<?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>IRCT20150519022320N18</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-27</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effects of relaxation and meditation techniques on serum levels of IL-10, TGF-β, IL-6 and IFN-γ</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effects of relaxation and meditation techniques on serum levels of IL-10, TGF-β, IL-6 and IFN-γ  in the patients with Coronary Artery Disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34964</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: The sampling will be based on objective criteria for inclusion. After obtaining informed consent, subjects randomly to be divided into groups. By random numbers, each person is assigned a number. They were then randomly assigned to relaxation and meditation groups, Blinding description: Experiments are conducted by a researcher who does not know about the grouping of participants in the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Atherosclerotic heart disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: A relaxation program will be planned and implemented in seven stages for the relaxation group, the steps of which will be:1. Identify the muscles and muscle groups of the case, 2- Training on progressive muscle relaxation technique using its explanation and practical presentation by the researcher,3- Answering the patient's questions about the relaxation technique 4- Performing the technique by the researcher using an audio tape, or educational CD 5- Performing the technique by the patients along with the researcher, 6- Statement of difference in physical and mental feelings of samples after relaxation 7- Performing the technique by samples and under the supervision of the researcher. In relaxation, patients will be asked to first shrink and then loosen the muscles of the muscles of the foot to the muscles of the face, including 16 muscles. Patients relax their muscles by counting up to number 5 and then relaxing by counting up to 10.The same steps will be repeated for the legs, legs, thighs, abdomen, chest, hips, arms and forearms, arms, shoulders, neck, forehead, tongue and jaw, eyes and face until all of their bodies Loose integrated.At the same time, patients breathe deeply during relaxation. The state of choice for gradual relaxation is lying. The patient will perform this exercise until the difference between the contraction and the muscle tone is felt and expressed.In this way, the method will be taken and can take this method alone and using a tape. After ensuring the correct understanding and correctness of the procedure, audio cassettes and CDs will be provided to patients for the implementation of relaxation steps. And they spend three months (three times a week) one day in a row and for a half an hour under the supervision of the researcher (a total of 36 sessions). Intervention 2: Intervention group 2: To perform meditation, the patient is asked to be in a comfortable position and perform a deep inhale with 3 numbers and a deep exhalation with 4 numbers; Meditation for 8 weeks, 3 days a week, and 15 to 20 minutes per day in two steps in the morning and in the evening. Intervention 3: Control group: 30 people with coronary artery disease without any intervention. Blood samples are taken before and three months after the study.</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 Confidentiality of information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tayebeh mirzaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Parastar Ave.</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718796755</zip>
        <telephone>+98 34 3452 5900</telephone>
        <email>t.mirzaei@rums.ac.ir</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Kazemi Arababadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Parastar Ave.</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718796755</zip>
        <telephone>+98 34 3425 5900</telephone>
        <email>kazemi24@yahoo.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Known coronary artery disease (based on medical records)
Background in the CCU
Lack of history of mental illness or lack of use of psychoactive drugs
Desire to participate in the study
Lack of heart failure
Lack of autoimmune diseases, allergies and immune-related diseases
Age range 45 to 75 years</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic ischemic heart disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: A relaxation program will be planned and implemented in seven stages for the relaxation group, the steps of which will be:1. Identify the muscles and muscle groups of the case, 2- Training on progressive muscle relaxation technique using its explanation and practical presentation by the researcher,3- Answering the patient's questions about the relaxation technique 4- Performing the technique by the researcher using an audio tape, or educational CD 5- Performing the technique by the patients along with the researcher, 6- Statement of difference in physical and mental feelings of samples after relaxation 7- Performing the technique by samples and under the supervision of the researcher. In relaxation, patients will be asked to first shrink and then loosen the muscles of the muscles of the foot to the muscles of the face, including 16 muscles. Patients relax their muscles by counting up to number 5 and then relaxing by counting up to 10.The same steps will be repeated for the legs, legs, thighs, abdomen, chest, hips, arms and forearms, arms, shoulders, neck, forehead, tongue and jaw, eyes and face until all of their bodies Loose integrated.At the same time, patients breathe deeply during relaxation. The state of choice for gradual relaxation is lying. The patient will perform this exercise until the difference between the contraction and the muscle tone is felt and expressed.In this way, the method will be taken and can take this method alone and using a tape. After ensuring the correct understanding and correctness of the procedure, audio cassettes and CDs will be provided to patients for the implementation of relaxation steps. And they spend three months (three times a week) one day in a row and for a half an hour under the supervision of the researcher (a total of 36 sessions).</i_keyword>
      <i_keyword>Intervention group 2: To perform meditation, the patient is asked to be in a comfortable position and perform a deep inhale with 3 numbers and a deep exhalation with 4 numbers; Meditation for 8 weeks, 3 days a week, and 15 to 20 minutes per day in two steps in the morning and in the evening.</i_keyword>
      <i_keyword>Control group: 30 people with coronary artery disease without any intervention. Blood samples are taken before and three months after the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measuring the level of serum IL-6. Timepoint: Before the study and three months after the start of the study. Method of measurement: ELISA test.</prim_outcome>
      <prim_outcome>Measuring the level of serum IL-10. Timepoint: Before the study and three months after the start of the study. Method of measurement: ELISA test.</prim_outcome>
      <prim_outcome>Measuring the level of serum TGF-β. Timepoint: Before the study and three months after the start of the study. Method of measurement: ELISA test.</prim_outcome>
      <prim_outcome>Measuring the level of serum IFN-. Timepoint: Before the study and three months after the start of the study. Method of measurement: ELISA test.</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>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-20</approval_date>
        <contact_name>کمیته اخلاق در پژوهش دانشگاه علوم پزشکی رفسنجان</contact_name>
        <contact_address>بلوار امام علی،سازمان مرکزی سازمان مرکزی دانشگاه علوم پزشکی رفسنجان Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
