<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/NCT01718002</url>
  </required_header>
  <id_info>
    <org_study_id>Lab. Comunicação EERP</org_study_id>
    <nct_id>NCT01718002</nct_id>
  </id_info>
  <brief_title>Effect of the Use of Simulation (Video) on the Oral Hygiene</brief_title>
  <official_title>Effect of the Use of Simulation (Video) on the Oral Hygiene of People Undergoing Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The care of the oral cavity is an important way to prevent local and systemic infections.&#xD;
      This study aimed to: evaluate the use of video as a teaching strategy of oral hygiene for&#xD;
      patients undergoing chemotherapy. The methodological design used was quasi-experimental&#xD;
      before-after intervention. The sample consisted of 23 subjects who performed the technique of&#xD;
      oral hygiene before and after watching an educational video. To do so was given a kit with a&#xD;
      toothbrush with soft bristles, toothpaste with low abrasivity, mouthwash or product to&#xD;
      mouthwash and dental floss for oral hygiene. For data analysis we applied the parametric test&#xD;
      t &quot;Student&quot; paired.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      General Purpose Evaluating the use of video as a teaching strategy of oral hygiene for&#xD;
      patients undergoing chemotherapy.&#xD;
&#xD;
      Specific Objectives Assess the steps taken by the subjects to oral hygiene before (initial&#xD;
      performance) and after (final performance) exposure to an educational video on oral hygiene;&#xD;
      To investigate the effect of an educational video on oral hygiene in this clientele; Identify&#xD;
      patient acceptance of the teaching method employed.&#xD;
&#xD;
      Methods and Procedures Delineation The research was quasi-experimental in nature,&#xD;
      before-after intervention (the intervention in this study was the teaching learning strategy&#xD;
      employed used an educational video on oral hygiene.) Patients will be evaluated individually,&#xD;
      before and after exposure to video. It is not foreseen monitoring at other times.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 2011</start_date>
  <completion_date type="Anticipated">November 2012</completion_date>
  <primary_completion_date type="Anticipated">November 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Video as a teaching strategy</measure>
    <time_frame>18/11/2011 to 30/06/2012</time_frame>
    <description>Evaluate the use of video as a teaching strategy of oral hygiene for patients undergoing chemotherapy.&#xD;
The subjects were asked to assign a note about the importance of oral hygiene on a scale of zero to 10.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oral hygiene before (initial performance) and after (final performance) exposure to an educational</measure>
    <time_frame>18/11/2011 to 30/06/2012</time_frame>
    <description>Assess the steps taken by the subjects to oral hygiene before (initial performance) and after (final performance) exposure to an educational video on oral hygiene. The subjects were assessed for scores of hits in 15 steps related to the process of oral hygiene before and after the presentation of educational video. he steps are related to the amount of cream dents, tilt the brush, brushing locations, movements employees, number of repetitions, use of dental floss, mouthwash, among others. Eg: P1 - applied a small amount of toothpaste on the brush; P2 - put the brush bristles inclined in place, between the gum and the tooth, put the brush bristles inclined in place, between the gum and the tooth; P3 - brushed the upper arch with sweeping movements towards the top down; P4 - brushed with the lower jaw movements sweep from top to bottom; P5 - brushed the inside of the teeth gum toward the tip of the tooth, using the movement &quot;sweep &quot;...</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of an educational video</measure>
    <time_frame>18/11/2011 to 30/06/2012</time_frame>
    <description>To investigate the effect of an educational video on oral hygiene in this clientele.&#xD;
As for settling scores of the 15 items assessed (maximum score 15) in the implementation of oral hygiene procedure, the subjects had an average initial phase in the other end. We used the t test &quot;Student&quot; test to detect differences between these averages</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptance of the teaching method</measure>
    <time_frame>18/11/2011 to 30/06/2012</time_frame>
    <description>Identify patient acceptance of the teaching method employed. When the relevance of experience to learn by watching the video, subjects were asked to assign a grade on a scale of zero to 10. From this note will be calculated averages and standard deviation.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>&quot;Hematologic Diseases&quot;</condition>
  <arm_group>
    <arm_group_label>Educational video on oral hygiene</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The patient was asked to execute the technique used daily oral hygiene that, with the sequence, movements and technical procedures for its implementation evaluated and recorded an instrument to analyze the steps of oral hygiene. Subsequently, patients watched the video prepared individually in the ward where they were interned. After this step, the patient demonstrated again the procedure for oral hygiene. At this point the researcher also observed the sequence, movements and technical procedures used to analyze the steps of oral hygiene, using the same instrument for such employee initially.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Educational video</intervention_name>
    <description>The patient was asked to execute the technique used daily oral hygiene that, with the sequence, movements and technical procedures for its implementation evaluated and recorded an instrument to analyze the steps of oral hygiene. Subsequently, patients watched the video prepared individually in the ward where they were interned. After this step, the patient demonstrated again the procedure for oral hygiene. At this point the researcher also observed the sequence, movements and technical procedures used to analyze the steps of oral hygiene, using the same instrument for such employee initially.</description>
    <arm_group_label>Educational video on oral hygiene</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Physical conditions for self-care during the oral hygiene;&#xD;
&#xD;
          -  Score less than or equal to three according to scale performance general condition was&#xD;
             drafted and approved by the American Eastern Cooperative Oncology Group (ECOG)&#xD;
&#xD;
          -  Accept oral diet&#xD;
&#xD;
          -  Lack of nasal catheter or probe nasogastric and nasoenteric&#xD;
&#xD;
          -  Present platelet counts &gt; 20,000 mm3&#xD;
&#xD;
          -  Neutrophils &gt; 1,000 mm3&#xD;
&#xD;
          -  Absence of pathologies or buccal devices which prevent attainment the procedure&#xD;
&#xD;
          -  The presence of teeth&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emilia C Carvalho</last_name>
    <role>Principal Investigator</role>
    <affiliation>Escola de Enfermagem de Ribeirão Preto da Universidade de São Paulo - EERP-USP</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emilia Campos de Carvalho</name>
      <address>
        <city>Ribeirão Preto</city>
        <state>São Paulo</state>
        <zip>14040-902</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>October 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>November 8, 2012</last_update_submitted>
  <last_update_submitted_qc>November 8, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 9, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Emilia Campos de Carvalho</investigator_full_name>
    <investigator_title>Full Professor</investigator_title>
  </responsible_party>
  <keyword>Nursing</keyword>
  <keyword>Simulation</keyword>
  <keyword>Education</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematologic Diseases</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/NCT01718002
org study id: Lab. Comunicação EERP
nct id: NCT01718002
lead sponsor: 
has dmc: Yes
The care of the oral cavity is an important way to prevent local and systemic infections.
      This study aimed to: evaluate the use of video as a teaching strategy of oral hygiene for
      patients undergoing chemotherapy. The methodological design used was quasi-experimental
      before-after intervention. The sample consisted of 23 subjects who performed the technique of
      oral hygiene before and after watching an educational video. To do so was given a kit with a
      toothbrush with soft bristles, toothpaste with low abrasivity, mouthwash or product to
      mouthwash and dental floss for oral hygiene. For data analysis we applied the parametric test
      t "Student" paired.
General Purpose Evaluating the use of video as a teaching strategy of oral hygiene for
      patients undergoing chemotherapy.

      Specific Objectives Assess the steps taken by the subjects to oral hygiene before (initial
      performance) and after (final performance) exposure to an educational video on oral hygiene;
      To investigate the effect of an educational video on oral hygiene in this clientele; Identify
      patient acceptance of the teaching method employed.

      Methods and Procedures Delineation The research was quasi-experimental in nature,
      before-after intervention (the intervention in this study was the teaching learning strategy
      employed used an educational video on oral hygiene.) Patients will be evaluated individually,
      before and after exposure to video. It is not foreseen monitoring at other times.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Video as a teaching strategy
time frame: 18/11/2011 to 30/06/2012
description: Evaluate the use of video as a teaching strategy of oral hygiene for patients undergoing chemotherapy.
The subjects were asked to assign a note about the importance of oral hygiene on a scale of zero to 10.
measure: Oral hygiene before (initial performance) and after (final performance) exposure to an educational
time frame: 18/11/2011 to 30/06/2012
description: Assess the steps taken by the subjects to oral hygiene before (initial performance) and after (final performance) exposure to an educational video on oral hygiene. The subjects were assessed for scores of hits in 15 steps related to the process of oral hygiene before and after the presentation of educational video. he steps are related to the amount of cream dents, tilt the brush, brushing locations, movements employees, number of repetitions, use of dental floss, mouthwash, among others. Eg: P1 - applied a small amount of toothpaste on the brush; P2 - put the brush bristles inclined in place, between the gum and the tooth, put the brush bristles inclined in place, between the gum and the tooth; P3 - brushed the upper arch with sweeping movements towards the top down; P4 - brushed with the lower jaw movements sweep from top to bottom; P5 - brushed the inside of the teeth gum toward the tip of the tooth, using the movement "sweep "...
measure: Effect of an educational video
time frame: 18/11/2011 to 30/06/2012
description: To investigate the effect of an educational video on oral hygiene in this clientele.
As for settling scores of the 15 items assessed (maximum score 15) in the implementation of oral hygiene procedure, the subjects had an average initial phase in the other end. We used the t test "Student" test to detect differences between these averages
measure: Acceptance of the teaching method
time frame: 18/11/2011 to 30/06/2012
description: Identify patient acceptance of the teaching method employed. When the relevance of experience to learn by watching the video, subjects were asked to assign a grade on a scale of zero to 10. From this note will be calculated averages and standard deviation.
arm group label: Educational video on oral hygiene
arm group type: Other
description: The patient was asked to execute the technique used daily oral hygiene that, with the sequence, movements and technical procedures for its implementation evaluated and recorded an instrument to analyze the steps of oral hygiene. Subsequently, patients watched the video prepared individually in the ward where they were interned. After this step, the patient demonstrated again the procedure for oral hygiene. At this point the researcher also observed the sequence, movements and technical procedures used to analyze the steps of oral hygiene, using the same instrument for such employee initially.
intervention type: Behavioral
intervention name: Educational video
description: The patient was asked to execute the technique used daily oral hygiene that, with the sequence, movements and technical procedures for its implementation evaluated and recorded an instrument to analyze the steps of oral hygiene. Subsequently, patients watched the video prepared individually in the ward where they were interned. After this step, the patient demonstrated again the procedure for oral hygiene. At this point the researcher also observed the sequence, movements and technical procedures used to analyze the steps of oral hygiene, using the same instrument for such employee initially.
arm group label: Educational video on oral hygiene
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Emilia C Carvalho
role: Principal Investigator
affiliation: Escola de Enfermagem de Ribeirão Preto da Universidade de São Paulo - EERP-USP
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Emilia Campos de Carvalho
investigator title: Full Professor
mesh term: Hematologic Diseases