<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/NCT03247959</url>
  </required_header>
  <id_info>
    <org_study_id>IGIDSIRB2016NDP27PGSKPPD</org_study_id>
    <nct_id>NCT03247959</nct_id>
  </id_info>
  <brief_title>Effectiveness of Active and Passive Distraction Techniques on Reducing Fear and Anxiety and Improving Oral Health Knowledge of Children Undergoing Extraction in the Dental Operatory- A Randomized Controlled Trial</brief_title>
  <official_title>Effectiveness of Active and Passive Distraction Techniques on Reducing Fear and Anxiety and Improving Oral Health Knowledge of Children Undergoing Extraction in the Dental Operatory - A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indira Gandhi Institute of Dental Science</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indira Gandhi Institute of Dental Science</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>
      The Purpose of this study is to evaluate the effectiveness of active ( video game) and&#xD;
      passive (video) distraction techniques on reducing fear and anxiety and improving oral health&#xD;
      knowledge of children undergoing extraction in the dental operatory&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dentists are expected to identify and effectively treat childhood dental diseases that are&#xD;
      within the knowledge and skills acquired during their dental education. As every child is&#xD;
      different, safe and effective treatment of oral diseases often requires modifying the child's&#xD;
      behavior. Behavior guidance involves interaction of the dentist and dental team, the patient&#xD;
      and the parent directed towards communication and education. Its goal is to ease fear and&#xD;
      anxiety while promoting an understanding of the need for good oral health.&#xD;
&#xD;
      In 1936, Freud defined Anxiety as an unpleasant affective state or condition, which is&#xD;
      characterized by all that is covered by the word 'nervousness' and it can be prevented by the&#xD;
      avoidance of negative experiences and promotion of positive experiences in children attending&#xD;
      the dental operatory.&#xD;
&#xD;
      In Pediatric dentistry, communicative management and appropriate use of commands have been&#xD;
      used in both cooperative and uncooperative child.Commonly used techniques associated with&#xD;
      this guiding process are tell-show-do, voice control, nonverbal communication, positive&#xD;
      reinforcement and physical restraints. Even though these techniques decrease the perception&#xD;
      of unpleasantness, avert negative behaviours, gain or maintain the patient's attention and&#xD;
      compliance, it is impossible for pediatric dentists to divert their attention from perceiving&#xD;
      pain during invasive dental procedures.&#xD;
&#xD;
      American Academy of Pediatric Dentistry (2008) described distraction as a technique of&#xD;
      diverting the patient's attention from what may be perceived as an unpleasant procedure.&#xD;
      According to McCaul and Malott, one must attend to the pain stimulus in order to perceive it&#xD;
      and also experience the associated distress. Thus distraction might help in reducing the pain&#xD;
      perception. As the individual's attentional capacity is finite, a distracting task that&#xD;
      requires a great deal of the person's attentional resources should leave little attentional&#xD;
      capacity available for processing painful stimuli.&#xD;
&#xD;
      Thus, highly engaging and interactive distraction activities that involve multiple sensory&#xD;
      systems are likely to be more effective than more passive distractors or distracters that&#xD;
      involve only one or two sensory systems. A number of recent distraction interventions for&#xD;
      acute pain in children and adolescents have employed virtual reality (VR) technology in&#xD;
      conjunction with either a passive distraction stimulus, such as a movie (Sullivan, Schneider,&#xD;
      Musselman, Dummett, &amp; Gardiner, 2000), or an interactive distraction activity, such as a&#xD;
      computer game (Dahlquist et al., 2007). However, the actual benefit of VR technology over and&#xD;
      above the benefits of the distracting stimulus that is experienced through the VR equipment&#xD;
      has not been adequately tested in children.&#xD;
&#xD;
      It is observed from the literature review that only few studies were found on virtual reality&#xD;
      distraction and their findings suggest that virtual reality can enhance the effects of&#xD;
      distraction for some children and thus demands further research.&#xD;
&#xD;
      Dental problems in children occur due to their poor oral health knowledge and difficulty of&#xD;
      parents in implementing healthy oral habits for their children at home. Thus in order to&#xD;
      promote oral health knowledge, method of delivering it should be effective. Till date only&#xD;
      one study has focused on educating oral health through video game, thus investigators planned&#xD;
      this study on videogames as videogames has got extreme potential and is a favourite time pass&#xD;
      for children nowadays. The videogame/ video are the interactive tools which would help&#xD;
      educate children in a playful way. Hence this study is planned to compare three behaviour&#xD;
      guiding techniques (active distraction using videogames, passive distraction using video and&#xD;
      verbatim (verbal distraction) in children( participants) for guiding their behavior during&#xD;
      dental procedure in a dental operatory. All these three techniques utilize instructions&#xD;
      related to oral health. In addition to that, investigators have planned to assess whether&#xD;
      these distraction techniques could effectively deliver Oral Health Education to children (&#xD;
      participants).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 3, 2017</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction in fear during the treatment</measure>
    <time_frame>30 minutes</time_frame>
    <description>Fear will be assessed before, during and after the treatment by assessing the participants pulse rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reduction in anxiety during the treatment</measure>
    <time_frame>30 minutes</time_frame>
    <description>Anxiety will be assessed by using chotta-bheem chutki anxiety scale before, during and after the treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in Oral health knowledge</measure>
    <time_frame>1 week</time_frame>
    <description>oral health education related questionnaire will be given to the participants before the treatment to assess the baseline measure and knowledge will be assessed again after 1 week</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">114</enrollment>
  <condition>Fear Anxiety</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group A: Videogame distraction during extraction procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group B: Video distraction during extraction procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>group C: Verbatim during extraction procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Video game distraction and video distraction</intervention_name>
    <description>video game distraction and video distraction will be advocated during the extraction procedure</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Children aged 6-12yrs&#xD;
&#xD;
          2. Children requiring simple extraction ( Primary teeth with preshedding mobility)&#xD;
&#xD;
          3. Children requiring Infiltration LA only&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Children below 6 yrs and above 12 yrs&#xD;
&#xD;
          2. Children with special health care needs&#xD;
&#xD;
          3. Children requiring complicated extraction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Swarna Kannan, Postgraduate</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indira gandhi institute of dental sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Swarna Kannan</last_name>
    <phone>8760833345</phone>
    <email>dentistswarna@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>kayalvizhi Gurusamy, MDS</last_name>
    <phone>9886120559</phone>
    <email>drfisheyes@yahoo.co.in</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Swarna</name>
      <address>
        <city>Puducherry</city>
        <state>Pondicherry</state>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Swarna kannan, postgraduate</last_name>
      <phone>8760833345</phone>
      <email>dentistswarna@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Kayalvizhi Gurusamy, MDS</last_name>
      <phone>9886120559</phone>
      <email>drfisheyes@yahoo.co.in</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>August 9, 2017</last_update_submitted>
  <last_update_submitted_qc>August 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indira Gandhi Institute of Dental Science</investigator_affiliation>
    <investigator_full_name>Swarna Kannan</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>oral health education, distraction, videogame</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</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/NCT03247959
org study id: IGIDSIRB2016NDP27PGSKPPD
nct id: NCT03247959
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The Purpose of this study is to evaluate the effectiveness of active ( video game) and
      passive (video) distraction techniques on reducing fear and anxiety and improving oral health
      knowledge of children undergoing extraction in the dental operatory
Dentists are expected to identify and effectively treat childhood dental diseases that are
      within the knowledge and skills acquired during their dental education. As every child is
      different, safe and effective treatment of oral diseases often requires modifying the child's
      behavior. Behavior guidance involves interaction of the dentist and dental team, the patient
      and the parent directed towards communication and education. Its goal is to ease fear and
      anxiety while promoting an understanding of the need for good oral health.

      In 1936, Freud defined Anxiety as an unpleasant affective state or condition, which is
      characterized by all that is covered by the word 'nervousness' and it can be prevented by the
      avoidance of negative experiences and promotion of positive experiences in children attending
      the dental operatory.

      In Pediatric dentistry, communicative management and appropriate use of commands have been
      used in both cooperative and uncooperative child.Commonly used techniques associated with
      this guiding process are tell-show-do, voice control, nonverbal communication, positive
      reinforcement and physical restraints. Even though these techniques decrease the perception
      of unpleasantness, avert negative behaviours, gain or maintain the patient's attention and
      compliance, it is impossible for pediatric dentists to divert their attention from perceiving
      pain during invasive dental procedures.

      American Academy of Pediatric Dentistry (2008) described distraction as a technique of
      diverting the patient's attention from what may be perceived as an unpleasant procedure.
      According to McCaul and Malott, one must attend to the pain stimulus in order to perceive it
      and also experience the associated distress. Thus distraction might help in reducing the pain
      perception. As the individual's attentional capacity is finite, a distracting task that
      requires a great deal of the person's attentional resources should leave little attentional
      capacity available for processing painful stimuli.

      Thus, highly engaging and interactive distraction activities that involve multiple sensory
      systems are likely to be more effective than more passive distractors or distracters that
      involve only one or two sensory systems. A number of recent distraction interventions for
      acute pain in children and adolescents have employed virtual reality (VR) technology in
      conjunction with either a passive distraction stimulus, such as a movie (Sullivan, Schneider,
      Musselman, Dummett, & Gardiner, 2000), or an interactive distraction activity, such as a
      computer game (Dahlquist et al., 2007). However, the actual benefit of VR technology over and
      above the benefits of the distracting stimulus that is experienced through the VR equipment
      has not been adequately tested in children.

      It is observed from the literature review that only few studies were found on virtual reality
      distraction and their findings suggest that virtual reality can enhance the effects of
      distraction for some children and thus demands further research.

      Dental problems in children occur due to their poor oral health knowledge and difficulty of
      parents in implementing healthy oral habits for their children at home. Thus in order to
      promote oral health knowledge, method of delivering it should be effective. Till date only
      one study has focused on educating oral health through video game, thus investigators planned
      this study on videogames as videogames has got extreme potential and is a favourite time pass
      for children nowadays. The videogame/ video are the interactive tools which would help
      educate children in a playful way. Hence this study is planned to compare three behaviour
      guiding techniques (active distraction using videogames, passive distraction using video and
      verbatim (verbal distraction) in children( participants) for guiding their behavior during
      dental procedure in a dental operatory. All these three techniques utilize instructions
      related to oral health. In addition to that, investigators have planned to assess whether
      these distraction techniques could effectively deliver Oral Health Education to children (
      participants).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Reduction in fear during the treatment
time frame: 30 minutes
description: Fear will be assessed before, during and after the treatment by assessing the participants pulse rate
measure: Reduction in anxiety during the treatment
time frame: 30 minutes
description: Anxiety will be assessed by using chotta-bheem chutki anxiety scale before, during and after the treatment
measure: Improvement in Oral health knowledge
time frame: 1 week
description: oral health education related questionnaire will be given to the participants before the treatment to assess the baseline measure and knowledge will be assessed again after 1 week
arm group label: Group A
arm group type: Experimental
description: Group A: Videogame distraction during extraction procedure
arm group label: Group B
arm group type: Experimental
description: Group B: Video distraction during extraction procedure
arm group label: Group C
arm group type: Active Comparator
description: group C: Verbatim during extraction procedure
intervention type: Behavioral
intervention name: Video game distraction and video distraction
description: video game distraction and video distraction will be advocated during the extraction procedure
arm group label: Group A
arm group label: Group B
arm group label: Group C
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: No
last name: Swarna Kannan, Postgraduate
role: Principal Investigator
affiliation: Indira gandhi institute of dental sciences
last name: Swarna Kannan
phone: 8760833345
email: dentistswarna@gmail.com
last name: kayalvizhi Gurusamy, MDS
phone: 9886120559
email: drfisheyes@yahoo.co.in
facility: 
status: Recruiting
contact: 
contact backup: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Indira Gandhi Institute of Dental Science
investigator full name: Swarna Kannan
investigator title: Principal investigator
mesh term: Anxiety Disorders
sharing ipd: Undecided