<?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>IRCT2014052615426N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-06-02</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences, Vice Chancellor for Research Affairs</primary_sponsor>
      <public_title>The Effects of Spiritual and Religious Need-based Interventions on Spiritual Well-being and Anxiety in Elderly People Hospitalized in Cardiac Intensive Care Unit of Imam Reza hospital in Lar City</public_title>
      <acronym></acronym>
      <scientific_title>The Effects of Spiritual and Religious Need-based Interventions on Spiritual Well-being and Anxiety in Elderly People Hospitalized in Cardiac Intensive Care Unit of Imam Reza hospital in Lar City</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-05-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14689</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiey.</hc_freetext>
      <i_freetext>Intervention 1: The participants of the case group undergo spiritual and religious need-based interventions consisted of a 60-90 minute session per day for 3 consecutive days. The interventions include attending to the patient with full consideration for 30 minutes, giving hope to the patient, talking with him/her about spiritual experiences, encouraging the sense of generosity, strengthening the relationships with family and important people in his/her life, providing opportunities for worship and prayer, giving the patient small booklets made by researcher including precious words of religious elders and world’s scientists about hope, generosity and forgiveness, hanging pictures of natural and relaxing landscapes on the walls of the wards, giving the patient Holy Quran and prayer books, providing Walkman for listening to fine music, prayers and Quran verses and facilitating the patient's visits with family members and friends. Intervention 2: Without any intervention on the control group.</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>Elham Hedayati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemeh Collage of Nursing and Midwifery (P.B.U.H)</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 1647 4254</telephone>
        <email>elhamhedayati92@yahoo.com</email>
        <affiliation>Fatemeh Collage of Nursing and Midwifery (P.B.U.H), Shiraz</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Hazrati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemeh Collage of Nursing and Midwifery (P.B.U.H)</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 1647 4254</telephone>
        <email>hazratim@sums.ac.ir</email>
        <affiliation>Fatemeh Collage of Nursing and Midwifery (P.B.U.H), Shiraz</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age over 60 years old; confirmed diagnosis of any type of heart diseases; willingness to participate in the study; lack of cognitive or psychological disorders.&#13;
Exclusion criteria: undergoing other interventions or complementary therapies (such as meditation and yoga) during hospitalization; consuming antidepressants and anti-anxiety medications during the study; deterioration of the patient's condition; repeated myocardial infarction; patients’ severe psychological conflicts due to religious and spiritual interventions and hospital stay of less than three days.</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The participants of the case group undergo spiritual and religious need-based interventions consisted of a 60-90 minute session per day for 3 consecutive days. The interventions include attending to the patient with full consideration for 30 minutes, giving hope to the patient, talking with him/her about spiritual experiences, encouraging the sense of generosity, strengthening the relationships with family and important people in his/her life, providing opportunities for worship and prayer, giving the patient small booklets made by researcher including precious words of religious elders and world’s scientists about hope, generosity and forgiveness, hanging pictures of natural and relaxing landscapes on the walls of the wards, giving the patient Holy Quran and prayer books, providing Walkman for listening to fine music, prayers and Quran verses and facilitating the patient's visits with family members and friends.</i_keyword>
      <i_keyword>Without any intervention on the control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reducing anxiety. Timepoint: At the time of hospitalization (after patient's stabilization) and at the time of discharge. Method of measurement: Spielberger's State-Trait Anxiety Inventory.</prim_outcome>
      <prim_outcome>Increasing spiritual well-being. Timepoint: At the time of hospitalization (after patient's stabilization) and at the time of discharge. Method of measurement: Spiritual Health Inventory (Paloutizan &amp; Ellison).</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>Shiraz University of Medical Sciences, Vice Chancellor for Research Affairs</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-05-25</approval_date>
        <contact_name>Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Zand Blvd, Central building of Shiraz University of Medical Sciences Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
