>soltanianfaezeh2020@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mostafa Javadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>In front of the infertility research centerBu Ali St ., Timsar Falahi St.</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916978477</zip>
        <telephone>+98 35 3824 1751</telephone>
        <email>javadinurse@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Students who have passed 80% of the dedicated units according to the timetable of the Faculty of Nursing and Midwifery
Students are willing to participate in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Failure to participate in a similar training course in the past year</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>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: the standard patient was used. The standard patient education and standardization process included four stages and six face-to-face sessions. Four people acted as standard patients, who were selected from nursing students without any medical background. 2 hours of their training, including explaining the study objectives; standard patient performance assessment; Designing a simulation scenario and then executing the scenario by the patient was standard. The participants were divided into three groups of 11-12 people in order to have a suitable ratio of students to instructors. After teaching the basics of theory with PowerPoint, for the practical part, the training was conducted in the clinical skills center with the help of a standard patient. This training process was carried out in one hour. In this way, the first 30 minutes of the session were considered to remind the rules related to interaction with the standard patient and the goals of the session and to review the training of GCS measurement skills by the trainer with the help of the standard patient, 20 minutes of the session for practice by the participants and 10 minutes of questions. , response, feedback and bug fixes were considered. It should be noted that during the practice, the standard patient was asked to perform the response based on the pre-designed scenario so that the students would get familiar with the scoring items. The professor stood next to the bed and started checking with a standard patient. 5 stations and 5 examiners were present at this stage. One standard patient and one examiner were present at each station, which consisted of 4 practical stations, one written station, and 4 scenarios. In the fifth station, three written level questions Vigilance was answered by the examiners. The assessment of the skill level was through the OSCE test</i_keyword>
      <i_keyword>Control group: After teaching the basics of theory by presenting PowerPoint, The training video was prepared in such a way that the professor stood next to the bed and started checking motor responses with a standard patient; Verbally and visually. And it was broadcasted to groups of 11 students. In addition, three scenarios were prepared and implemented for students to practice, which included visual, verbal and movement responses in each scenario. After showing the prepared video about how to check the level of consciousness of the patients, the scenarios were shown to the students and they were asked to write down their answers on the sheet. Then one of the student volunteers was asked to explain his answer to the others.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The skill of measuring the level of consciousness. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: OSCE exam.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-09</approval_date>
        <contact_name>Ethics Committee of Shahid Sadoughi University of Yazd</contact_name>
        <contact_address>Central Building of Shahid Sadougi University of Medical Sciences , Yazd Bahonar Square Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
