<?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>IRCT20171228038109N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-10</date_registration>
      <primary_sponsor>Khorasan Razavi Health Center</primary_sponsor>
      <public_title>The effect of self-control training and communication skills in nerve neuropathy of diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of self-control training and communication skills on emotional regulation, perceived pain severity and self-care behaviors caused by nerve neuropathy in diabetic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30908</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>Diabetic nerve neuropathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  included 15 diabetic nerve neuropathy  patients in Shahid Ghodsi Health Center in city of Mashhad. For 10 sessions of 90 minutes and for 1 month, self-control training and communication skills were performed on them. Intervention 2: Control group: The study included 15 diabetic neuropathic patients in Shahid Ghodsi Health Center in city of Mashhad. The effectiveness of self-control training and communication skills on these patients was not completed and only filled the questionnaires(Pre-test and post-test) at the same time as the intervention group, and there was an explanation for routine daily care in these patients.</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:
Only part of the data, such as Information on the main outcome, or the like, can be shared

When:
Start the access period from 1398

To whom:
Data is available for Researchers working in Academia and Academia

Conditions:
In Patients who develop diabetic neuropathy and type 2 diabetes, they are affected by conditions and symptoms that damage their nerve and the  involvement of a nerve in a region. data Analysis was analyzed using   descriptive statistics (mean and standard deviation) and inferential statistics (multivariate covariance test).

Where to obtain:
Mashhad Health Center No. 3, to the website: http://behdasht3.mums.ac.ir, tel: 051337634007 Address: Boulevard Khayyam, Boulevard Ershad 8, St.Petersburg, on message 6, and
  Shaheed Ghodsi Health Center, at the end of Sanabad Street, along with  the blood transfusion organization, the diabetes education unit, Mrs. Saydeh Mehri Alishi and Ms. Maryam Keivan Jafari. Address: End of Sanabad Street, next to the blood transfusion organization

How to obtain:
The Research and research done according to the Intervention method and test hypotheses that were performed during the specified period are  made.from defense date to 31/4/1396

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyyedeh Mehri Boland Ashtian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Next to the Blood Transfusion Organization, at the end of Sanabad, Mashhad</address>
        <city>Mashhdd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9185837715</zip>
        <telephone>+98 513844007</telephone>
        <email>behdasht3@mums.ac.ir</email>
        <affiliation>Health center number 3 of Mashhad city, Shahid Ghodsi Health Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Keivan Jafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Next to the Blood Transfusion Organization, at the end of Sanabad, Mashhad</address>
        <city>Mashhsd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9185837715</zip>
        <telephone>+98 513844007</telephone>
        <email>behdasht3@mums.ac.ir</email>
        <affiliation>Mashhad Health Center No. 3, Shahid Ghodsi Health Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who have been diagnosed with Neuropathy symptoms in the case
Patients with type 2  diabetes most of the symptoms, such as nausea, paresthesia and pain in the limbs and needle fixation at night
Patients of both sexes have a duration of more than five years
Patients who are based on the age range specified by the subject
Patients age 47 or older are allowed to enter the study because of diabetic neuropathy that occurs at an advanced age</inclusion_criteria>
      <agemin>47 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with type 1 diabetes
Patients who do not have a ّfile at the Health center
Patients whose symptoms of neuropathy have not been confirmed in the case
Patients who are about 47 years of age or older are not allowed to enter the study because diabetic neuropathy does not occur at an early age</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08.43</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition with diabetic autonomic (poly)neuropathy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  included 15 diabetic nerve neuropathy  patients in Shahid Ghodsi Health Center in city of Mashhad. For 10 sessions of 90 minutes and for 1 month, self-control training and communication skills were performed on them</i_keyword>
      <i_keyword>Control group: The study included 15 diabetic neuropathic patients in Shahid Ghodsi Health Center in city of Mashhad. The effectiveness of self-control training and communication skills on these patients was not completed and only filled the questionnaires(Pre-test and post-test) at the same time as the intervention group, and there was an explanation for routine daily care in these patients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Emotion regulation, perceived pain intensity, self-care behaviors. Timepoint: The time interval at the beginning of the study on patients, pre-test (before intervention), 10 sessions 90 minutes and 30 days to post-test (after  intervention). Method of measurement: Emotion scoring score in the Graz Thrice disorders questionnaire, perceived pain intensity score in the McGill pain questionnaire, self-care  behavior score questionnaire, self-care behavior questionnaire of Tubert and Glasgow  diabetic patients.</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>Khorasan Razavi Health Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-02-07</approval_date>
        <contact_name>Ethics committee of Islamic Azad University, Science and Research Branch of Neyshabour</contact_name>
        <contact_address>Research Area, Neyshabur, Razavi Khorasan Province Neyshabur Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
