<?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>IRCT20190505043473N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-06-27</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of the effectiveness of"ACT"and"CBT"on dental anxiety</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of acceptance and commitment therapy and cognitive-behavioral therapy on dental anxiety, cognitive emotion regulation and oral health-related quality of life in patients with dental anxiety</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39271</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Individual randomization will be implemented by blinded statistician, using the block randomization method and black concealed pocket, Blinding description: participants, Evaluators and statistical consultant Will be unaware of the type of intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Dental anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Therapy based on acceptance and commitment: This treatment approach has six central processes that ultimately lead to psychological flexibility. These processes include acceptance, cognitive discontinuity, self as the background, relationship with the present time, values, and committed action . In this research, therapy based on acceptance and commitment will be implemented in 10 sessions (90 minutes each) using a treatment package (Haze, 2016). Intervention 2: Intervention group: Cognitive-Behavioral Therapy: A kind of psychotherapy that helps patients to reach thoughts and feelings that affect their behavior. The cognitive-behavioral training and therapeutic sessions refer to sessions that will be conducted for at least 10 sessions (90 minutes each), during which cognitive-behavioral techniques will be taught using cognitive-behavioral therapy for anxiety and dental phobias package(Ost, Öst, &amp; Skaret, 2013). Intervention 3: Control group: Control group will not receive any treatment during the study period , However, after the end of the research, the intervention will be done for them, free of charge.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is there are not more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham sadat Binandeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No19, No 3 alley, Baborahme Ave ,Isfahan Town</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8136644443</zip>
        <telephone>+98 31 3792 5512</telephone>
        <email>binandeh@mail.mui.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elham sadat Binandeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No19, No 3 alley, Baborahme Ave.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8136644443</zip>
        <telephone>+98 31 3792 5512</telephone>
        <email>binandeh@mail.mui.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People living in Isfahan
age between 19-50 years old
higher education level than middle school
Willingness to attend intervention sessions and giving written consent
minimum physical and cognitive abilities for participating in psychological interventions
Supplementary studying of psychiatric criteria using SCL-90-R self-report questionnaire
Having the dental anxiety using Stouthard dental anxiety Inventory
Having at least 20 natural teeth
Additional confirmation of dental anxiety will report by pulse oximeters by a dentist. Heart rate of each patient will be measured after relaxing for 5 minutes in the waiting room for 2 times.Then it will be measured twice during the dental treatment, and the mean values will be compared.If  the second measure was at least 5 beats per minute higher than the first one, the patient will participate in the study
Having at least one treated teeth</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>systemic diseases or congenital syndromes approved by an internal specialist
sensation of pain byVAS (score higher than1)
psychiatric disorders except dental anxiety according to DSM-5 criteria
need for emergent dental care approved by a dentist
Graduated in any fields of dentistry and psychology
receiving psychiatric therapies and chemical drugs in the last six months</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>Other</i_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Therapy based on acceptance and commitment: This treatment approach has six central processes that ultimately lead to psychological flexibility. These processes include acceptance, cognitive discontinuity, self as the background, relationship with the present time, values, and committed action . In this research, therapy based on acceptance and commitment will be implemented in 10 sessions (90 minutes each) using a treatment package (Haze, 2016).</i_keyword>
      <i_keyword>Intervention group: Cognitive-Behavioral Therapy: A kind of psychotherapy that helps patients to reach thoughts and feelings that affect their behavior. The cognitive-behavioral training and therapeutic sessions refer to sessions that will be conducted for at least 10 sessions (90 minutes each), during which cognitive-behavioral techniques will be taught using cognitive-behavioral therapy for anxiety and dental phobias package(Ost, Öst, &amp; Skaret, 2013).</i_keyword>
      <i_keyword>Control group: Control group will not receive any treatment during the study period , However, after the end of the research, the intervention will be done for them, free of charge.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dental anxiety score in Stouthard dental anxiety Inventory. Timepoint: Before intervention, after intervention, after 3 months. Method of measurement: Stouthard dental anxiety Inventory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Cognitive emotion regulation. Timepoint: Before intervention, after intervention, after 3 months. Method of measurement: Cognitive Emotion Regulation Questionnaire by  Spinhoven with 36 questions.</sec_outcome>
      <sec_outcome>Oral Health-related Quality of Life. Timepoint: Before intervention, after intervention, after 3 months. Method of measurement: Oral Health-related Quality of Life (OHIP-14).</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Esfahan University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Islamic Azad University</source_name>
      <source_name>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-04-30</approval_date>
        <contact_name>Ethics committee of Islamic Azad University - Ahvaz Branch</contact_name>
        <contact_address>Islamic Azad University - Ahvaz Branch, Farhangshahr, Golestan Blvd Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
