<?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>IRCT2015120925442N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-01-16</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciense</primary_sponsor>
      <public_title>The effect of narrative writing In hemodialysis treatment</public_title>
      <acronym></acronym>
      <scientific_title>The  effectiveness of narrative writing on depression, Anxiety, stress, life expectancy and quality of life for hemodialysis patients compared with control group</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21279</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Kidney Chronic Disease. Condition 2: Kidney Chronic Disease.</hc_freetext>
      <i_freetext>Intervention 1: Type of intervention: narrative writing intervention program for 2 months, in eight weeks, each one meeting(The intervention group will be asked to write their feelings and experiences during dialysis treatment as the worst and most difficult experience based on Gibbs model (What happened? What were your feelings and thoughts? What was good and bad experience? What lessons have from this situation ? What else did you do? If you could, what will happen again?) in a notebook Narrative writing.). Intervention 2: The control groupe don't get any treatment.</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>Ahmadzadeh, Akram</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kermanshah, Shiroodi Boulevard -  University Street - School of Medicine</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 83 1427 4618</telephone>
        <email>ahmadzadeh.a68@gmail.com</email>
        <affiliation>Kermanshah University of Medical Sciense</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sadeghi, Kheyrollah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kermanshah, Shiroodi Boulevard -  University Street - Medicine of  School</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 83 1427 4618</telephone>
        <email>Kh.sadeghi@yahoo.com</email>
        <affiliation>Kermanshah  University Of  Medicine Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:Earn equivalent score Low to moderate stress in questionnaire of depression and anxiety and stress(DASS-42);Having hemodialysis Disease for at least 6 months;Having The age range of 20 to 55 years;Having at least a high school Education guide;Full satisfaction to participate in the research and signing Informed consent form and written&#13;
Exclusion criteria:Acquisition weak stress or severe scores in the questionnaire of depression and anxiety and stress(DASS-42); Having physical problems that interfere in psychotherapy;Get psychiatric treatment or other psychotherapy at the same time;Having Signs of drug dependency in the past or present;Having Suicidal thoughts.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N25</hc_code>
      <hc_code>N26</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorders resulting from impaired renal tubular function</hc_keyword>
      <hc_keyword>Unspecified contracted kidney</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Type of intervention: narrative writing intervention program for 2 months, in eight weeks, each one meeting(The intervention group will be asked to write their feelings and experiences during dialysis treatment as the worst and most difficult experience based on Gibbs model (What happened? What were your feelings and thoughts? What was good and bad experience? What lessons have from this situation ? What else did you do? If you could, what will happen again?) in a notebook Narrative writing.)</i_keyword>
      <i_keyword>The control groupe don't get any treatment</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Narrative writing. Timepoint: : Before the intervention, the last meeting of the intervention and one month after the end of intervention. Method of measurement: Narrative writing training.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: : Before the intervention, the last meeting of the intervention and one month after the end of intervention. Method of measurement: DASS-42  Questionnaire.</prim_outcome>
      <prim_outcome>Stress. Timepoint: : Before the intervention, the last meeting of the intervention and one month after the end of intervention. Method of measurement: DASS-42  Questionnaire.</prim_outcome>
      <prim_outcome>Depression. Timepoint: : Before the intervention, the last meeting of the intervention and one month after the end of intervention. Method of measurement: DASS-42  Questionnaire.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: : Before the intervention, the last meeting of the intervention and one month after the end of intervention. Method of measurement: Quality of life Questionnaire.</prim_outcome>
      <prim_outcome>Life expectancy. Timepoint: : Before the intervention, the last meeting of the intervention and one month after the end of intervention. Method of measurement: Life expectancy Questionnaire.</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>Kermanshah University of Medical Sciense</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-11-24</approval_date>
        <contact_name>Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Kermanshah. Beheshti Boulevard.Building No. 2 Medical Sciences.Deputy of research and technology.Ethics Committee Kermanshah  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
