<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/NCT04467788</url>
  </required_header>
  <id_info>
    <org_study_id>NSaad</org_study_id>
    <nct_id>NCT04467788</nct_id>
  </id_info>
  <brief_title>Effectiveness of Computer-Aided Versus Clinical Simulation Sessions on Knowledge, Attitude and Practice of Ergonomics</brief_title>
  <official_title>Effectiveness of Computer-Aided Versus Clinical Simulation Sessions on Knowledge, Attitude and Practice of Ergonomics Among A Group of Dental Interns: A Randomized Controlled Trial</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>Yes</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>
      A healthy dentist is one of the most important components of a successful dental practice. It&#xD;
      is estimated that more than half of practitioners have some kind of painful work-related&#xD;
      musculoskeletal disorders.&#xD;
&#xD;
      It was reported that 80% of dental students were not aware of ergonomic posture during dental&#xD;
      procedures. It is believed that dental students with knowledge of ergonomic principals would&#xD;
      be able to maintain their health. Some studies demonstrated that the frequency and severity&#xD;
      of WMSDs might decrease by training the dentists on ergonomic principles.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be carried out on dental interns in Department of Pediatric Dentistry and&#xD;
      Dental Public Health, in Faculty of Dentistry-Cairo University. The procedures will be&#xD;
      carried out by postgraduate student Nourhan Saad Mohamed who has M.D.S. (2018) - Cairo&#xD;
      University- Egypt, and works as Assistant Lecturer in Future University in Egypt. The&#xD;
      procedures will be done without assistant at a lecture room and outpatient clinic of&#xD;
      Pediatric Dentistry in Cairo University.&#xD;
&#xD;
      At baseline, evaluation of knowledge, attitude and practice (KAP) on ergonomics in dentistry&#xD;
      will be do e through a self-structured questionnaire.&#xD;
&#xD;
      Afterwards, the participants will be split into two groups. One group will recieve training&#xD;
      on ergonomic principles through clinical simulation session, while the other group will&#xD;
      recieve training through Computer-aided sessions.&#xD;
&#xD;
      KAP will be re-evaluated after the training sessions to evaluate the change in KAP about&#xD;
      ergonomics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2021</start_date>
  <completion_date type="Anticipated">December 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>KAP questionnaire on ergonomics in dentistry</measure>
    <time_frame>1 questionnaire for 15 minutes before the learning modules</time_frame>
    <description>At baseline, assessment of the knowledge, attitude and practice of dental interns regarding ergonomics in Dentistry will be done before the educational module assigned to each group. The questionnaire will include 25 multiple choice questions, each question will score 4 with the total questionnaire out of 100.&#xD;
The questionnaire that will score 75 or less will considered as failed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in knowledge, attitude &amp; practice of ergonomics after interactive learning about ergonomics in dentistry through computer-aided sessions on ergonomic principles.</measure>
    <time_frame>1 questionnaire (15 minutes) after the computer aided session and another questionnaire (15 minutes)at the end of internship round</time_frame>
    <description>Assessment of the knowledge, attitude and practice of dental interns regarding ergonomics in Dentistry will be done after the educational module assigned to the group. The questionnaire will include 25 multiple choice questions, each question will score 4 with the total questionnaire out of 100.&#xD;
The questionnaire that will score 75 or less will considered as failed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in knowledge, attitude &amp; practice of ergonomics after interactive learning about ergonomics in dentistry through clinical simulation sessions on ergonomic principles</measure>
    <time_frame>1 questionnaire (15 minutes) after the clinical simulation session and another questionnaire (15 minutes)at the end of internship round</time_frame>
    <description>Assessment of the knowledge, attitude and practice of dental interns regarding ergonomics in Dentistry will be done after the educational module assigned to the group. The questionnaire will include 25 multiple choice questions, each question will score 4 with the total questionnaire out of 100.&#xD;
The questionnaire that will score 75 or less will considered as failed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">118</enrollment>
  <condition>Occupational Problems</condition>
  <arm_group>
    <arm_group_label>Computer-aided session</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Training on ergonomic principles in dentistry will be given to the participants through Computer-Aided sessions, including explaining videos on proper postures in dental practice .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinical Simulation Session</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Training on ergonomic principles in dentistry will be given to the participants through clinical simulation sessions showing the proper postures in dental practice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Computer-aided sessions</intervention_name>
    <description>Changing participants' KAP of ergonomics in dentistry</description>
    <arm_group_label>Computer-aided session</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical simulation sessions</intervention_name>
    <description>Changing participants' KAP of ergonomics in dentistry</description>
    <arm_group_label>Clinical Simulation Session</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Dental interns who accept to participate in the study.&#xD;
&#xD;
          -  Graduates of governmental or private dental schools.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Interns with history of chronic musculoskeletal disorders.&#xD;
&#xD;
          -  Interns who perform other physical activities which required forced posture.&#xD;
&#xD;
          -  Interns with history of fracture in the ribs or vertebrae.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Nourhan SM Ali, PhD</last_name>
    <phone>00201277555265</phone>
    <email>Nourhan.saad@dentistry.cu.edu.eg</email>
  </overall_contact>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 11, 2020</last_update_submitted>
  <last_update_submitted_qc>July 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Nourhan Saad Mohamed Ali</investigator_full_name>
    <investigator_title>Assistant Lecturer</investigator_title>
  </responsible_party>
  <keyword>Ergonomics in dentistry</keyword>
  <!-- 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/NCT04467788
org study id: NSaad
nct id: NCT04467788
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A healthy dentist is one of the most important components of a successful dental practice. It
      is estimated that more than half of practitioners have some kind of painful work-related
      musculoskeletal disorders.

      It was reported that 80% of dental students were not aware of ergonomic posture during dental
      procedures. It is believed that dental students with knowledge of ergonomic principals would
      be able to maintain their health. Some studies demonstrated that the frequency and severity
      of WMSDs might decrease by training the dentists on ergonomic principles.
This study will be carried out on dental interns in Department of Pediatric Dentistry and
      Dental Public Health, in Faculty of Dentistry-Cairo University. The procedures will be
      carried out by postgraduate student Nourhan Saad Mohamed who has M.D.S. (2018) - Cairo
      University- Egypt, and works as Assistant Lecturer in Future University in Egypt. The
      procedures will be done without assistant at a lecture room and outpatient clinic of
      Pediatric Dentistry in Cairo University.

      At baseline, evaluation of knowledge, attitude and practice (KAP) on ergonomics in dentistry
      will be do e through a self-structured questionnaire.

      Afterwards, the participants will be split into two groups. One group will recieve training
      on ergonomic principles through clinical simulation session, while the other group will
      recieve training through Computer-aided sessions.

      KAP will be re-evaluated after the training sessions to evaluate the change in KAP about
      ergonomics.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: KAP questionnaire on ergonomics in dentistry
time frame: 1 questionnaire for 15 minutes before the learning modules
description: At baseline, assessment of the knowledge, attitude and practice of dental interns regarding ergonomics in Dentistry will be done before the educational module assigned to each group. The questionnaire will include 25 multiple choice questions, each question will score 4 with the total questionnaire out of 100.
The questionnaire that will score 75 or less will considered as failed.
measure: Change in knowledge, attitude & practice of ergonomics after interactive learning about ergonomics in dentistry through computer-aided sessions on ergonomic principles.
time frame: 1 questionnaire (15 minutes) after the computer aided session and another questionnaire (15 minutes)at the end of internship round
description: Assessment of the knowledge, attitude and practice of dental interns regarding ergonomics in Dentistry will be done after the educational module assigned to the group. The questionnaire will include 25 multiple choice questions, each question will score 4 with the total questionnaire out of 100.
The questionnaire that will score 75 or less will considered as failed.
measure: Change in knowledge, attitude & practice of ergonomics after interactive learning about ergonomics in dentistry through clinical simulation sessions on ergonomic principles
time frame: 1 questionnaire (15 minutes) after the clinical simulation session and another questionnaire (15 minutes)at the end of internship round
description: Assessment of the knowledge, attitude and practice of dental interns regarding ergonomics in Dentistry will be done after the educational module assigned to the group. The questionnaire will include 25 multiple choice questions, each question will score 4 with the total questionnaire out of 100.
The questionnaire that will score 75 or less will considered as failed.
arm group label: Computer-aided session
arm group type: Active Comparator
description: Training on ergonomic principles in dentistry will be given to the participants through Computer-Aided sessions, including explaining videos on proper postures in dental practice .
arm group label: Clinical Simulation Session
arm group type: Active Comparator
description: Training on ergonomic principles in dentistry will be given to the participants through clinical simulation sessions showing the proper postures in dental practice.
intervention type: Other
intervention name: Computer-aided sessions
description: Changing participants' KAP of ergonomics in dentistry
arm group label: Computer-aided session
intervention type: Other
intervention name: Clinical simulation sessions
description: Changing participants' KAP of ergonomics in dentistry
arm group label: Clinical Simulation Session
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nourhan SM Ali, PhD
phone: 00201277555265
email: Nourhan.saad@dentistry.cu.edu.eg
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Nourhan Saad Mohamed Ali
investigator title: Assistant Lecturer