<?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>IRCT20201231049896N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-23</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Effect of spiritual care on patients with  cancer</public_title>
      <acronym></acronym>
      <scientific_title>Effect of spiritual care based on Sound Heart Model on spirtual needs and spiritual Dryness of patients with  cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>104</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53444</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Randomization description: Sampling is done when patients go to the hospital for chemotherapy. The samples will then be randomly divided into two groups of 52 with random allocation in block in intervention (A) and control (B) groups. First, the four blocks are defined as follows: ABAB, BBAA, BABA, BAAB, AABB, ABBA, etc., and individuals according to A and B will be divided into two groups of intervention and control. Patient A was in the supportive educational intervention group through Soroush virtual social network and patient B was in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>بیماران مبتلا به سرطان.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Spiritual care intervention based on the model of sound heart, model of sound heart based on Islamic teachings is the paradigm of the Abrahamic religions that has been registered worldwide. The intervention is 8 virtual sessions over 2 months. Sequence of sessions including: 1. Familiarity and examination of the patient's feelings and attitude to the disease 2. Attention to the positive aspects of the disease on the axis of dualism, expressing the concept of divine testing 3. The effect of different dimensions of health on each other and spiritual self-awareness 4. Development of social relations 5 Exploitation of creation 6. Motivation and values ​​7. Development of relationship with God as a factor of creating hope, courage, optimism, endurance 8. Coping and adaptation. In addition to the above sessions, individuals receive a daily message and must send the word {read در to the researcher in a virtual application. Intervention 2: Control group: They receive only routine hospital care (including training provided by physicians and nurses and hospital training pamphlets). Immediately after the intervention, participants in both groups complete three questionnaires again and are compared to evaluate the effectiveness of the educational and supportive intervention. One month after the end of the intervention, the questionnaires are completed again in order to follow up the intervention.</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 data is potentially shareable after unidentified individuals.

When:
Access period starts 6 months after the results are published

To whom:
Researchers working in academic and scientific institutions will be available

Conditions:
The use of data is allowed by mentioning the source.

Where to obtain:
Nazi Nejat
Arak - Sardasht - Arak University of Medical Sciences
3319693345
nazinejat@gmail.com

sobhan ebrahimpour
No. 23, Kowsar One St., 12 meters from Motahhari., Kohanz., Shahriar., Tehran
3351856639
sobhan.ebrahimpoor.110@gmail.com

How to obtain:
The applicant must first register his / her request through the mentioned communication channels, and after reviewing the request for information, the information will be provided on condition of confidentiality and without identity information. This process will take a minimum of one month and a maximum of 2 months.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sobhan Ebrahimpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 23, Kowsar One St., 12 meters from Motahhari., Kohanz., Shahriar., Tehran</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3351856639</zip>
        <telephone>+98 21 6522 8400</telephone>
        <email>sobhan.ebrahimpoor.110@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nazi Nejat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Third floor., School of Nursing Arak University of Medical Sciences., Sardasht,. Arak</address>
        <city>arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3319693345</zip>
        <telephone>+98 86 3313 6055</telephone>
        <email>nazinejat@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients are diagnosed with a definitive diagnosis of cancer
Patient access and the ability to use social network
The patient 's willingness to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Mental illness
Inability to read and write (illiterate)
Lack of smart phone
Age over 70 years</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D49</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Neoplasms of unspecified behavior</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Spiritual care intervention based on the model of sound heart, model of sound heart based on Islamic teachings is the paradigm of the Abrahamic religions that has been registered worldwide. The intervention is 8 virtual sessions over 2 months. Sequence of sessions including: 1. Familiarity and examination of the patient's feelings and attitude to the disease 2. Attention to the positive aspects of the disease on the axis of dualism, expressing the concept of divine testing 3. The effect of different dimensions of health on each other and spiritual self-awareness 4. Development of social relations 5 Exploitation of creation 6. Motivation and values ​​7. Development of relationship with God as a factor of creating hope, courage, optimism, endurance 8. Coping and adaptation. In addition to the above sessions, individuals receive a daily message and must send the word {read در to the researcher in a virtual application.</i_keyword>
      <i_keyword>Control group: They receive only routine hospital care (including training provided by physicians and nurses and hospital training pamphlets). Immediately after the intervention, participants in both groups complete three questionnaires again and are compared to evaluate the effectiveness of the educational and supportive intervention. One month after the end of the intervention, the questionnaires are completed again in order to follow up the intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Spiritual needs score in the Spiritual Needs Questionnaire (SpNQ). Timepoint: Before the intervention, immediately after the intervention, one month after the end of the intervention. Method of measurement: Spiritual Needs Questionnaire (SpNQ).</prim_outcome>
      <prim_outcome>Spiritual  Dryness score in the spiritual  Dryness  Scale (SDS). Timepoint: Before the intervention, immediately after the intervention, one month after the end of the intervention. Method of measurement: Spiritual Dryness Scale (SDS).</prim_outcome>
      <prim_outcome>Spiritual health score in the spiritual health questionnaire. Timepoint: Before the intervention, immediately after the intervention, one month after the end of the intervention. Method of measurement: spiritual health of Palutzin and Ellison Questionnaires.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-28</approval_date>
        <contact_name>Ethics committee of arak University of Medical Sciences</contact_name>
        <contact_address>No. 23, Kowsar One St., 12 meters from Motahhari., Kohanz., Shahriar., Tehran tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
