<?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>IRCT20190805044442N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-01</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>The effect of the first phase of cardiac rehabilitation in cardiac surgery patients</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of First phase of cardiac Rehabilitation on Illnes Perception and Health Literacy of patients under coronary artery bypass graft of</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-11-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41301</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Block random method was used to select the subjects in the control and intervention groups. According to the sample size, 30 patients were in the control group and 30 in the intervention group.
Questionnaires were completed by people who were eligible for the study. Then they were randomly assigned into intervention and control groups. Sample allocation was performed in both groups randomly. And after the number of people in each block reached five. Sampling from another group was repeated. Up to 30 in each group. Six blocks of five were created in each group. A total of 68 patients were included in the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cardiac rehabilitation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The first phase of cardiac rehabilitation was performed in 4 sessions of 30 minutes in a multi-disciplinary form for patients in the intervention group .Including training by a rehabilitation nurse to help shape the patient's understanding of coronary artery bypass grafting, counseling by a nutrition expert, preoperative exercise training, and post-surgery coronary artery bypass graft physicians, as well as patient group education with family members After surgery, a rehab nurse was done.The health literacy and perception of the disease were analyzed in two steps before surgery and one month after the operation using SPSSv22 software, Chi-square, t-student and analysis of co variance and variance were analyzed. Intervention 2: Control group: Control group:The intervention in the control group only included routine hospital training .One month after the operation, they received a pamphlet of training that was provided by the intervention group in response to a questionnaire on illness and health literacy.Perceived status of disease and health literacy, in two stages before surgery and one month after operation by SPSSv22 software, using chi-square, independent and paired t-test and analysis of covariance and variance. Was analyzed.</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:
All potential data can be shared after unidentifiable people.

When:
"Start of access period 6 months after printing results"

To whom:
The data will be available only to researchers working in academic and scientific institutions.

Conditions:
I will decide whether to use the data or documentation provided by me in relation to the type of study and the conditions of its use.I will agree with the caller at the same time.

Where to obtain:
Fahimeh Reihani Contact Number: 09125627510
 Fahimeh Reihani Email Address: fahima.reyhani8888@gmail.com

How to obtain:
Applicants can receive the data after one month by phone or e-mail.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fahimeh Reyhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 39.2, Fourth Floor Unit 12,West-Ghalam Ave, 17  Shahin Villa St, Baghestan</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3193976917</zip>
        <telephone>+98 26 3432 9866</telephone>
        <email>fahima.reyhani8888@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fahimeh Reyhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 39.2, Fourth Floor Unit 12.,   West-Ghalam Ave., 17  Shahin Villa St ., Baghestan</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3193976917</zip>
        <telephone>+98 26 3432 9866</telephone>
        <email>fahima.reyhani8888@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients waiting for coronary artery bypass graft surgery; at least two days have passed since their angography.
Consent to participate in the research
No neurovascular diseases (according to the patient's own medical records)
First time experience coronary artery bypass graft surgery
Be vigilant (aware of location, time and person).
Surgery in the operating room has undergone a routine procedure (coronary artery bypass grafting only)
There are no postoperative complications such as extensive drainage, pneumothorax, tamponade, dangerous arrhythmia, and so on.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>In case of death of sample
During the study, the patient may experience acute complications from surgery.
If the condition worsens (re-entry to the operating room)
• In case of incomplete completion of the questionnaire of dissatisfaction with continuing to participate in the research at each stage</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z50.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cardiac rehabilitation</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 first phase of cardiac rehabilitation was performed in 4 sessions of 30 minutes in a multi-disciplinary form for patients in the intervention group .Including training by a rehabilitation nurse to help shape the patient's understanding of coronary artery bypass grafting, counseling by a nutrition expert, preoperative exercise training, and post-surgery coronary artery bypass graft physicians, as well as patient group education with family members After surgery, a rehab nurse was done.The health literacy and perception of the disease were analyzed in two steps before surgery and one month after the operation using SPSSv22 software, Chi-square, t-student and analysis of co variance and variance were analyzed.</i_keyword>
      <i_keyword>Control group: Control group:The intervention in the control group only included routine hospital training .One month after the operation, they received a pamphlet of training that was provided by the intervention group in response to a questionnaire on illness and health literacy.Perceived status of disease and health literacy, in two stages before surgery and one month after operation by SPSSv22 software, using chi-square, independent and paired t-test and analysis of covariance and variance. Was analyzed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Comparison illness perception score between intervention and control groups. Timepoint: Measurement of illness perception score before intervention and one month after hospital discharge. Method of measurement: Illness Perception Questionnaire.</prim_outcome>
      <prim_outcome>Measure health literacy score before intervention and one month after hospital discharge. Timepoint: Measure health literacy score before intervention and one month after hospital discharge. Method of measurement: Health Literacy for Iranian Adults 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>Tehran University of Social Welfare and Rehabilitation Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-04</approval_date>
        <contact_name>Ethics Committee for Research of University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>Evin, Student Boulevard, Koodakyar Dead End tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
