<?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>IRCT2016030826961N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-05-22</date_registration>
      <primary_sponsor>Vice chancellor for research of  Hamadan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Spiritual Care on Life Expectancy and Death Anxiety in Hemodialysis patients.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of the spiritual care on life expectancy and death anxiety in patients with end-stage chronic kidney disease under hemodialysis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-07-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size></target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22220</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Randomized: permutation block.</study_design>
      <phase>2-3</phase>
      <hc_freetext>End stage kidney disease.</hc_freetext>
      <i_freetext>Intervention 1: The case group: (1): The case group will receive spiritual care besides the routine treatments. &#13;
The patients in the case and control group will complete a demographic information questionnaire before the intervention. The patients in the case and control group will also complete the Templer’sdeath anxiety scale and Schneider’s life expectancy scale before and after the intervention. Mean score of death anxiety and life expectancy of the two groups before and after the intervention will be eventually presented and compared. Prior to implementation of the spiritual care program, library resources and articles will be reviewed to prepare a care training package (booklets and CDs) for hemodialysis patients in the case group. The spiritual care program in this study will be held in four one-hour sessions individually twice a week in the morning or evening shift at bedside in the hemodialysis ward. The spiritual care model in the case group will include the following items: A- supportive presence involving the following items: 1. developing trust, empathy, and honesty between nurses and patients to establish a good relationship during sessions, 2. carefully listening to the patients’words, concerns, and fears, 3. supporting the patients spiritually and mentally, 4. enhancing patients’ hope and inner forces, 5. uttering positive sentences and reinforcing sound constructive thoughts, 6. communicating with patients verbally and non-verbally, 7. answering patients’ questions, explaining the course of treatment to the patients, and providing them with information on their disease in order to diminish their physical and mental stresses, and 8. encouraging the patients to use recreational places, B- support patients’ rituals: 1. helping the patients to find meaning of their life and the fact that no event is out of the divine providence, 2. providing necessary facilities for doing religious practices (including a turbah and a prayer rug and recommending patients’ family to help the patients in saying prayers), 3. encouraging the patients to say prayers and read Quran, 4. encouraging the patients to express their religious beliefs, and 5. encouraging the patients to talk with clergymen, and C- use of supportive systems: 1. encouraging the patients to communicate with people with whom they feel comfortable, 2. supporting the patients emotionally on the part of patients’ family and medical team such that the patients feel valued, including loving, accepting, and respecting them, 3. recommending patients’ family to help the patients do their daily activities, such as household chores, and 4. encouraging the patients to go to work. It should be noted that the first session involve principles on the supportive presence. The support for patients’ rituals will be emphasized in the second session. The third session will be dedicated to patients’ use of specific supportive systems. The materials taught in the first three sessions will be concluded in the fourth session, and the patients will be requested to express their views and questions about the spiritual care provided for them. It will be tried to obviate any ambiguity that may arise about the training materials. Intervention 2: The control group (Group 2): This group will receive the routine medical and nursing care. Contains Hemodynamic monitoring  During Hemodialysis، Correct hemodialysis and Control complications of hemodialysis.</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></firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address></address>
        <city></city>
        <country1></country1>
        <zip></zip>
        <telephone></telephone>
        <email></email>
        <affiliation></affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Khodayar Oshvandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>College of nursing-Opposite the People's Park</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>38698-65178</zip>
        <telephone>+98 81 3838 0320</telephone>
        <email>oshvandi@umsha.ac.ir</email>
        <affiliation>Hamadan University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria of the study: 1. end-stage chronic renal failure confirmed by the physician, 2. knowing the diagnosis and prognosis of their disease, 3. hemodialysis at least for 6 months, 4. having physical and mental capability of answering the questions, 5. not knowing the mental disorders diagnosed by the physician, and 6. having minimum ability of reading and writing.&#13;
 Exclusion criteria of the study: 1. incidence of any stressful event for patients once the study has begun, 2. unwillingness to continue the study for any reason, and 3. hospitalization because of the disease relapse.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease, stage 5</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The case group: (1): The case group will receive spiritual care besides the routine treatments. &#13;
The patients in the case and control group will complete a demographic information questionnaire before the intervention. The patients in the case and control group will also complete the Templer’sdeath anxiety scale and Schneider’s life expectancy scale before and after the intervention. Mean score of death anxiety and life expectancy of the two groups before and after the intervention will be eventually presented and compared. Prior to implementation of the spiritual care program, library resources and articles will be reviewed to prepare a care training package (booklets and CDs) for hemodialysis patients in the case group. The spiritual care program in this study will be held in four one-hour sessions individually twice a week in the morning or evening shift at bedside in the hemodialysis ward. The spiritual care model in the case group will include the following items: A- supportive presence involving the following items: 1. developing trust, empathy, and honesty between nurses and patients to establish a good relationship during sessions, 2. carefully listening to the patients’words, concerns, and fears, 3. supporting the patients spiritually and mentally, 4. enhancing patients’ hope and inner forces, 5. uttering positive sentences and reinforcing sound constructive thoughts, 6. communicating with patients verbally and non-verbally, 7. answering patients’ questions, explaining the course of treatment to the patients, and providing them with information on their disease in order to diminish their physical and mental stresses, and 8. encouraging the patients to use recreational places, B- support patients’ rituals: 1. helping the patients to find meaning of their life and the fact that no event is out of the divine providence, 2. providing necessary facilities for doing religious practices (including a turbah and a prayer rug and recommending patients’ family to help the patients in saying prayers), 3. encouraging the patients to say prayers and read Quran, 4. encouraging the patients to express their religious beliefs, and 5. encouraging the patients to talk with clergymen, and C- use of supportive systems: 1. encouraging the patients to communicate with people with whom they feel comfortable, 2. supporting the patients emotionally on the part of patients’ family and medical team such that the patients feel valued, including loving, accepting, and respecting them, 3. recommending patients’ family to help the patients do their daily activities, such as household chores, and 4. encouraging the patients to go to work. It should be noted that the first session involve principles on the supportive presence. The support for patients’ rituals will be emphasized in the second session. The third session will be dedicated to patients’ use of specific supportive systems. The materials taught in the first three sessions will be concluded in the fourth session, and the patients will be requested to express their views and questions about the spiritual care provided for them. It will be tried to obviate any ambiguity that may arise about the training materials.</i_keyword>
      <i_keyword>The control group (Group 2): This group will receive the routine medical and nursing care. Contains Hemodynamic monitoring  During Hemodialysis، Correct hemodialysis and Control complications of hemodialysis.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Death Anxiety. Timepoint: Before and one month after the start of the study. Method of measurement: Templer Death Anxiety Questionnaire.</prim_outcome>
      <prim_outcome>Life Expectancy. Timepoint: Before and one month after the start of the study. Method of measurement: Life Expectancy Schneider 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>Vice chancellor for research of  Hamadan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-03-03</approval_date>
        <contact_name>Ethics committee of Hamadan University of Medical Sciences</contact_name>
        <contact_address>Beginning of Ayatollah Kashani Blvd,Khajeh Rashid Crossroads. Hamadan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
