<?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>IRCT2015113025300N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-01-05</date_registration>
      <primary_sponsor>Vice chancellor for research, Kerman  University of Medical Sciences</primary_sponsor>
      <public_title>Telescopic coated dental needles vs. conventional syringe system: comparing pain and anxiety in patients</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trial comparing the effects of standard dental needles and telescopic needles to reduce the pain and anxiety of patients who refer to the dental clinic in Kerman city</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21188</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Pain &amp; Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, patients were injected by new telescopic needle that covered the needle appearance during injection, and also by using lidocaine gel before needle insertion, it has the ability to reduce the pain and anxiety during injection . Intervention 2: In the control group conventional and  standard needles were used , and the pain and anxiety induced in this group examined  with pain and anxiety questionnaire.</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>Dr. Raha HabibAgahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kosar BLVD.</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 34 3213 3440</telephone>
        <email>raha2979@yahoo.com</email>
        <affiliation>Dental and Oral Research Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Maryam Hashemippor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shafa street</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 34 3213 3440</telephone>
        <email>raha2979@yahoo.com</email>
        <affiliation>Kerman Dental School</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: the need for similar dental treatment under local anesthesia (restoration of  teeth number D and E in children and teeth number of 6,7 in  adults); Ability to speak and communicate with the audience; The lack of any developmental delay; The lack of a specific systemic disease; patients do not have pain when entering the study ; Patients in the 48 hours before the dental work are not analgesics. &#13;
&#13;
Exclusion criteria: patients with speech problems and lack the ability to communicate with the audience; Patients with systemic problem;  Single-parent's children ; Patients with a history of dental pain.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F40, F41, </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Neurotic, stress-related and somatoform disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, patients were injected by new telescopic needle that covered the needle appearance during injection, and also by using lidocaine gel before needle insertion, it has the ability to reduce the pain and anxiety during injection .</i_keyword>
      <i_keyword>In the control group conventional and  standard needles were used , and the pain and anxiety induced in this group examined  with pain and anxiety questionnaire.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: After injection. Method of measurement: Visual Analouge Scale (VAS).</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before and after of injection. Method of measurement: Venham's anxiety scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The intrest of patients to refer for later dental procedures. Timepoint: After first dental injecton and treatment. Method of measurement: Questionair.</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>Vice chancellor for research, Kerman  University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-11-23</approval_date>
        <contact_name>Ethics Committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Tahmasbabad Square Kerman  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
