<?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>IRCT2017022322466N13</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-05-22</date_registration>
      <primary_sponsor>Vice chancellor for research, Bushehr University of medical sciences</primary_sponsor>
      <public_title>The effect of spiritual religious psychotherapy on the self-concept and the sense of coherence in cancer</public_title>
      <acronym></acronym>
      <scientific_title>The effect of spiritual religious psychotherapy on the self-concept and the sense of coherence in cancer Patients: Clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-04-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size></target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19366</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Permuted block randomization, using blocks of four, will be used.</study_design>
      <phase>2</phase>
      <hc_freetext>Cancer.</hc_freetext>
      <i_freetext>Intervention 1: In the case group, the intervention and educational package is based on Richards and Bergin's spiritual religious psychotherapy model, on the basis of Islam. This model consists of six steps, which are: First step (Multicultural spiritual sensitivity); second step (establish a spiritually open and safe relationship); third step (attend to potential ethical concerns); fourth step (conducting a religious and spiritual assessment); fifth step (set appropriate spiritual therapy goals); and the sixth step (appropriately implement spiritual interventions). Interventions which will be used are: Prayer and benediction; recitation; the rites and rituals; forgiveness; repentance; faith and trust in God; patience; and using the participants' religious supporting system. In writing the educational package some parts of Leila Hosseini's method in an article titled "The effectiveness of spiritual intervention on dopamine and serotonin receptors gene expression in women with breast cancer" done at 2015-2016 has been used. The intervention will be done in eight sessions of one hour and half; and twice a weak (because if prolonged there is likelihood of sample loss); by a seminary expert and in the form of groups of 10. In order to approve and present the subjects an expert in psychology and a seminary expert, will be invited. Activities of each session are: 1- Checking the exercises of the previous session; 2- Giving feedback to the participants; 3- Giving a summary of the previous session, in order to make continuity between the subjects discussed and to mentally prepare the participants for a new subject; 4- Presenting each sessions' subject and exercises; 5- Giving home works for the next session; and 6-Summing up the session topic. During the intervention, the case group will not be prohibited from their medical interventions. Intervention 2: In the control group only the oncologist's recommendations will run as routine and at the end of sampling; in order to comply with ethical principles, a pamphlet about spirituality and its concepts will be given to them.</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>Doctor Shahnaz Pooladi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of nursing and midwifery, Bushehr University of medical sciences, Rishehr avenue, Sabzabad avenue, Bushehr</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7518759577</zip>
        <telephone>+98 77 3345 0187</telephone>
        <email>pouladi2008@yahoo.com; sh.pooladi@bpums.ac.ir</email>
        <affiliation>Bushehr University of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Doctor Shahnaz Pooladi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of nursing and midwifery, Bushehr University of medical sciences, Rishehr avenue, Sabzabad avenue, Bushehr</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7518759577</zip>
        <telephone>+98 77 3345 0187</telephone>
        <email>Pouladi2008@yahoo.com; sh.pooladi@bpums.ac.ir</email>
        <affiliation>Bushehr University of medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Cancer diagnosed by oncology doctor; suffering from the disease for more than three months; capable of taking part in classes; believe in Islam; being aware of the disease; done a course of chemotherapy; having the least ability to read and write; and ages 18 to 60 years.&#13;
Exclusion criteria: Death while running the study; psychological diseases (for example: Schizophrenia, Bipolar disorder and other); lack of voluntary consent to participate in research or withdrawal from continued participation; and irregular participation in classes.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C80.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the case group, the intervention and educational package is based on Richards and Bergin's spiritual religious psychotherapy model, on the basis of Islam. This model consists of six steps, which are: First step (Multicultural spiritual sensitivity); second step (establish a spiritually open and safe relationship); third step (attend to potential ethical concerns); fourth step (conducting a religious and spiritual assessment); fifth step (set appropriate spiritual therapy goals); and the sixth step (appropriately implement spiritual interventions). Interventions which will be used are: Prayer and benediction; recitation; the rites and rituals; forgiveness; repentance; faith and trust in God; patience; and using the participants' religious supporting system. In writing the educational package some parts of Leila Hosseini's method in an article titled "The effectiveness of spiritual intervention on dopamine and serotonin receptors gene expression in women with breast cancer" done at 2015-2016 has been used. The intervention will be done in eight sessions of one hour and half; and twice a weak (because if prolonged there is likelihood of sample loss); by a seminary expert and in the form of groups of 10. In order to approve and present the subjects an expert in psychology and a seminary expert, will be invited. Activities of each session are: 1- Checking the exercises of the previous session; 2- Giving feedback to the participants; 3- Giving a summary of the previous session, in order to make continuity between the subjects discussed and to mentally prepare the participants for a new subject; 4- Presenting each sessions' subject and exercises; 5- Giving home works for the next session; and 6-Summing up the session topic. During the intervention, the case group will not be prohibited from their medical interventions.</i_keyword>
      <i_keyword>In the control group only the oncologist's recommendations will run as routine and at the end of sampling; in order to comply with ethical principles, a pamphlet about spirituality and its concepts will be given to them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-concept. Timepoint: Before the intervention and after finishing eight educational sessions for each individual. Method of measurement: Beck's self-concept questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sense of coherence. Timepoint: Before the intervention and after finishing eight educational sessions for each individual. Method of measurement: Antonovsky's sense of coherence 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>Vice chancellor for research, Bushehr University of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-02-20</approval_date>
        <contact_name>Ethics committee of Bushehr University of medical sciences</contact_name>
        <contact_address>School of nursing and midwifery; Bushehr University of medical sciences; Rishehr avenue; Sabzabad avenue; Bushehr Bushehr  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
