<?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>IRCT20220829055823N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-08-05</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The spiritual education in promoting spiritual well-being, and reducing the consequences of suffering in patients with heart failure.</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the role of spiritual education in promoting spiritual well-being, the characteristic of gratitude and reducing the consequences of suffering in patients with heart failure.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76303</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization was done by simple randomization method.  The unit of randomization is individuals. 30 subjects were divided into intervention and control groups using Microsoft Excel software, part of Rand.  Based on this, a table of random numbers was prepared and the Randbetween function was created, and the subjects were placed in two groups of 15 according to the rows of this table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Spiritual well-being, gratitude, sleep quality, fatigue, self-efficacy, symptoms of anxiety and depression.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group included all patients with heart failure referred to the heart failure department of Shahid Rajaei Hospital in Tehran, who received group intervention based on meaning therapy based on the book Meaning-Centered Therapy Manual in eight 60-minute sessions (one session per week).  Dr. Mary S. and colleagues provide this treatment and it was translated in Iran in the form of a book titled Existential Psychology Guide to Meaning-oriented Therapy by Fatemeh Vaazipour. The content of the sessions related to the intervention group includes:  The content of the first session: getting to know the members of the group and their expectations, determining the policy of the group, establishing a relationship with the members, explaining  Research questionnaires, a brief explanation of the treatment method, and an analysis of meaning therapy and existential analysis were done.  The second session was devoted to investigating and discovering meaning and identity.  The third session was devoted to the ontology of the human body and soul, and the multidimensional aspects of human existence and its unique dimensions.  In the fourth session, the sources of human strength and inner abilities and simple techniques to reduce stress in life were explained. In the fifth session, the existential aspects of a person, the movement from meaninglessness to a meaningful existence, and the expression of the triangle of meaning therapy optimism in the face of adversity were examined.  The sixth session was devoted to the extraction of meaning in suffering and the expression of meaning therapy as a special meaning.  The seventh session was devoted to personal growth and transformation and development of abilities after injury.  Finally, in the eighth session, life in its true meaning and the sources of meaning in life and a life with meaning and purpose were discussed and the sessions were summarized and the intervention post-test was performed. Intervention 2: Control group: The control group included all patients with heart failure who referred to the heart failure department of Shahid Rajaei Hospital in Tehran, and they also received group training based on meaning therapy after the training for the intervention group based on the book Meaning-Centered Therapy Manual in eight sessions of 60 minutes. They received one session per week. This treatment is provided by Dr. Mary S. and colleagues, and it was translated in Iran in the form of a book titled Existential Psychology, a Guide to Meaning-oriented Therapy by Fatemeh Vaazipour. The content of the sessions related to the control group includes: the content of the first session: getting to know the group members and their expectations, determining the group policy, establishing a relationship with the members, explaining the research questionnaires, explaining the essence of the treatment method, and examining the therapeutic meaning and existential analysis. paid. The second session was devoted to the investigation and discovery of meaning and identity. The third session was devoted to the ontology of the human body and soul and the multidimensional aspects of human existence and its unique dimensions. In the fourth session, sources of human strength and inner abilities and simple techniques to reduce stress in life were explained. In the fifth session, the aspects of a person's existence, and the movement from meaninglessness to a meaningful existence, and the expression of the triangle of meaning therapy optimism in the face of adversity were examined. The sixth session was devoted to the extraction of meaning in suffering and the expression of meaning therapy as a special meaning. The seventh session was dedicated to personal growth and development and development of abilities after injury. And finally, in the eighth session, life and its true meaning, the sources of meaning in life, a life with meaning and purpose, and the summary of the sessions were discussed.</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 Not much information available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad-Kazem Atef-Vahid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Hemmat Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 86701</telephone>
        <email>kazemv@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad-Kazem Atef-Vahid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 86701</telephone>
        <email>kazemv@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who have received a definitive diagnosis of heart failure
18 years old and above
having at least a diploma
interested in attending meetings</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Taking psychiatric and psychoactive drugs
Simultaneous participation in other psychological treatments
3 absences in treatment sessions.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F54</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>psychological and behavioral factors associated with disorders or diseases classified elsewhere</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group included all patients with heart failure referred to the heart failure department of Shahid Rajaei Hospital in Tehran, who received group intervention based on meaning therapy based on the book Meaning-Centered Therapy Manual in eight 60-minute sessions (one session per week).  Dr. Mary S. and colleagues provide this treatment and it was translated in Iran in the form of a book titled Existential Psychology Guide to Meaning-oriented Therapy by Fatemeh Vaazipour. The content of the sessions related to the intervention group includes:  The content of the first session: getting to know the members of the group and their expectations, determining the policy of the group, establishing a relationship with the members, explaining  Research questionnaires, a brief explanation of the treatment method, and an analysis of meaning therapy and existential analysis were done.  The second session was devoted to investigating and discovering meaning and identity.  The third session was devoted to the ontology of the human body and soul, and the multidimensional aspects of human existence and its unique dimensions.  In the fourth session, the sources of human strength and inner abilities and simple techniques to reduce stress in life were explained. In the fifth session, the existential aspects of a person, the movement from meaninglessness to a meaningful existence, and the expression of the triangle of meaning therapy optimism in the face of adversity were examined.  The sixth session was devoted to the extraction of meaning in suffering and the expression of meaning therapy as a special meaning.  The seventh session was devoted to personal growth and transformation and development of abilities after injury.  Finally, in the eighth session, life in its true meaning and the sources of meaning in life and a life with meaning and purpose were discussed and the sessions were summarized and the intervention post-test was performed.</i_keyword>
      <i_keyword>Control group: The control group included all patients with heart failure who referred to the heart failure department of Shahid Rajaei Hospital in Tehran, and they also received group training based on meaning therapy after the training for the intervention group based on the book Meaning-Centered Therapy Manual in eight sessions of 60 minutes. They received one session per week. This treatment is provided by Dr. Mary S. and colleagues, and it was translated in Iran in the form of a book titled Existential Psychology, a Guide to Meaning-oriented Therapy by Fatemeh Vaazipour. The content of the sessions related to the control group includes: the content of the first session: getting to know the group members and their expectations, determining the group policy, establishing a relationship with the members, explaining the research questionnaires, explaining the essence of the treatment method, and examining the therapeutic meaning and existential analysis. paid. The second session was devoted to the investigation and discovery of meaning and identity. The third session was devoted to the ontology of the human body and soul and the multidimensional aspects of human existence and its unique dimensions. In the fourth session, sources of human strength and inner abilities and simple techniques to reduce stress in life were explained. In the fifth session, the aspects of a person's existence, and the movement from meaninglessness to a meaningful existence, and the expression of the triangle of meaning therapy optimism in the face of adversity were examined. The sixth session was devoted to the extraction of meaning in suffering and the expression of meaning therapy as a special meaning. The seventh session was dedicated to personal growth and development and development of abilities after injury. And finally, in the eighth session, life and its true meaning, the sources of meaning in life, a life with meaning and purpose, and the summary of the sessions were discussed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Spiritual well-being score in spiritual well-being questionnaire. Timepoint: At the beginning of the study (before the start of the intervention). After the end of the intervention and 6 months after the end of the intervention. Method of measurement: Dashiri spiritual well-being questionnaire.</prim_outcome>
      <prim_outcome>Gratitude score in the gratitude questionnaire. Timepoint: At the beginning of the study (before the start of the intervention). After the end of the intervention and 6 months after the end of the intervention. Method of measurement: Appreciation questionnaire.</prim_outcome>
      <prim_outcome>Anxiety and depression scores in patients' anxiety and depression questionnaire. Timepoint: At the beginning of the study (before the start of the intervention). After the end of the intervention and 6 months after the end of the intervention. Method of measurement: Depression anxiety questionnaire of patients.</prim_outcome>
      <prim_outcome>Score of multidimensional symptoms of fatigue in the list of fatigue symptoms questionnaire. Timepoint: At the beginning of the study (before the start of the intervention). After the end of the intervention and 6 months after the end of the intervention. Method of measurement: Questionnaire of multidimensional symptoms of fatigue.</prim_outcome>
      <prim_outcome>Sleep quality score in sleep quality questionnaire. Timepoint: At the beginning of the study (before the start of the intervention). After the end of the intervention and 6 months after the end of the intervention. Method of measurement: Sleep quality questionnaire.</prim_outcome>
      <prim_outcome>Self-efficacy score in the self-efficacy questionnaire of Sullivan cardiac patients. Timepoint: At the beginning of the study (before the start of the intervention). After the end of the intervention and 6 months after the end of the intervention. Method of measurement: Sullivan Cardiac Self-Efficacy 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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-05</approval_date>
        <contact_name>Iran University Spiritual Health Research Center</contact_name>
        <contact_address>Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
