<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT201511223168N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-04-26</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences Vice chancellor for research</primary_sponsor>
      <public_title>Effect of coping skill training on pain perception, anxiety and behavior in dentistry</public_title>
      <acronym></acronym>
      <scientific_title>Effect of coping skill training versus no coping training on  pain perception, anxiety and behavior in 3-6 years old children during dental treatment as a clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3211</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Using the website: www.randomizer.org.</study_design>
      <phase>N/A</phase>
      <hc_freetext>dental anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention1: 45 patients in first visit received dental prophylaxis or fluoride therapy using Tell-Show-Do technique. In second visit before dental procedure they will receive coping skill training including deep breathing, silence time, muscle relaxation and releasing anxious thoughts in about 20 minutes. Training these skills will be done by a pediatric dentistry resident. Pain perception, anxiety and behavior in first and second visit will be measured by a resident of pediatric dentistry who is blinded to study. Intervention 2: Intervention2: 45 patients in first visit received dental prophylaxis or fluoride therapy using Tell-Show-Do technique. In second visit they will receive routine dental procedure without any coping training. Pain perception, anxiety and behavior in first and second visit will be measured by a resident of pediatric dentistry who is blinded to study.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Samiei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz University of Medical Siceinces, Daneshgah Square, Abresan st.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 3335 5967</telephone>
        <email>Samiei.moh@gmail.com</email>
        <affiliation>Tabriz Dental Faculty</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Erfanprast</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz University of Medical Siceinces, Daneshgah Square, Abresan st.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 3335 5967</telephone>
        <email>erfanparastl@tbzmed.ac.ir</email>
        <affiliation>Tabriz Dental Faculty</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 3-6 year old children, attending to Department of Pediatric Dentistry of Tabriz University of Medical Sciences, who has at least one carious primary mandibular molar, needing inferior alveolar nerve block, physical and psychological health according to SDQ (strengths and difficulties questionnaires) test. Exclusion criteria: children under 3 and above 6 year old, children who have physical or psychological disorder, history of hospitalization, history of major medical or dental procedures, history of dental pain and history of stress disorders.</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>6 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention1: 45 patients in first visit received dental prophylaxis or fluoride therapy using Tell-Show-Do technique. In second visit before dental procedure they will receive coping skill training including deep breathing, silence time, muscle relaxation and releasing anxious thoughts in about 20 minutes. Training these skills will be done by a pediatric dentistry resident. Pain perception, anxiety and behavior in first and second visit will be measured by a resident of pediatric dentistry who is blinded to study.</i_keyword>
      <i_keyword>Intervention2: 45 patients in first visit received dental prophylaxis or fluoride therapy using Tell-Show-Do technique. In second visit they will receive routine dental procedure without any coping training. Pain perception, anxiety and behavior in first and second visit will be measured by a resident of pediatric dentistry who is blinded to study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain perception. Timepoint: before and immediately after intervention. Method of measurement: Wong baker faces pain rating scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anxiety. Timepoint: before and immediately after intervention. Method of measurement: venham anxiety rating scale.</sec_outcome>
      <sec_outcome>Behavior. Timepoint: before and immediately after intervention. Method of measurement: frankle scale.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tabriz University of Medical Sciences Vice chancellor for research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-11-09</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Science</contact_name>
        <contact_address>Tabriz University of Medical Siceinces, Daneshgah Square, Abresan st. Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
