<?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>IRCT20190819044567N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-30</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect Of Spiritual Counseling On Happiness And Hope Among M.S Patients</public_title>
      <acronym></acronym>
      <scientific_title>The Effect Of Spiritual Counseling On Happiness And Hope Among Patients With Multiple Sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-02-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41672</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Block randomization and do it online by using https://www.sealedenvelope.com website.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple Sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: The content of spiritual counseling sessions is as follows:First Session:• Self-knowledge and understanding of your strengths&amp; weakness, fears, needs and desires• Realistically understand your limitations, shortcomings and disabilities as part of yourself• Accept mistakes and gain experience as a factor in increasing self-esteem and empowerment Second Session:• Acceptance of the God's Divinity and the right of man to determine his own destiny• Consolidation of God's wise will based on the causal system• The wisdom of having human illness Third Session:• Repentance and confession of sins to God and acceptance of your weaknesses• Trying to relax and improve your health and life with hope and positive thoughts• The love of God for His servants and his promise to forgive and ignore human mistakes • The need to reform behaviors and the past to move towards the future Fourth Session:• Emotion control training, emotion regulation techniques, relaxation training, etc.• Understanding your feelings and ways to express your feelings• Expressing repressed and undesirable feelings• having a purpose as a key factor in enjoying life despite illness Fifth Session:• Deep knowledge of the self, in order to realize its enormous and hidden abilities• Recognize your weaknesses and try to fix them• Taking advantage of hope and not succumbing to hopelessness and Avoidance of self-defeat• Avoid comparing yourself with others•  Reliance on yourself and your abilities and avoiding unnecessary dependence on others.Sixth Session:• Thought control due to the extraordinary power of thought creation or destruction• Take advantage of the sad events in life instead of despair and worry, according to a bit of Saadi, “Where one door shuts another opens”.• Modeling successful people Seventh Session:• How to be empowered to solve your own and others problems• Psycho-cognitive empowerment by: Feeling Competent, confident, effective, autonomy and meaningful Eighth Session:• Awareness and belief that the origin of human happiness is his or her own.• Being responsible for life in order to respond appropriately• Control of psychological reactions as an effective factor in physical diseases• Reviewing and summarizing course content. Intervention 2: Control group: No 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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Bagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5 km to Ravandi Arctic Boulevard</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>88715973474</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>bagheri-m@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Afshar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5 km to Ravandi Arctic Boulevard</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715988141</zip>
        <telephone>+98 31 5562 1182</telephone>
        <email>afshar_m_1343@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients with multiple sclerosis who have been diagnosed for three months
Ability to commute and attend sessions
Iranian Citizenship and Residence in Kashan</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Cognitive disorder
Unwillingness to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The content of spiritual counseling sessions is as follows:First Session:• Self-knowledge and understanding of your strengths&amp; weakness, fears, needs and desires• Realistically understand your limitations, shortcomings and disabilities as part of yourself• Accept mistakes and gain experience as a factor in increasing self-esteem and empowerment Second Session:• Acceptance of the God's Divinity and the right of man to determine his own destiny• Consolidation of God's wise will based on the causal system• The wisdom of having human illness Third Session:• Repentance and confession of sins to God and acceptance of your weaknesses• Trying to relax and improve your health and life with hope and positive thoughts• The love of God for His servants and his promise to forgive and ignore human mistakes • The need to reform behaviors and the past to move towards the future Fourth Session:• Emotion control training, emotion regulation techniques, relaxation training, etc.• Understanding your feelings and ways to express your feelings• Expressing repressed and undesirable feelings• having a purpose as a key factor in enjoying life despite illness Fifth Session:• Deep knowledge of the self, in order to realize its enormous and hidden abilities• Recognize your weaknesses and try to fix them• Taking advantage of hope and not succumbing to hopelessness and Avoidance of self-defeat• Avoid comparing yourself with others•  Reliance on yourself and your abilities and avoiding unnecessary dependence on others.Sixth Session:• Thought control due to the extraordinary power of thought creation or destruction• Take advantage of the sad events in life instead of despair and worry, according to a bit of Saadi, “Where one door shuts another opens”.• Modeling successful people Seventh Session:• How to be empowered to solve your own and others problems• Psycho-cognitive empowerment by: Feeling Competent, confident, effective, autonomy and meaningful Eighth Session:• Awareness and belief that the origin of human happiness is his or her own.• Being responsible for life in order to respond appropriately• Control of psychological reactions as an effective factor in physical diseases• Reviewing and summarizing course content</i_keyword>
      <i_keyword>Control group: No intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Happiness Score. Timepoint: Before the intervention and immediately thereafter and one month later. Method of measurement: Oxford Happiness Questionnaire.</prim_outcome>
      <prim_outcome>Hope Score. Timepoint: Before the intervention and immediately thereafter and one month later. Method of measurement: Herth Hope Scale.</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-21</approval_date>
        <contact_name>Ethics committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>5 km to Ravandi Arctic Boulevard Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
