<?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>IRCT20161007030193N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-28</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Comparison the effect of  hypnosis,nitrous oxide and conventional behavior guidance on anxiety level of school-age children during local anesthesia injection and dental extraction</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of  hypnosis,nitrous oxide and conventional behavior guidance on anxiety level of school-age children during local anesthesia injection and dental extraction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35736</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study the participants divided into three groups  by block randomization method by use of web program "randomizer.org".</study_design>
      <phase>3</phase>
      <hc_freetext>Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: participants who were  hypnotized during local anesthesia injection and dental extraction.The hypnosis intervention included a standard 3-minute progressive muscle relaxation induction followed by a 5-minute deepening procedure aimed at increasing the patients’ focus, absorption, and concentration. In the intervention phase the hypnotic suggestions were aimed at modifying their perception of pain. Intervention 2: Intervention group 2:  participants who were  sedated by nitrous oxide  during local anesthesia injection and dental extraction. At first  introduction of 100 percent oxygen for  two minutes followed by titration of nitrous oxide in 10 percent intervals up to 40% concentration of nitous oxide to achieve ideal sedation.After local anesthesia injection and dental extraction. the nitrous oxide flow is terminated, 100 percent oxygen should be delivered for five minutes. Intervention 3: Control group:  participants who were  managed during local anesthesia injection and dental extraction by conventional behavior guidance such as Tell Show Do technique and roll modeling and voice control method.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Data are available among corresponding author

When:
After publication of the article

To whom:
Every one who needs for scientific aims such as researchers who work on systematic review
projects

Conditions:
For research aims by formal request

Where to obtain:
Contact with corresponding author by e-mail address

How to obtain:
After discussion the authors decide to accept or reject the request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Iman Parisay</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad Dental Faculty-Vakil Abbad BLVD</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948959</zip>
        <telephone>+98 51 3882 9501</telephone>
        <email>parisayi@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Iman Parisay</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad Dental Faculty-Vakil Abbad BLVD</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948959</zip>
        <telephone>+98 51 3882 9501</telephone>
        <email>parisayi@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>7-11 year-old school-aged children
Having mild to moderate anxiety
Having no chronic systemic diseases
Having no mental retardation and autism
Having no history of dental  treatment with hypnosis or nitrous oxide
Having primary molar candidate for extraction</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>11 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Uncooperative patient
Not hypnosis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F93.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Phobic anxiety disorder of childhood</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: participants who were  hypnotized during local anesthesia injection and dental extraction.The hypnosis intervention included a standard 3-minute progressive muscle relaxation induction followed by a 5-minute deepening procedure aimed at increasing the patients’ focus, absorption, and concentration. In the intervention phase the hypnotic suggestions were aimed at modifying their perception of pain.</i_keyword>
      <i_keyword>Intervention group 2:  participants who were  sedated by nitrous oxide  during local anesthesia injection and dental extraction. At first  introduction of 100 percent oxygen for  two minutes followed by titration of nitrous oxide in 10 percent intervals up to 40% concentration of nitous oxide to achieve ideal sedation.After local anesthesia injection and dental extraction. the nitrous oxide flow is terminated, 100 percent oxygen should be delivered for five minutes</i_keyword>
      <i_keyword>Control group:  participants who were  managed during local anesthesia injection and dental extraction by conventional behavior guidance such as Tell Show Do technique and roll modeling and voice control method</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety level. Timepoint: before local anesthesia injection-during  local anesthesia injection- during dental extraction. Method of measurement: Venham Clinical Anxiety and Cooperation Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Heart rate. Timepoint: Before local anesthesia injection, during local anesthesia injection, during dental extraction. Method of measurement: Pulsoximetre.</sec_outcome>
      <sec_outcome>Oxygen saturation. Timepoint: Before local anesthesia injection, during local anesthesia injection, during dental extraction. Method of measurement: Pulsoximetre.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-13</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Mashhad Dental Faculty, Vakil Abbad Blvd Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
