<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/NCT04438148</url>
  </required_header>
  <id_info>
    <org_study_id>x643gvu9</org_study_id>
    <nct_id>NCT04438148</nct_id>
  </id_info>
  <brief_title>Prevalence and Effect of Workplace Stress Among Pediatric Dentists</brief_title>
  <official_title>Prevalence and Effect of Workplace Stress Among Pediatric Dentists</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      Work-related stress is a pattern of physiological, emotional, cognitive and behavioural&#xD;
      reactions to some extremely taxing aspects of work content, work organization and work&#xD;
      environment.&#xD;
&#xD;
      Certain work situations are too intense and frequent in nature that exceed an individual's&#xD;
      coping capabilities and resources to handle them adequately Dentistry is commonly known as a&#xD;
      stressful profession among various occupations. Frequent dealing with different types of&#xD;
      patients, working in a very small area for long period of time , exposure to toxic substances&#xD;
      , all these factors put the dentist under stress.&#xD;
&#xD;
      Adding to the previous factors, working to uncooperative children with annoying parents, will&#xD;
      put pediatric dentistry on the top of the most stressful branches in dentistry.&#xD;
&#xD;
      Stress can affect pedodontists physiologically by increasing their blood pressure, heart&#xD;
      rate, breathing rate and excessive sweating which in turn may increase the risk of&#xD;
      hypertension and breathing problems.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All Paricipants were informed about the objectives of the study and signed an informed&#xD;
      consent before participating in the study.&#xD;
&#xD;
      On the day of work, blood pressure and heart rate will be measured for every pediatric&#xD;
      dentist at the beginning of the day before starting any case and will be measured again after&#xD;
      3 hours from continuous work. Then, the two readings will be recorded and compared. This part&#xD;
      will help in the physiological assessment of the study.&#xD;
&#xD;
      The psychological part will be assessed by asking the pediatric dentists to answer the&#xD;
      questions of the 2 scales. {Appendices (2 &amp;3)}&#xD;
&#xD;
      There will be a specially designed chart for fulfilling the aim of the study designed by the&#xD;
      main investigator, this recording chart is formulated to collect the data from the&#xD;
      participants.&#xD;
&#xD;
      The recording chart is composed of 3 sections:&#xD;
&#xD;
      The First Section includes sociodemographic data The Second Section includes psychological&#xD;
      assessment in which the score gets by each participant is recorded.&#xD;
&#xD;
      The Third Section includes physiological assessment in which the first and second readings of&#xD;
      heart rate and blood pressure are recorded and inspected for any change.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">September 30, 2020</start_date>
  <completion_date type="Anticipated">July 2022</completion_date>
  <primary_completion_date type="Actual">September 30, 2021</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of stress</measure>
    <time_frame>6 months</time_frame>
    <description>Cohen percieved stress scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Degree of stress</measure>
    <time_frame>6 months</time_frame>
    <description>Workplace stress scale</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Heart rate</measure>
    <time_frame>6 months</time_frame>
    <description>Digital sphygmamanometer</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood Pressure systolic and diastolic</measure>
    <time_frame>6 months</time_frame>
    <description>Digital sphygmamanometer</description>
  </other_outcome>
  <enrollment type="Anticipated">246</enrollment>
  <condition>Workplace Stress</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Postgraduate pediatric dentists aged from 25 to 40 years old, medically free&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Both genders are included&#xD;
&#xD;
          -  Postgraduate dentists submitting for master and PHD in pediatric dentistry&#xD;
&#xD;
          -  Medically free&#xD;
&#xD;
          -  The participants who sign the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants taking drugs affecting nervous system&#xD;
&#xD;
          -  Fasting participants&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maha Sayed, BSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Resident at pediatric dentistry and dental public health department</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shaimaa Sabry, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Lecturer at pediatric dentistry and dental public health department</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Walaa Fakher, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Lecturer of Psychiatry, Faculty of Medicine, Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Randa Youssif, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Associate Professer at Pediatric dentistry and dental public health department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <state>El Manial</state>
        <zip>11562</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 30, 2022</last_update_submitted>
  <last_update_submitted_qc>June 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Maha Sayed</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Occupational Stress</mesh_term>
  </condition_browse>
  <!-- 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/NCT04438148
org study id: x643gvu9
nct id: NCT04438148
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Work-related stress is a pattern of physiological, emotional, cognitive and behavioural
      reactions to some extremely taxing aspects of work content, work organization and work
      environment.

      Certain work situations are too intense and frequent in nature that exceed an individual's
      coping capabilities and resources to handle them adequately Dentistry is commonly known as a
      stressful profession among various occupations. Frequent dealing with different types of
      patients, working in a very small area for long period of time , exposure to toxic substances
      , all these factors put the dentist under stress.

      Adding to the previous factors, working to uncooperative children with annoying parents, will
      put pediatric dentistry on the top of the most stressful branches in dentistry.

      Stress can affect pedodontists physiologically by increasing their blood pressure, heart
      rate, breathing rate and excessive sweating which in turn may increase the risk of
      hypertension and breathing problems.
All Paricipants were informed about the objectives of the study and signed an informed
      consent before participating in the study.

      On the day of work, blood pressure and heart rate will be measured for every pediatric
      dentist at the beginning of the day before starting any case and will be measured again after
      3 hours from continuous work. Then, the two readings will be recorded and compared. This part
      will help in the physiological assessment of the study.

      The psychological part will be assessed by asking the pediatric dentists to answer the
      questions of the 2 scales. {Appendices (2 &3)}

      There will be a specially designed chart for fulfilling the aim of the study designed by the
      main investigator, this recording chart is formulated to collect the data from the
      participants.

      The recording chart is composed of 3 sections:

      The First Section includes sociodemographic data The Second Section includes psychological
      assessment in which the score gets by each participant is recorded.

      The Third Section includes physiological assessment in which the first and second readings of
      heart rate and blood pressure are recorded and inspected for any change.
observational model: Other
time perspective: Cross-Sectional
measure: Prevalence of stress
time frame: 6 months
description: Cohen percieved stress scale
measure: Degree of stress
time frame: 6 months
description: Workplace stress scale
measure: Heart rate
time frame: 6 months
description: Digital sphygmamanometer
measure: Blood Pressure systolic and diastolic
time frame: 6 months
description: Digital sphygmamanometer
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 25 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maha Sayed, BSc
role: Principal Investigator
affiliation: Resident at pediatric dentistry and dental public health department
last name: Shaimaa Sabry, PhD
role: Study Chair
affiliation: Lecturer at pediatric dentistry and dental public health department
last name: Walaa Fakher, PhD
role: Study Chair
affiliation: Lecturer of Psychiatry, Faculty of Medicine, Cairo University
last name: Randa Youssif, PhD
role: Study Director
affiliation: Associate Professer at Pediatric dentistry and dental public health department
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Maha Sayed
investigator title: Principle investigator
mesh term: Occupational Stress