<?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>IRCT2013112815577N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-04-06</date_registration>
      <primary_sponsor>.....</primary_sponsor>
      <public_title>The Effectiveness of Acceptance and Commitment Therapy on Chronic Pain of Children</public_title>
      <acronym>CHACT</acronym>
      <scientific_title>The Clinical Trial of Acceptance and Commitment Therapy  (CHACT) on the Psychological  Flexibility in Pain, Function, Quality of life, Internalizing and Externalizing Symptoms of  7 to 12 years - old  Children with Chronic Pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-06-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14804</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic pain.</hc_freetext>
      <i_freetext>Intervention 1: Experimental  group: The designed protocol of CHACT was individually implemented for 8 sessions (each session is about one hour) on them. For protocol design, on one hand, the resources associated with acceptance and commitment therapy and psychological therapy for children, and the other hand,  the initial version of acceptance and commitment therapy on children ( To consult with Association  for  Contextual  Behavioral  Science (ACBS)), were used. The basic components of this protocol include acceptance, cognitive defusion, valuing,  behavioral commitment, etc. The objective of the acceptance is that patients are encouraged to welcome unsolicited thoughts and feelings. Thus, there is a way to change avoiding from painful situations. The goal of cognitive defusion is reduction in the true sense of inner experiences. That, thoughts should be considered only as thought and reduced their impact on behavior. In this treatment, the values are considered as elements of life and they stimulate the patients to engage in some specific activity. The patients learn to determine their value orientations in different aspects ( Eg, family, spirituality ) and act in accordance with them. The behavioral commitments lead to realize the values. they will continue until in person be made the great models of flexible and effective behaviors that are associated with the values. &#13;
It should be noted that at the end of each session, in accordance with the content of the protocol, a 20-minute session is considered for children`s parent. Intervention 2: Control group: They received conventional medical treatment in the hospitals.</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. Mohammad Reza Shairi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahed University, In front of Shrine, Persian Gulf Freeway, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 5121 2470</telephone>
        <email>Shairigm@yahoo.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soheila Ghomian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahed University, In front of Shrine, Persian Gulf Freeway, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 3627 0702</telephone>
        <email>Ghomian_s@yahoo.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Being in the age range of 7 to 12; Engagement with education; Obtain a score of 13 to 29 (moderate disability) in Function Disability Inventory (FDI); A history of developing chronic pain for 6 months or more and at least 3 months of the first medical treatment in relation to chronic pain according to viewpoint of physician; the ability to attend meetings according to confirmation of physician.&#13;
Exclusion criteria: Absence of the above conditions.</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R52.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic intractable pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Experimental  group: The designed protocol of CHACT was individually implemented for 8 sessions (each session is about one hour) on them. For protocol design, on one hand, the resources associated with acceptance and commitment therapy and psychological therapy for children, and the other hand,  the initial version of acceptance and commitment therapy on children ( To consult with Association  for  Contextual  Behavioral  Science (ACBS)), were used. The basic components of this protocol include acceptance, cognitive defusion, valuing,  behavioral commitment, etc. The objective of the acceptance is that patients are encouraged to welcome unsolicited thoughts and feelings. Thus, there is a way to change avoiding from painful situations. The goal of cognitive defusion is reduction in the true sense of inner experiences. That, thoughts should be considered only as thought and reduced their impact on behavior. In this treatment, the values are considered as elements of life and they stimulate the patients to engage in some specific activity. The patients learn to determine their value orientations in different aspects ( Eg, family, spirituality ) and act in accordance with them. The behavioral commitments lead to realize the values. they will continue until in person be made the great models of flexible and effective behaviors that are associated with the values. &#13;
It should be noted that at the end of each session, in accordance with the content of the protocol, a 20-minute session is considered for children`s parent.</i_keyword>
      <i_keyword>Control group: They received conventional medical treatment in the hospitals</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Psychological  flexibility in Pain. Timepoint: Before the treatment, after the treatment,  first follow-up (1.5 month after the treatment) and second follow-up( 5.5 month after the treatment). Method of measurement: Psychological Inflexibility in Pain Scale (PIPS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Function. Timepoint: Before the treatment, after the treatment, first follow-up (1.5 month after the treatment)and second follow-up(5.5 month after the treatment). Method of measurement: Function Disability Inventory (FDI).</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: Before treatment, after treatment, first follow-up (1.5 month after treatment)and second follow-up(5.5 month after treatment. Method of measurement: The Health-Related  Quality of Life KIDSCREEN- 27 Questionnaire.</sec_outcome>
      <sec_outcome>Internalizing and Externalizing Symptoms. Timepoint: Before the treatment, after the treatment, first follow-up (1.5 month after the treatment)and second follow-up(5.5 month after the treatment. Method of measurement: Child Behavior Check List (CBCL).</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>.....</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-10-29</approval_date>
        <contact_name>Department of education and  graduate, Shahed University</contact_name>
        <contact_address>Shahed University, In front of shrine,  Persian Gulf Freeway, Tehran, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
