<?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>IRCT20211026052881N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-13</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>"The effect of spiritual care intervention on anxiety and self-efficacy of family caregivers of patients after coronary artery bypass graft surgery"</public_title>
      <acronym></acronym>
      <scientific_title>"The effect of spiritual care intervention on anxiety and self-efficacy of family caregivers of patients after coronary artery bypass graft surgery"</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59607</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block randomization is performed with equal ratio (1: 1) in the intervention and control groups (A and B) using 4-member block sizes. The sequence within each block will be randomized using Excel software and rand() function.  Eligible candidates will be assigned to one of the intervention or control groups based on a random chain formed after entering the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Prevention, treatment and rehabilitation of cardiovascular diseases.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention includes a spiritual care training program based on the spiritual strategies of Richards and Bergin, which will be theoretically and practically implemented for family caregivers of patients undergoing coronary artery bypass graft surgery. This training program will be done in 6 face-to-face sessions for 60-45 minutes daily. The first session will explain the objectives of the research and the importance of the curriculum and spiritual care. The second session explains the spirituality and mission of the chosen people and its impact on the quality of life. In the third session, explanations will be given about communication with God through worship, communication with nature, strengthening a positive attitude towards oneself. In the fourth session, you will learn about accepting your weaknesses and getting rid of negative intellectual and behavioral traits and trying to replace positive traits with negative traits, learning and spiritual belief, and deciding on spiritual growth. The fifth session will be about mental and environmental space for spiritual growth, and the last session will be about empowerment to solve the problems of oneself and others, continuous self-evaluation under the supervision of a spiritual individual, and finally a summary will be made. In-person training sessions with lectures, PowerPoint presentations, questions and answers, expression of experiences related to the topic of the meeting will be between the researcher and the patient caregivers. At the end, a training booklet containing the topics presented will be given to the research units. Intervention 2: Control group: No special intervention will be done and the program will be done routinely and commonly in the wards. At the end of the research,  the necessary information and educational program will be given to this group and their families in the form of an educational pamphlet.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sahar Fakhraei Azad Titkanlo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad School of Nursing and Midwifery, Ibn Sina</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>fakhraeias961@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Seyed Mousa Mahdizadeh Taraghdar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad School of Nursing and Midwifery, Ibn Sina St.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>mahdizadehm@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>"Be the first family members"
"At least have a primary education"
"Be 18 years old"
"Understand and speak Persian language"
"Have Interest and desire to participate in the study "</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>"Have a history of use psychotropic drugs in the past 2 months"
"Having a history of stress-related accidents in the last 6 months "
"Taking care of another person at the same time "
"Having visual and hearing problems "
"Activity in medical professions "
"History of receiving training in the field of anxiety and self-efficacy"</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>125/1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>بیماری تصلب شرایین قلب، کرونری(شریان)، آتروم، آترواسکلروزیس، بیماری اسکلروزیس</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention includes a spiritual care training program based on the spiritual strategies of Richards and Bergin, which will be theoretically and practically implemented for family caregivers of patients undergoing coronary artery bypass graft surgery. This training program will be done in 6 face-to-face sessions for 60-45 minutes daily. The first session will explain the objectives of the research and the importance of the curriculum and spiritual care. The second session explains the spirituality and mission of the chosen people and its impact on the quality of life. In the third session, explanations will be given about communication with God through worship, communication with nature, strengthening a positive attitude towards oneself. In the fourth session, you will learn about accepting your weaknesses and getting rid of negative intellectual and behavioral traits and trying to replace positive traits with negative traits, learning and spiritual belief, and deciding on spiritual growth. The fifth session will be about mental and environmental space for spiritual growth, and the last session will be about empowerment to solve the problems of oneself and others, continuous self-evaluation under the supervision of a spiritual individual, and finally a summary will be made. In-person training sessions with lectures, PowerPoint presentations, questions and answers, expression of experiences related to the topic of the meeting will be between the researcher and the patient caregivers. At the end, a training booklet containing the topics presented will be given to the research units.</i_keyword>
      <i_keyword>Control group: No special intervention will be done and the program will be done routinely and commonly in the wards. At the end of the research,  the necessary information and educational program will be given to this group and their families in the form of an educational pamphlet.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety score in Beck questionnaire. Timepoint: Measurement of anxiety at the beginning of the study (before the intervention), immediately and 4 weeks after the intervention. Method of measurement: Beck Anxiety Inventory.</prim_outcome>
      <prim_outcome>Self-efficacy score on the general self-efficacy scale. Timepoint: Measurement of self-efficacy at the beginning of the study (before the start of the study), immediately and 4 weeks after the intervention. Method of measurement: General Self-Efficacy 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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-18</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Central Building of Razavi Khorasan University of Medical Sciences, Daneshgah Ave, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
