<?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>IRCT20200604047657N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-22</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effectiveness of psychological treatments and exercises on life efficacy and treatment of hemodialysis patients</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of acceptance and commitment therapy (ACT) before dialysis, and exercises with  mindfulness in dialysis time on hemodialysis patients in terms of dialysis adequacy, biological and psychological indicators.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48747</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The simple randomization method will be done , using the random numbers table and assigning each number to a patient.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Renal Failure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: Effectiveness of ACT before dialysis: Training the ACTto dialysis patients and study the effect of this treatment model on mental health and dialysis efficacy in this patients. Intervention 2: Intervention group2 : Training exercises with mindfullness in dialysis period and study its effect on mental health and dialysis efficacy. Intervention 3: Control group: There is no intervention in the group.</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 of the statistical data of patients

When:
six months after publishing the evidences

To whom:
Professors, patients, treatmenr personals

Conditions:
For increase the treatment efficacy

Where to obtain:
www.aubir.ac.ir

How to obtain:
Asking from the azad university of birjand or visit the website of university

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali kazemi daluee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No0 327, jahanara7Ave</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9175756422</zip>
        <telephone>0098 51 8479808</telephone>
        <email>alikazemidaluee1350@gmail.com</email>
        <affiliation>Emam reza university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali kazemi daluee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No327, jahanara7Ave</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9175756422</zip>
        <telephone>0098 51 8479808</telephone>
        <email>alikazemidaluee1350@gmail.com</email>
        <affiliation>Emam reza university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>having an effective arterial and venous fistula, completing the testimonial form, having a minimum diploma, minimum age of 60, doing hemodialysis for 6 months, having a desire to participate in research, lack of participation in other psychological periods.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The experience of kidney transplantation, chemotherapy or radiotherapy, no hospitalizing in interaction period, lung disease need to oxigen therapy,  diabetes and blood pressure, lack of consciousness in place and time, mental and physical disability, infection, and leg wounds, are excluded from the group in the event of an illness in the exercise time.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I13.11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hypertensive heart and chronic kidney disease without heart failure, with stage 5 chronic kidney disease, or end stage renal disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: Effectiveness of ACT before dialysis: Training the ACTto dialysis patients and study the effect of this treatment model on mental health and dialysis efficacy in this patients.</i_keyword>
      <i_keyword>Intervention group2 : Training exercises with mindfullness in dialysis period and study its effect on mental health and dialysis efficacy</i_keyword>
      <i_keyword>Control group: There is no intervention in the group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dialysis efficacy. Timepoint: Once a month from 15 August( since get the patient). Method of measurement: Daugirdas index to assess the quality of dialysis.</prim_outcome>
      <prim_outcome>Depression. Timepoint: Once a month from 15 August( since get the patient). Method of measurement: Doss scale of depression.</prim_outcome>
      <prim_outcome>Avoidance. Timepoint: Once a month from 15 August( since get the patient). Method of measurement: Avoidance questionnaire.</prim_outcome>
      <prim_outcome>Disease Rumination. Timepoint: Once a month from 15 August( since get the patient). Method of measurement: Multidimensional Rumination scale.</prim_outcome>
      <prim_outcome>Disease Perception. Timepoint: Once a month from 15 August( since get the patient). Method of measurement: Illness Perception Questionnaire.</prim_outcome>
      <prim_outcome>Hope. Timepoint: Once a month from 15 August( since get the patient). Method of measurement: Snyder Hope Scale.</prim_outcome>
      <prim_outcome>Emotional efficacy. Timepoint: Once a month from 15 August( since get the patient). Method of measurement: Emotion efficacy scale.</prim_outcome>
      <prim_outcome>Global health. Timepoint: Once a month from 15 August( since get the patient). Method of measurement: Health questionnaire.</prim_outcome>
      <prim_outcome>Spiritual health. Timepoint: Once a month from 15 August( since get the patient). Method of measurement: Spiritual well-being questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Biological index. Timepoint: Once a month from 15 August( get the patient). Method of measurement: Monthly Routine Tests.</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>2020-06-23</approval_date>
        <contact_name>Ethics committee of birjand university of medical sciences</contact_name>
        <contact_address>Emam zaman hospital, sarakhs Ave, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
