<?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>IRCT20181103041532N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-20</date_registration>
      <primary_sponsor>Ghoum University of Medical Sciences</primary_sponsor>
      <public_title>Effect of spiritual counseling on spiritual well-being, depression and anxiety in hemodialysis patients</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Spiritual Counseling based on Sound Heart Model on the Spiritual Well-being, Depression and Anxiety in Dialysis patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>74</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34961</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, Blinding description: Patients are divided into two groups.
A control group that takes only Dialysis treatment.
The other group is Dialysis treatment plus spiritual counseling.
Both groups, the control group and the test group, should remain unaware of the other group, as the information shouldn't exchange between two groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>dialysis.</hc_freetext>
      <i_freetext>Intervention 1: There are two groups. 1. A control group that receives only conventional Dialysis treatments. 2. An intervention group that also undergoes a spiritual intervention in addition to Dialysis treatments. The spiritual intervention in 10 sessions is as the following: First session: Familiarity; second session: People's feelings and attitudes to life stress; Third session: Attention to the positive aspects of the problem and the purpose of life; Fourth session: The concept of health and its dimensions, spiritual well-being and the characteristics of the healthy human being; the Fifth session: The effect of different dimensions of health on each other; the sixth session: Self-awareness of self-care needs; the Seventh session; The development of social communication; the Eighth session; Coping with spiritual care recipes; meeting ninth: Self-control; Teaching the skill of self-assessment daily; Session 10: Completing questionnaires and answering questions and  Final assessing. Intervention 2: Intervention group: Spiritual counseling is based on the ُSALIM heart model on the hemodialysis patient intervention group, while hemodialysis treatment is also performed.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Not defined in the scheme. No need to feel</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>zahra nasrollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>ghadir BLV qom</address>
        <city>qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3713649373</zip>
        <telephone>+98 25 3320 9074</telephone>
        <email>znasrollahi2@gmail.com</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>zahra nasrollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>ghadir BLV Qom</address>
        <city>qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3713649373</zip>
        <telephone>+98 25 3320 9074</telephone>
        <email>znasrollahi2@gmail.com</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adult patients (over 18 years old)
At least the reading and writing skills
Being able to communicate to complete the questionnaire
Not having a history of chronic mental illness in the past and now
Not to use psychosocial drugs, Farsi language, have at least one year of dialysis, dialysis at least twice a week.
Not having a history of attending spiritual meetings or spiritual health training courses simultaneously</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>A severe physical or psychological crisis in addition to kidney failure
Cause of other life-threatening diseases
Unwillingness to continue research on the part of the patient
Transmission for hemodialysis to the other center by the patient
Candidate for renal transplantation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z99.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dependence on renal dialysis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>There are two groups. 1. A control group that receives only conventional Dialysis treatments. 2. An intervention group that also undergoes a spiritual intervention in addition to Dialysis treatments. The spiritual intervention in 10 sessions is as the following: First session: Familiarity; second session: People's feelings and attitudes to life stress; Third session: Attention to the positive aspects of the problem and the purpose of life; Fourth session: The concept of health and its dimensions, spiritual well-being and the characteristics of the healthy human being; the Fifth session: The effect of different dimensions of health on each other; the sixth session: Self-awareness of self-care needs; the Seventh session; The development of social communication; the Eighth session; Coping with spiritual care recipes; meeting ninth: Self-control; Teaching the skill of self-assessment daily; Session 10: Completing questionnaires and answering questions and  Final assessing.</i_keyword>
      <i_keyword>Intervention group: Spiritual counseling is based on the ُSALIM heart model on the hemodialysis patient intervention group, while hemodialysis treatment is also performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Spiritual well-being. Timepoint: After intervention (after 10 consultation sessions). Method of measurement: Questionnaire of Spiritual well-being.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: After intervention (after 10 consultation sessions). Method of measurement: Questionnaire of Anxiety.</prim_outcome>
      <prim_outcome>Stress. Timepoint: After intervention (after 10 consultation sessions). Method of measurement: Questionnaire of Stress.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Stress score. Timepoint: Once upon a spiritual intervention. Method of measurement: Spiritual Health Questionnaire, Stress Questionnaire, Anxiety Inventory.</sec_outcome>
      <sec_outcome>Anxiety Score. Timepoint: After spiritual intervention. Method of measurement: Through the questionnaire.</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>Ghoum University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-11</approval_date>
        <contact_name>Ethics committee of Qom University of Medical Sciences</contact_name>
        <contact_address>Qom University of Medical Sciences opposite of yadegar-e- Imam Ghadir BLV Qom Iran Qom Ghoum Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
