<?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>IRCT20201014049021N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-01</date_registration>
      <primary_sponsor>Rajaei Heart Center</primary_sponsor>
      <public_title>The effect of spiritual care program on quality of life and resilience of patients with heart failure</public_title>
      <acronym></acronym>
      <scientific_title>The effect of spiritual care program on quality of life and resilience of patients with heart failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51616</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: EVA therapy and space construction, Randomization description: Block size 6.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Quality of Life. Condition 2: Resilience.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group Will receive Spiritual care program (educational booklet and two CDs) , which includes two one-and-a-half hour sessions by group discussion and lecture in groups of 5 at the CCUG training site of  Shahid Rajaei Heart Hospital will be implemented. The cause of corona  disease will be virtual. The content of the educational booklet is based on the four main axes of spiritual care. These four main  include: the importance of communicating with God, the importance communicating of with oneself, the importance of communicating with others, and the importance of communicating with nature because most mental health problems are caused by having unhealthy relationships and will be followed for a month to intervene. The content of the two CDs is the sound of nature and the music of Mozart, which the patient will listen to for a month. The intervention group will complete a questionnaire of quality of life, resilience and spirituality before the intervention and after completing a one-month follow-up. Intervention 2: Control group:  will receive only routine nursing care.  and will complete a questionnaire of quality of life, resilience and spirituality before the intervention and after completing a one-month follow-up.</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:
The results of the data and the method of work are published in the article

When:
Three months after the results are published

To whom:
All applicants

Conditions:
Use in scientific research is allowed

Where to obtain:
Frideh.movahedimoghadam@gmail.com

How to obtain:
by Email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fidan shabani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rajai Heart Center , next to Mellat Park,  Vali Asr St.,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1995614331</zip>
        <telephone>+98 21 2392 3312</telephone>
        <email>fidannahal@yahoo.com</email>
        <affiliation>Rajaei Heart Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fidan shabani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rajaei Heart Center, Vali Asr Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1995614331</zip>
        <telephone>0212392312</telephone>
        <email>fidannahal@yahoo.com</email>
        <affiliation>Rajaei Heart Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Heart failure based on clinical signs and echocardiography showing a jump fraction of less than 40%, based on a patient's file approved by a cardiologist.
Age group 18 to 65 years
Being a Muslim
Awareness of time and place
Ability to communicate verbally
No hearing, vision or cognitive impairment
The patient is satisfied to participate in the study
Have complete satisfaction with the referral and follow-up by telephone by the researcher
Adequate literacy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>- At each stage of the study, the patient did not want to continue participating in the study.
Absence from attending spiritual care program training sessions
Critical and emergency situations such as the need for hospitalization, surgery, death of the patient or the occurrence of any other accident
Lack of access by telephone (several times a week) with the patient during the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group Will receive Spiritual care program (educational booklet and two CDs) , which includes two one-and-a-half hour sessions by group discussion and lecture in groups of 5 at the CCUG training site of  Shahid Rajaei Heart Hospital will be implemented. The cause of corona  disease will be virtual. The content of the educational booklet is based on the four main axes of spiritual care. These four main  include: the importance of communicating with God, the importance communicating of with oneself, the importance of communicating with others, and the importance of communicating with nature because most mental health problems are caused by having unhealthy relationships and will be followed for a month to intervene. The content of the two CDs is the sound of nature and the music of Mozart, which the patient will listen to for a month. The intervention group will complete a questionnaire of quality of life, resilience and spirituality before the intervention and after completing a one-month follow-up.</i_keyword>
      <i_keyword>Control group:  will receive only routine nursing care.  and will complete a questionnaire of quality of life, resilience and spirituality before the intervention and after completing a one-month follow-up.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: Before intervention and after one month follow-up. Method of measurement: Iranian Ring Quality Questionnaire designed by Dr. Naderi Heart Failure Fellowship.</prim_outcome>
      <prim_outcome>Resilience. Timepoint: Before intervention and after one month follow-up. Method of measurement: Connor Davidson 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>Personal by the person herself</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-11</approval_date>
        <contact_name>Ethics Committee of Rajaei Heart Center</contact_name>
        <contact_address>Rajaei  Heart Center, Next to Mallet Park, Valiasr Street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
