<?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>IRCT20200907048645N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-19</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Effect of guided reflection on self-care and medical adherence</public_title>
      <acronym></acronym>
      <scientific_title>Effect of guided reflection on self-care and medical adherence in patients undergoing Coronary Artery Bypass Graft</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>94</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50785</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The 4-volume block method is used to generate a random allocation sequence. Patients will be selected according to the criteria of the researcher and by sequential sampling method and will be randomly divided into two groups A and B. This means that a number of sealed envelopes are prepared, each containing an A or B code.  The researcher takes the desired envelope in the specified order and acts according to the group registered in the envelope. It is determined in which group each patient will be placed, Blinding description: In this study, data collectors and data analyzer and clinical caregivers are blinded and will not be aware that how individuals are assigned to groups. In this way, the data collector will be a trained expert nurse who does not know how patients are allocated. Participants and researchers are not blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>coronary artery bypass graft.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Guided reflection, which includes several stages, will be explained to the patients in the experimental group, and based on it and the questions that are asked in each stage, the person will discuss the situations and events that he/she has faced And expresses his positive and negative feelings about it and Steps are taken to better understand and plan for better performance in similar situations that are predicted in the future. Intervention 2: Control group:related to the control group, they will have routine trainings in the clinic and ward (including providing medical pamphlets and oral training by a doctor and nurse).</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>Elahe Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3th Floor, No 7, melal 11 Alley, Lesani St</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4819797519</zip>
        <telephone>+98 11 3323 2866</telephone>
        <email>elahe2941@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elahe Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3th Floor, No 7, melal 11 Alley, Lesani St</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4819797519</zip>
        <telephone>+98 11 3323 2866</telephone>
        <email>elahe2941@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>lack of experiencing CABG surgery before
Ability to communicate verbally
Between 20 to 60 years old</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with Cognitive impairment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.70</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerosis of coronary artery bypass graft(s), unspecified, with angina pectoris</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Guided reflection, which includes several stages, will be explained to the patients in the experimental group, and based on it and the questions that are asked in each stage, the person will discuss the situations and events that he/she has faced And expresses his positive and negative feelings about it and Steps are taken to better understand and plan for better performance in similar situations that are predicted in the future.</i_keyword>
      <i_keyword>Control group:related to the control group, they will have routine trainings in the clinic and ward (including providing medical pamphlets and oral training by a doctor and nurse).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self care. Timepoint: Self-care will be measured at the beginning of the study, before the intervention, and six weeks after the intervention. Method of measurement: Cardiac Patients' Self-Care Questionnaire Validated by Khodaminasab et al.</prim_outcome>
      <prim_outcome>Medical adherence. Timepoint: Medical adherence will be measured at the beginning of the study, before the intervention, and six weeks after the intervention. Method of measurement: Morisky medical adherence 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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-08</approval_date>
        <contact_name>Ethics committee of Shahrood University of Medical Sciences</contact_name>
        <contact_address>Shahrood medical univercity, 7 tir Sq Shahrood Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
