<?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>IRCT20220719055496N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-26</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of adding Transcranial direct current stimulation (TDCS) to acetaminophen codeine in reducing pain in cancer patients</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of adding Transcranial direct current stimulation (TDCS) to acetaminophen codeine in reducing the pain of cancer patients in Isfahan city in 1401</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64919</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After entering, patients will be divided into two groups by random allocation software in individual units by simple randomization method. After that, one of the groups will be randomly assigned to the intervention group and the other group to the control group, Blinding description: The patients included in the study and the health care workers do not know the type of intervention performed (TDCS or not) in the study.</study_design>
      <phase>3</phase>
      <hc_freetext>cancer related pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The pain score of patients in this group is measured at the beginning of the study. Then the patients were treated for pain control with acetaminophen codeine along with Transcranial direct current stimulation (TDCS, with two electrodes that are placed on both sides of the head and then a current of 2 mA passes between them for 20 minutes) for 4 consecutive days in They are placed 4 separate times. After that, in the first week after the intervention, in the second, third and fourth week, the pain score of the patients is again measured by VAS (Visual Analog Scale) ruler. Intervention 2: Control group: The pain score of these patients is measured at the beginning of the study. Then the patients are treated with acetaminophen codeine alone for 4 consecutive days and for 4 separate times. Also, TDCS electrodes are placed on their heads, but no current passes through them. Then the pain of the patients is measured in the first week after the intervention, the second week, the third week and the fourth week by VAS (Visual Analog Scale) ruler.</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:
All data collected from patients can be shared after de-identification

When:
Access starts for one year after the results are published

To whom:
Doctors, researchers

Conditions:
The data will be used to conduct further studies in order to improve the condition of patients

Where to obtain:
Dr. Dorsa Davoodpour

How to obtain:
After sending an email to receive data and verify identity, verify the person's job and the use of the data, the request will be reviewed and if approved, the data will be sent.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dorsa Davoodpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 2, Midas Building, Shahid Alikhani Ave, Shahid Karimian Ave, Baghdaryache St</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8176755967</zip>
        <telephone>+98 31 3786 2350</telephone>
        <email>Dorsa.davoodpour@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dorsa Davoodpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 2, Midas Building, Shahid Alikhani Ave, Shahid Karimian Ave, Baghdaryache St</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8176755967</zip>
        <telephone>+98 31 3786 2350</telephone>
        <email>Dorsa.davoodpour@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Any type of cancer
Suffering from moderate to severe pain caused by cancer based on VAS score (5-10)
Informed consent to participate in the study
Absence of depressive disorders, bipolar disorders, or psychotic disorders based on DSM-V diagnostic criteria during examination by a psychiatrist and a psychiatric assistant
No history of epilepsy and other neurological disorders
Absence of pregnancy
No addiction to drugs and opium
Not having implants in the skull or pacemakers or any other prosthetics
No prior exposure to transcranial stimulation treatments</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The final stage of cancer
Lack of informed consent
Aggravation of cancer symptoms and the need for hospitalization during the study
Intensification of pain in such a way that it is necessary to prescribe strong narcotics (morphine, methadone, oxycodone, pethidine)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G89.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Neoplasm related pain (acute) (chronic)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The pain score of patients in this group is measured at the beginning of the study. Then the patients were treated for pain control with acetaminophen codeine along with Transcranial direct current stimulation (TDCS, with two electrodes that are placed on both sides of the head and then a current of 2 mA passes between them for 20 minutes) for 4 consecutive days in They are placed 4 separate times. After that, in the first week after the intervention, in the second, third and fourth week, the pain score of the patients is again measured by VAS (Visual Analog Scale) ruler</i_keyword>
      <i_keyword>Control group: The pain score of these patients is measured at the beginning of the study. Then the patients are treated with acetaminophen codeine alone for 4 consecutive days and for 4 separate times. Also, TDCS electrodes are placed on their heads, but no current passes through them. Then the pain of the patients is measured in the first week after the intervention, the second week, the third week and the fourth week by VAS (Visual Analog Scale) ruler</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score of cancer patients according to VAS (Visual Analog Scale). Timepoint: before the intervention and one week, two weeks, three weeks and four weeks after the intervention. Method of measurement: The pain score of the patients is measured by the Visual Analog Scale ruler.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-28</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan university of Medical Science, Hezar Jarib St Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
