<?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>IRCT20180607040001N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-21</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of cognitive behavioral group therapy in patients with chronic neuropathic pain</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of group cognitive-behavioral therapy (CBT) on pain coping strategies, perception, intensity and pain self-efficacy in patients with chronic neuropathic pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-01-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33377</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Pain coping strategies were measured by pain coping strategies questionnaire (CSQ) (Rosenstiel and keefe, 1983) , pain perception was measured by pain beliefs and perception inventory (PBPI) (Williams and Thorn, 1989) , pain intensity was measured by west Haven-Yale multidimensional pain inventory (Kerns et all, 1985) and pain self- efficacy was measured by pain self- efficacy questionnaire (Nicholas, 1989), Randomization description: In the first stage, a simple randomization was performed using a random numbers table, and the direction of reading numbers was assigned from right to left in the current study. The randomization unit was individual. In the second stage, the random allocation concealment was done using the sequentially numbered, opaque, sealed envelopes (SNOSE) method. In the third stage, the random allocation process was implemented as well as to avoid the bias, it was necessary to choose a person other than the researchers who were involved in creating a randomized program in order, Blinding description: In the current study, the analyst and participants were not aware of any type of intervention in each group and it was a double-blind study. The participants were blind to their allocation, meaning that they were unaware of being in experimental and control groups until after the completion of the study. In addition, the outcome evaluator did not know the group of each patient or participant.</study_design>
      <phase>N/A</phase>
      <hc_freetext>chronic neuropathic pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group experienced cognitive behavioural group therapy (CBGT) and did pretest, posttest and follow up. Intervention 2: Control group: cortrol group didn't have any therapy except medicine therapy. Control group did pretest, post-test and follow up.</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:
-

When:
-

To whom:
Public

Conditions:
-

Where to obtain:
-

How to obtain:
-

Comments:
-</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoumeh Dehestani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 96 , Edalat 2 alley , Baghban mahale st. , Modaress St. , Babol ,  Mazandaran</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0000000000</zip>
        <telephone>+98 11 3222 9146</telephone>
        <email>ddehestanim@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Bahram Mirzaian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Psychotherapy and consultation center of Bamdad, peyvandi street</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0000000000</zip>
        <telephone>+98 11 3325 9528</telephone>
        <email>bahrammirzaian@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Participants who recognized chronic neuropathic pain by neurologist and don't have significant physical sickness.
Whole participants are female.
Age range of 20 to 60 years old.
Inhabitant of Babol (from Babol).
They haven't mental disorders.
They have conscious satisfaction.
They have education of high School and higher.
They haven't participation in another instructional and therapeutic classes, simultaneously.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The participants who are absent for over two sessions.
The participants who are unwilling to participate in this study.
The participants who suffer from mental disorders.
The participants who are physically illness.</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>Intervention group: Intervention group experienced cognitive behavioural group therapy (CBGT) and did pretest, posttest and follow up.</i_keyword>
      <i_keyword>Control group: cortrol group didn't have any therapy except medicine therapy. Control group did pretest, post-test and follow up.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain coping strategies, pain perception, pain intensity, pain self-efficacy. Timepoint: Two weeks before intervention. Method of measurement: Pain coping strategies were measured by pain coping strategies auestionnaire (CSQ) (Rosenstiel and keefe, 1983) , pain perception was measured by pain beliefs and perception inventory (PBPI) (Williams and Thorn, 1989) , pain intensity was measured by west Haven-Yale multidimensional pain inventory (Kerns et all, 1985) and pain self- efficacy was measured by pain self- efficacy questionnaire (Nicholas, 1989).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain coping strategies, pain perception, pain intensity, pain self-efficacy. Timepoint: Two weeks after intervention. Method of measurement: En Pain coping strategies were measured by pain coping strategies auestionnaire (CSQ) (Rosenstiel and keefe, 1983) , pain perception was measured by pain beliefs and perception inventory (PBPI) (Williams and Thorn, 1989) , pain intensity was measured by west Haven-Yale multidimensional pain inventory (Kerns et all, 1985) and pain self- efficacy was measured by pain self- efficacy questionnaire (Nicholas, 1989).</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-26</approval_date>
        <contact_name>Ethics committee of Islamic Azad University Sari Branch</contact_name>
        <contact_address>Assistance of Medical, Islamic Azad University Sari Branch Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
