<?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>IRCT20220131053897N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-29</date_registration>
      <primary_sponsor>Jahrom University of Medical Sciences</primary_sponsor>
      <public_title>The effect of personal protective equipment on physiological indicators and fatigue</public_title>
      <acronym></acronym>
      <scientific_title>The effect of corona personal protective equipment (PPE) on physiological  indicators and Fatigue of nursing Intern  students after cardiopulmonary resuscitation(CPCR)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62781</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sampling of nursing students in the 8th semester will be done by census method. The list of students was prepared from the nursing faculty education unit, according to the conditions of entry into the study and based on the announcement of students' readiness to participate in the study, which was made after the call. Each student was assigned a code that These numbers were randomly selected using Excel software and random data generation, and by entering these codes in the random allocation software, they will be assigned to the intervention (20 people) and control (20 people) groups by the statistical consultant, Blinding description: In this study, due to the nature of the study, it is not possible to blind the participants, but the data collector and data analyst will be blinded and will not know how to allocate people to two groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Comparison of physiological indices and students' fatigue index after cardiopulmonary resuscitation with and without personal protective equipment..</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group:" In this group, 20 nursing intern students enter the clinical skills center of the nursing faculty in the form of groups of two. In the beginning, physiological indicators, including systolic and diaphragmatic blood pressure, heart rate, arterial blood saturation, and Borg's fatigue score are expressed by the group members. He performs basic cardiopulmonary resuscitation for 12 minutes, changing the position of two people every 2 minutes. After the recovery, the physiological indicators and the specified number are measured and recorded by the researchers. Intervention 2: Control group: "Control group:" In this group, 20 nursing intern students enter the clinical skills center of the nursing faculty in the form of groups of two. At first, physiological indicators including systolic and diastolic blood pressure, heart rate, arterial blood oxygen saturation and oral temperature are taken by the researcher, and the Borg fatigue score is expressed by the group members. They perform cardiopulmonary resuscitation exactly like the intervention group. Immediately after recovery, the physiological indicators and the fatigue index score are measured and recorded again by the researcher.</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:
All the individual data of the participants in the intervention groups and the control group, including demographic, biometric, and anthropometric information, after making the individuals unidentifiable by the researcher, can be published in the form of a thesis, printed article, and full and detailed information by accessing the researcher's email can be received.

When:
The access period starts 3 months after the results are published in the form of theses and articles.

To whom:
The data of this study will be available for researchers working in academic and scientific institutions and people working in the field of nursing.

Conditions:
Applicants use this data after coordination with the researcher and for the purpose of use in the fields of medicine, nursing, sports physiology and with the consent for any analysis on the data required by the applicant.

Where to obtain:
In order to receive the desired documents and data, the applicant can refer to the website of Jahrom University of Medical Sciences at the address /www.jums.ac.ir and enter the title of the thesis and the name of the researcher or via the e-mail of the researcher academy at the address S.Tavan@jums. ac.ir can access the information by contacting the researcher.

How to obtain:
The applicant can access the researcher's email three months after the publication of the article by visiting the website of  Jahrom University of Medical Sciences and searching for the name of the researcher and the article, or send an email directly to the researcher's email address that is registered on the article, and if the researcher approves, it is complete. The information will be made available to him after making it unidentifiable.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>SaharTavan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alamdar Alley 11,AlamdarKarbalaSt,Fatemieh Town</address>
        <city>Jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7411475997</zip>
        <telephone>+98 71 5433 9605</telephone>
        <email>S.Tavan@jums.ac.ir</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>SaharTavan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alamdar Alley 11,AlamdarKarbalaSt,Fatemieh Town</address>
        <city>Jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>741147</zip>
        <telephone>009854339605</telephone>
        <email>S.Tavan@jums.ac.ir</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>No history of respiratory diseases and heart disorders
Body mass index 18 to 30
Not participating in regular and professional sports activities
Passing the theoretical and practical unit of cardiopulmonary resuscitation in accordance with the educational curriculum of the field of nursing
Resting heart rate greater than 50 beats per minute or less than 120 beats per minute
At rest, oxygen saturation is more than 95%
Resting breathing rate should be more than 10 or less than 20 beats per minute
Do not have Covid 19 disease or have no symptoms at the time of the study
Do not recover from Covid 19
Absence of pregnancy or menstruation in women at the time of the study
Age 21 to 30 years</inclusion_criteria>
      <agemin>21 years</agemin>
      <agemax>30 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Students who did not pass the 7th nursing semester.
Lack of access to participant prior to randomization</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>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Intervention group:" In this group, 20 nursing intern students enter the clinical skills center of the nursing faculty in the form of groups of two. In the beginning, physiological indicators, including systolic and diaphragmatic blood pressure, heart rate, arterial blood saturation, and Borg's fatigue score are expressed by the group members. He performs basic cardiopulmonary resuscitation for 12 minutes, changing the position of two people every 2 minutes. After the recovery, the physiological indicators and the specified number are measured and recorded by the researchers.</i_keyword>
      <i_keyword>Control group: "Control group:" In this group, 20 nursing intern students enter the clinical skills center of the nursing faculty in the form of groups of two. At first, physiological indicators including systolic and diastolic blood pressure, heart rate, arterial blood oxygen saturation and oral temperature are taken by the researcher, and the Borg fatigue score is expressed by the group members. They perform cardiopulmonary resuscitation exactly like the intervention group. Immediately after recovery, the physiological indicators and the fatigue index score are measured and recorded again by the researcher.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fatigue score in Borg cr10 questionnaire. Timepoint: At the beginning of the study (before the start of cardiopulmonary resuscitation) and 12 minutes after the start of resuscitation in both intervention and control groups. Method of measurement: Pressure Borg CR10 Perception Scale Questionnaire.</prim_outcome>
      <prim_outcome>Blood pressure score in mm Hg. Timepoint: At the beginning of the study (before the start of cardiopulmonary resuscitation) and 12 minutes after the start of resuscitation in both intervention and control groups. Method of measurement: Tensval digital blood pressure checker comfort model.</prim_outcome>
      <prim_outcome>Arterial blood oxygen saturation percentage. Timepoint: At the beginning of the study (before the start of cardiopulmonary resuscitation) and 12 minutes after the start of resuscitation in both intervention and control groups. Method of measurement: New model blood oxygen check machine (onix Vantage).</prim_outcome>
      <prim_outcome>The number of heartbeats per minute. Timepoint: At the beginning of the study (before the start of cardiopulmonary resuscitation) and 12 minutes after the start of resuscitation in both intervention and control groups. Method of measurement: Tensval digital blood pressure checker comfort model.</prim_outcome>
      <prim_outcome>Degree of oral fever. Timepoint: At the beginning of the study (before the start of cardiopulmonary resuscitation) and 12 minutes after the start of resuscitation in both intervention and control groups. Method of measurement: Imperial digital thermometer model 301.</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>Jahrom University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-15</approval_date>
        <contact_name>Ethics committee ofJahrom University of Medical Sciences</contact_name>
        <contact_address>Pardis site- Jahrom University of Medical Sciences -- after the Nursing Faculty-- Ostad Motahari St-Jahrom Jahrom Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
