<?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>IRCT20190405043164N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-06</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>"The effect of multimedia rehabilitation education on self-efficacy, perception of heart disease and biomarkers in patients undergoing coronary intervention."</public_title>
      <acronym></acronym>
      <scientific_title>"The effect of cardiac rehabilitation based on multimedia on self-efficacy, illness perception and cardiac biomarkers in patients undergoing per cutaneous coronary intervention referring to hospitals affiliated to Shiraz University of Medical Sciences</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44814</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Patients are divided into two groups of 35 according to the regular allocation technique. First, by simple randomization, the first patient referred from the sealed envelope removes the control or intervention word in the target group, and this is done by hiding the patient. The patient will be placed in the opposite group in each follow-up group. Other subsequent clients are also included in the intervention and control groups as one. The randomization unit is the patient and the construction is in random order, Blinding description: Patients are blinded by the following methods:
Patients referring to the intervention and control groups will be randomly assigned to the intervention and control groups based on the systematic random allocation technique; They don't have patients.
 The blinding of the study evaluator was done as follows:
Principal Investigator آوری Data collectors and people preparing the paper are not aware of patients in the control and intervention groups.
The study information and telephone fallout are only available to the intervention group. The consultation is based on the needs of patients in the intervention group and the control group does not have information about the content of the study and telephone phonoop and consultation. Obviously, after one month and evaluation of the patients in the control group, training is provided to the control group according to their needs and study information.</study_design>
      <phase>N/A</phase>
      <hc_freetext>coronary artery disease rehabilitation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients who received multimedia illness perception and self-efficacy during 10-sessions (each on 20 min) in addition to routine rehabilitation training, after one month by blood sampling, changes in inflammatory factors, and by the ((B-IPQ )Questionnaire and  Sullivan's self-efficacy Questionnaire changes in their illness perceptions  and self-efficacy exams. Intervention 2: Control group: Patients who receive only routine rehabilitation training and practice.</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:
Only part of the data, such as information about the main outcome or the like, can be shared.

When:
Start of course 6 months after the article is published

To whom:
Employed in academic and scientific institutions

Conditions:
The data will be accessible for similar scientific research and with respect to the rights of early researchers

Where to obtain:
Email address, or website, and phone numbers

How to obtain:
Contact Fred Mosul by email sarafadaei56@yahoo.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rakhshan.Mahnaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Fatemeh School of Nursing and Midwifery, Namazi Hospital, Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۳۳۶ - ۷۱۳۴۸</zip>
        <telephone>00987132305410-19</telephone>
        <email>mzrakhshan@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rakhshan.Mahnaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Fatemeh School of Nursing and Midwifery, Namazi Hospital, Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۳۳۶ - ۷۱۳۴۸</zip>
        <telephone>00987132305410-19</telephone>
        <email>mzrakhshan@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with coronary artery intervention
Willingness to participate in the research
Access the computer and have the ability to use a CD on a computer for multimedia use
Have normal hearing, vision and mental power to communicate with the researcher or patient's diagnosis
No doctor's diagnosis of mental illness and acute cognitive impairment
Access to the phone after discharge</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Uncontrolled hypertension, resting systole greater than 180 mm Hg or diastole greater than 110 mm Hg
Clear aortic stenosis smaller than 1cm detected.
Uncontrolled ventricular or atrial arrhythmia and grade 3 block with no pacemaker diagnosed.
unrecovered heart failure that has been diagnosed.
metabolic diseases such as acute thyroiditis, hypokalaemia, hyperkalemia, uncontrolled diabetes, and fever or acute systemic disease that have been diagnosed.
Severe orthopedic problems and severe musculoskeletal problems that impede activity.
Diagnosed  chronic mental illness or cognitive impairment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: Patients who received multimedia illness perception and self-efficacy during 10-sessions (each on 20 min) in addition to routine rehabilitation training, after one month by blood sampling, changes in inflammatory factors, and by the ((B-IPQ )Questionnaire and  Sullivan's self-efficacy Questionnaire changes in their illness perceptions  and self-efficacy exams</i_keyword>
      <i_keyword>Control group: Patients who receive only routine rehabilitation training and practice.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Inflammatory Factors with Neutrophil; Eosinophil and platlet Checkpoint. Timepoint: 30days. Method of measurement: CBC quantifier.</prim_outcome>
      <prim_outcome>Self-efficacy score on Sullivan questionnaire. Timepoint: 30days. Method of measurement: Sullivan questionnaire.</prim_outcome>
      <prim_outcome>Illness perception score  in B-IPQ questionnaire. Timepoint: 30days. Method of measurement: B-IPQ 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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-28</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>University of Medical Sciences,Zand ave,Shiraz Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
