<?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>IRCT20191028045267N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-12</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>"Investigating the effect of incentive spirometry on hemodynamic parameters of patients undergoing coronary artery bypass grafting surgery""The effect of deep breathing exercises on hemodynamic parameters of patients undergoing coronary artery bypass grafting surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of incentive spirometry and deep breathing exercises on hemodynamic parameters of patients undergoing coronary artery bypass grafting surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43365</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be divided into two groups of breathing exercises (n = 20) and incentive spirometry (n = 20) via permuted-block randomization.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients Candidate for Coronary Artery Bypass Grafting.</hc_freetext>
      <i_freetext>Intervention 1: Control group: incentive spirometry (One day before surgery, patients in the incentive spirometry group were trained on how to use incentive spirometry to ensure that the researcher performed them correctly. Applying a spiral tube to the mouth, he/she inhaled inside the device in a sitting or semi-sitting posture, holding his/her breath for three seconds, and slowly exhaled by removing the device. Patients were asked that each time they increased breathing, they gradually took deeper breaths. This exercise was repeated for 10 deep breaths, every two hours at waking time. These interventions began one hour after the endotracheal tube was removed by the researcher’s supervision or her colleague’s and continued for up to three days after surgery. Hemodynamic parameters were measured and recorded on the first, second, and third days postoperatively. Intervention 2: Breathing exercises (One day before surgery, patients in the breathing exercises group were trained on how to perform deep scheduled breathing exercises so that the researcher ensures it is performed accurately. Scheduled deep breathing exercises were trained such that a patient is in a sitting or semi-sitting posture, performing slow, deep breathing through the nose, while simultaneously placing his/her hands on the chest to relieve pain and breathing more easily, and after inhalation, holds his/her breath for three seconds. Then he/she exhales through the mouth while the lips and the abdominal muscles are squeezed. He/she must repeat this exercise for a ten times every two hours at waking time. These interventions began one hour after the endotracheal tube was removed by a researcher or her colleague and continued for up to three days after surgery. Hemodynamic parameters were measured and recorded on the first, second, and third days postoperatively.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Zerang</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 18,Yas Ave, Qafari Ave</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9719866838</zip>
        <telephone>+98 56 3234 1503</telephone>
        <email>fateme.zerang2018@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Zerang</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 18, Yas Ave, Qafari Ave</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9719866838</zip>
        <telephone>+98 56 3234 1503</telephone>
        <email>fateme.zerang2018@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>No suffering of cognitive neuromuscular disorders
Non-emergency surgery
Ability to perform breathing exercises and to use incentive spirometry
Willingness to participate in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Re-surgery due to possible complications
Cognitive and neurological complications after surgery
Severe hemodynamic disorders (e.g., severe hypo- and hypertension, shock)
Severe lung disease (such as chronic obstructive pulmonary disease)
Kidney dysfunction</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>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: incentive spirometry (One day before surgery, patients in the incentive spirometry group were trained on how to use incentive spirometry to ensure that the researcher performed them correctly. Applying a spiral tube to the mouth, he/she inhaled inside the device in a sitting or semi-sitting posture, holding his/her breath for three seconds, and slowly exhaled by removing the device. Patients were asked that each time they increased breathing, they gradually took deeper breaths. This exercise was repeated for 10 deep breaths, every two hours at waking time. These interventions began one hour after the endotracheal tube was removed by the researcher’s supervision or her colleague’s and continued for up to three days after surgery. Hemodynamic parameters were measured and recorded on the first, second, and third days postoperatively.</i_keyword>
      <i_keyword>Breathing exercises (One day before surgery, patients in the breathing exercises group were trained on how to perform deep scheduled breathing exercises so that the researcher ensures it is performed accurately. Scheduled deep breathing exercises were trained such that a patient is in a sitting or semi-sitting posture, performing slow, deep breathing through the nose, while simultaneously placing his/her hands on the chest to relieve pain and breathing more easily, and after inhalation, holds his/her breath for three seconds. Then he/she exhales through the mouth while the lips and the abdominal muscles are squeezed. He/she must repeat this exercise for a ten times every two hours at waking time. These interventions began one hour after the endotracheal tube was removed by a researcher or her colleague and continued for up to three days after surgery. Hemodynamic parameters were measured and recorded on the first, second, and third days postoperatively.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Arterial Oxygen Saturation in Two Groups (Incentive Spirometry and Respiratory Exercise). Timepoint: before surgery, before induction of anesthesia and on the first, second, and third days after surgery,. Method of measurement: A PC-66b pulse oximeter, made in China, was performed.</prim_outcome>
      <prim_outcome>Respiratory rate in two groups (incentive spirometry and breathing exercises). Timepoint: before surgery, before induction of anesthesia and on the first, second, and third days after surgery,. Method of measurement: Observing chest movements in a minute and counting it.</prim_outcome>
      <prim_outcome>Systolic and diastolic blood pressure in two groups (incentive spirometry and breathing exercises). Timepoint: Before surgery, before induction of anesthesia, and on the first, second, and third days after surgery. Method of measurement: As the instructions show, a mercury barometer with an appropriate armband size, while a patient is sitting on a comfortable chair with his/her hand on his/her heart, is measured twice in a 10-15 minute interval and the mean scores is recorded as an his/her blood pressure.</prim_outcome>
      <prim_outcome>Heart rate in two groups (incentive spirometry and breathing exercises). Timepoint: Before surgery, before induction of anesthesia, and on the first, second, and third days after surgery. Method of measurement: A PC-66b pulse oximeter, made in China, was performed.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-14</approval_date>
        <contact_name>Ethics Committee of the Islamic Azad University, Yazd Branch</contact_name>
        <contact_address>Shohaday-e-Gomnam Blvd., Safaeieh D.C., Yazd City, Yazd Province Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
