<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04473547</url>
  </required_header>
  <id_info>
    <org_study_id>p.0203</org_study_id>
    <nct_id>NCT04473547</nct_id>
  </id_info>
  <brief_title>COVID 19 Preventive Measures Among Mansoura Nursing Students</brief_title>
  <official_title>Adherence of Nursing Students to Preventive Measures Towards Coronavirus Disease 19 During Written Exams</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to identify nursing students knowledge gaps, risk perceptions and adherence&#xD;
      to COVID 19 preventive measures during written exam period and In addition due to the&#xD;
      possibility of being infected with COVID-19 during exams this study will evaluate covid-19&#xD;
      symptoms rate during exam period and factors affecting its development .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As of june,27,2020, Egypt lift most COVID-19 restrictions and government decided to held&#xD;
      written exams for final year students with precautionary measures. Students reported fears&#xD;
      regarding the possibility of being infected during exams period and want to postpone or&#xD;
      cancel exams due to possible contact during transportation and meeting in classes. Education&#xD;
      have been provided to population in general and students in special through social media,&#xD;
      social networks, community leaders to take precautionary measures during exams.&#xD;
&#xD;
      Studies provide support for the notion of increased vulnerability to respiratory tract&#xD;
      infections with exposure to psychological stress . one of specific stress is Academic Exam&#xD;
      stress that has been linked with immuno-suppression.&#xD;
&#xD;
      Exams are stressful experience and a place for student gathering , moreover there is no&#xD;
      research about adherence level or factors affecting adherence to COVID-19 precautions among&#xD;
      nursing students during exam period. Nursing students are future professionals who can&#xD;
      address new emerging infectious diseases.&#xD;
&#xD;
      the study aims to analyze students adherence to COVID 19 preventive measures and to to&#xD;
      identify the knowledge gaps, risk perceptions and factors affecting students adherence which&#xD;
      could guide the design of better nursing education curricula regarding COVID-19 as a&#xD;
      preparation for final year nursing students to internship year which will be on September&#xD;
      2020 . In addition due to the possibility of being infected with COVID-19 during exams or&#xD;
      during their internship year this study will evaluate covid-19 symptoms rate during exam&#xD;
      period and factors affecting its development .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 10, 2020</start_date>
  <completion_date type="Actual">February 15, 2021</completion_date>
  <primary_completion_date type="Actual">August 20, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>adherence level to coronavirus disease 19 preventive measures among nursing students during written exams.</measure>
    <time_frame>from 15\7\2020 to 1\8\2020</time_frame>
    <description>an online questionnaire consists of six sections as following (hand hygiene practices, social distancing, respiratory hygiene, social distancing, cleaning and disinfection and nurse role model. Each item will be answered as &quot;always&quot; or &quot;sometimes&quot; or &quot; rarely&quot; or &quot;never&quot; .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>number of students who develop possible covid-19 symptoms during written exams</measure>
    <time_frame>longitudinal over 6 weeks from 15\7\2020 to 30\8\2020</time_frame>
    <description>Online questionnaire will be sent to students every 2 weeks for 6 weeks (during and after exam period by two weeks )asking about the appearance of new symptoms of COVID-19 including ( fever, dry cough, shortness of breath, new loss of taste or smell, muscle pain, …) every two weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Eye,nose,mouth,Face and mask touch frequency during written exams</measure>
    <time_frame>from 15\7\2020 to 1\8\2020</time_frame>
    <description>students will be videotaped during exams and analyzed using observational checklist for hand to eye , nose, mouth, mask and face touch frequency</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>nursing students knowledge level of COVID 19</measure>
    <time_frame>from 15\7\2020 to 30\8\2020</time_frame>
    <description>A correct answer will be scored (1) while incorrect or missed answer will be scored (0). The level of knowledge will be considered poor if the percentage mean score is less than 50%, fair if from 50 to less than 75%, and good if more than or equal 75% .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>COVID 19 risk perception level among nursing students undergoing written exams</measure>
    <time_frame>from 15\7\2020 to 30\8\2020</time_frame>
    <description>Each item will be answered as &quot;no&quot; (0) or &quot;not sure&quot; (1) or&quot; yes&quot; (2). A high score meant a high risk perception.</description>
  </secondary_outcome>
  <enrollment type="Actual">144</enrollment>
  <condition>Covid19</condition>
  <eligibility>
    <study_pop>
      <textblock>
        A convenient sample of 215 4th level 2nd term bachelor nursing students undergoing written&#xD;
        exam in July period and agree to participate in study will be involved. The target&#xD;
        population are 484 students who are undergoing written exam this year. The required sample&#xD;
        size was calculated by Raosoft sample size calculator. Based on the estimated population&#xD;
        and response distribution of 50%, the required sample size is 215 with a confidence level&#xD;
        of 95% and 5% margin of error.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Students who agree to participate.&#xD;
&#xD;
          -  Students of both gender .&#xD;
&#xD;
          -  Students who have access to internet and have whatsapp account&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Students diagnosed with COVID-19 before.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Nursing Mansoura University</name>
      <address>
        <city>Mansoura</city>
        <zip>35511</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>March 4, 2021</last_update_submitted>
  <last_update_submitted_qc>March 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>mohamed elsayed hamed elzeky</investigator_full_name>
    <investigator_title>lecturer-medical surgical nursing department-faculty of nursing mansoura university</investigator_title>
  </responsible_party>
  <keyword>COVID 19</keyword>
  <keyword>preventive measures</keyword>
  <keyword>nursing students</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04473547
org study id: p.0203
nct id: NCT04473547
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to identify nursing students knowledge gaps, risk perceptions and adherence
      to COVID 19 preventive measures during written exam period and In addition due to the
      possibility of being infected with COVID-19 during exams this study will evaluate covid-19
      symptoms rate during exam period and factors affecting its development .
As of june,27,2020, Egypt lift most COVID-19 restrictions and government decided to held
      written exams for final year students with precautionary measures. Students reported fears
      regarding the possibility of being infected during exams period and want to postpone or
      cancel exams due to possible contact during transportation and meeting in classes. Education
      have been provided to population in general and students in special through social media,
      social networks, community leaders to take precautionary measures during exams.

      Studies provide support for the notion of increased vulnerability to respiratory tract
      infections with exposure to psychological stress . one of specific stress is Academic Exam
      stress that has been linked with immuno-suppression.

      Exams are stressful experience and a place for student gathering , moreover there is no
      research about adherence level or factors affecting adherence to COVID-19 precautions among
      nursing students during exam period. Nursing students are future professionals who can
      address new emerging infectious diseases.

      the study aims to analyze students adherence to COVID 19 preventive measures and to to
      identify the knowledge gaps, risk perceptions and factors affecting students adherence which
      could guide the design of better nursing education curricula regarding COVID-19 as a
      preparation for final year nursing students to internship year which will be on September
      2020 . In addition due to the possibility of being infected with COVID-19 during exams or
      during their internship year this study will evaluate covid-19 symptoms rate during exam
      period and factors affecting its development .
observational model: Other
time perspective: Prospective
measure: adherence level to coronavirus disease 19 preventive measures among nursing students during written exams.
time frame: from 15\7\2020 to 1\8\2020
description: an online questionnaire consists of six sections as following (hand hygiene practices, social distancing, respiratory hygiene, social distancing, cleaning and disinfection and nurse role model. Each item will be answered as "always" or "sometimes" or " rarely" or "never" .
measure: number of students who develop possible covid-19 symptoms during written exams
time frame: longitudinal over 6 weeks from 15\7\2020 to 30\8\2020
description: Online questionnaire will be sent to students every 2 weeks for 6 weeks (during and after exam period by two weeks )asking about the appearance of new symptoms of COVID-19 including ( fever, dry cough, shortness of breath, new loss of taste or smell, muscle pain, …) every two weeks.
measure: Eye,nose,mouth,Face and mask touch frequency during written exams
time frame: from 15\7\2020 to 1\8\2020
description: students will be videotaped during exams and analyzed using observational checklist for hand to eye , nose, mouth, mask and face touch frequency
measure: nursing students knowledge level of COVID 19
time frame: from 15\7\2020 to 30\8\2020
description: A correct answer will be scored (1) while incorrect or missed answer will be scored (0). The level of knowledge will be considered poor if the percentage mean score is less than 50%, fair if from 50 to less than 75%, and good if more than or equal 75% .
measure: COVID 19 risk perception level among nursing students undergoing written exams
time frame: from 15\7\2020 to 30\8\2020
description: Each item will be answered as "no" (0) or "not sure" (1) or" yes" (2). A high score meant a high risk perception.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: mohamed elsayed hamed elzeky
investigator title: lecturer-medical surgical nursing department-faculty of nursing mansoura university
mesh term: COVID-19
sharing ipd: Undecided