<?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>IRCT201411097225N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-12-15</date_registration>
      <primary_sponsor>Investigator</primary_sponsor>
      <public_title>The effect of rhythmic breathing  on Acute Coronary Syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The effect of rhythmic breathing  on chest pain and cardiorespiratory parameters   Acute Coronary Syndrome patients admitted at CCU</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>112</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7662</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Acute Coronary Syndrome. Condition 2: Acute Coronary Syndrome. Condition 3: Acute Coronary Syndrome. Condition 4: Acute Coronary Syndrome. Condition 5: Acute Coronary Syndrome. Condition 6: Acute Coronary Syndrome. Condition 7: Acute Coronary Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group will do the rhythmic breathing for twenty minutes every five minutes once and it will take a minute and during their breathing will focus only on entering and leaving air. In this way that the patient will be supine state with eyes closed and with counting numbers 1, 2 and 3 will enter air through the nose into the lungs, then by counting 1, 2 and 3 will keep the air in their lungs and finally, by counting 1, 2 and 3 will out the air through the mouth. Intervention 2: In control group, the intervention will not take place except routine treatments.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Narges Saber</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gonabad University of Medical Sciences, Asian road, Gonabad, Khorasan Razavi, Iran</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 5722 3514</telephone>
        <email>n.saber@gmu.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Narges Saber</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gonabad University of Medical Sciences, Asian road, Gonabad, Khorasan Razavi, Iran</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 5722 3514</telephone>
        <email>n.saber@gmu.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Volunteer for research; ACS definitive diagnosis by the cardiologist; Lack of critical state of health (no cardiac dysrhythmia, hemodynamic and peripheral capillary oxygen saturation less than 80%) licensed clinician; Non-smoking; Lack of alcoholism and drug; Lack of respiratory diseases, gastrointestinal, diabetes and mental recognized and diagnosed by a physician; Age between 15-85 years&#13;
Exclusion criteria: Lack of satisfaction for cooperation; Create a life-threatening situation; The creation of any intervening circumstances that made it impossible to continue</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>92 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I20.0</hc_code>
      <hc_code>I21.0</hc_code>
      <hc_code>I21.1</hc_code>
      <hc_code>I21.2</hc_code>
      <hc_code>I21.3</hc_code>
      <hc_code>I21.4</hc_code>
      <hc_code>I21.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unstable angina</hc_keyword>
      <hc_keyword>Acute transmural myocardial infarction of anterior wall</hc_keyword>
      <hc_keyword>Acute transmural myocardial infarction of inferior wall</hc_keyword>
      <hc_keyword>Acute transmural myocardial infarction of other sites</hc_keyword>
      <hc_keyword>Acute transmural myocardial infarction of unspecified site</hc_keyword>
      <hc_keyword>Acute subendocardial myocardial infarction</hc_keyword>
      <hc_keyword>Acute myocardial infarction, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group will do the rhythmic breathing for twenty minutes every five minutes once and it will take a minute and during their breathing will focus only on entering and leaving air. In this way that the patient will be supine state with eyes closed and with counting numbers 1, 2 and 3 will enter air through the nose into the lungs, then by counting 1, 2 and 3 will keep the air in their lungs and finally, by counting 1, 2 and 3 will out the air through the mouth.</i_keyword>
      <i_keyword>In control group, the intervention will not take place except routine treatments.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Chest pain. Timepoint: Before and during 12 hours after intervention. Method of measurement: McGill pain scale.</prim_outcome>
      <prim_outcome>Systolic and diastolic blood pressure. Timepoint: Before and during 12 hours after intervention. Method of measurement: Monitoring.</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: Before and during 12 hours after intervention. Method of measurement: Monitoring.</prim_outcome>
      <prim_outcome>Respiratory rythme. Timepoint: Before and during 12 hours after intervention. Method of measurement: Monitoring.</prim_outcome>
      <prim_outcome>Pulse rate. Timepoint: Before and during 12 hours after intervention. Method of measurement: Monitoring.</prim_outcome>
      <prim_outcome>Pulse rythme. Timepoint: Before and during 12 hours after intervention. Method of measurement: Electrocardiogram.</prim_outcome>
      <prim_outcome>Peripheral capillary oxygen saturation. Timepoint: Before and during 12 hours after intervention. Method of measurement: Pulse oxymeter.</prim_outcome>
      <prim_outcome>The need for drug. Timepoint: Before and during 12 hours after intervention. Method of measurement: Patient pan card.</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>Investigator</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-05-22</approval_date>
        <contact_name>Gonabad University of Medical Sciences</contact_name>
        <contact_address>Gonabad University of Medical Sciences, Asian road, Gonabad, Khorasan Razavi, Iran Gonabad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
