<?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>IRCT20190727044347N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-18</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>the effect of active cycle breathing technique on pain, anxiety and blood oxygen saturation of patients undergoing coronary artery bypass graft (CABG)</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of active cycle breathing technique on pain, anxiety and blood oxygen saturation of patients undergoing coronary artery bypass graft (CABG)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>76</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69954</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After selecting eligible individuals to participate in the study based on inclusion criteria, these individuals will be assigned to two study groups based on double randomized permutation block with foursome blocks.
The random list is generated by a statistician using "Random Allocation" software.  Foursome blocks are the combination of different status such as: ABBA, BAAB, BABA, ABAB, BBAA, AABB. Using random list that is generated by computer,19 blocks will be selected to forme the two study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>patients undergoing coronary artery bypass graft (CABG).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:In the intervention group, breathing exercises are taught to the patients one day before the surgery by the researcher or the researcher's assistant. From the second day after the surgery and extubation, in the morning and evening shifts, the patients are encouraged to use incentive spirometry as a routine care. They also practice and implement the active cycle of breathing technique. This technique is performed in three stages; The first step is breathing control. At this stage, breathing is done slowly through the nose. If it is not possible for the patient to breathe through the nose, it is done through the mouth with pursed lips. During this stage, the patient is encouraged to keep his peace by closing his eyes and keeping himself away from any tension. The second step is to practice expanding the chest wall to provide airflow in the small airways. At this stage, air flows deeply, slowly and continuously through the nose into the lungs, so that the chest wall expands. The air is held for 2 to 3 seconds and then slowly exhaled through the mouth. This step is repeated 3 times. The final stage is the coughing stage and an integral part of this technique. In this stage, coughing is done through the mouth and throat. For this purpose, the patient takes a deep breath with the mouth open and with the help of respiratory muscles and then coughs. Active breathing cycle technique will be perform from the day after extubation of each patient in two days and in two shifts, morning and evening. Each time will be 3 sessions and each session will last for 10 minutes with a 15 minute break between them. In addition to the active breathing cycle technique, the patients in the intervention group will receive routine care including the use of an incentive spirometer. The level of anxiety, pain and arterial blood oxygen saturation will be assessed by the researcher or research assistant once before the intervention and then after each time the active breathing cycle technique is performed. Intervention 2: Control group:In the control group, patients receive the usual care, which includes the use of an incentive spirometer, according to the hospital routine. Breathing with a spirometer takes 10 to 20 deep breaths in each shift; This breathing is done in such a way that after the end of inhalation, the patient holds his breath for three seconds and by removing the device, exhales slowly through the mouth. This breathing exercise is performed in every shift until the patient is discharged. It is done sitting or semi-sitting, and after performing this technique, the level of anxiety, pain, and oxygen saturation of the arterial blood of the patients is measured from the day after the extubation of each patient in two days and in two shifts, morning and evening, by the researcher or the researcher's assistant.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Shirazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery (SA), Namazi Square</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71393613119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>shirazi_1393@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Shirazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery (SA), Namazi Square</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>shirazi_1393@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age above 18 years
Candidate for coronary artery bypass surgery according to physician's diagnosis
Not having a known history of severe respiratory and lung disease
Ability to perform breathing exercises and use the active cycle of breathing
No previous history of open heart surgery
Not having a history of known mental illness or under treatment with anti-anxiety and sedative drugs before surgery</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to stay in the study
Occurrence of critical complications after surgery including shock, critical hypertension crisis, cardiac tamponade
The occurrence of dangerous dysrhythmias such as atrial fibrillation and ventricular tachycardia
Mechanical ventilation for more than 48 hours after surgery
The need for reoperation during the hospitalization period</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T82.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified complications of cardiac and vascular prosthetic devices, implants and grafts</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:In the intervention group, breathing exercises are taught to the patients one day before the surgery by the researcher or the researcher's assistant. From the second day after the surgery and extubation, in the morning and evening shifts, the patients are encouraged to use incentive spirometry as a routine care. They also practice and implement the active cycle of breathing technique. This technique is performed in three stages; The first step is breathing control. At this stage, breathing is done slowly through the nose. If it is not possible for the patient to breathe through the nose, it is done through the mouth with pursed lips. During this stage, the patient is encouraged to keep his peace by closing his eyes and keeping himself away from any tension. The second step is to practice expanding the chest wall to provide airflow in the small airways. At this stage, air flows deeply, slowly and continuously through the nose into the lungs, so that the chest wall expands. The air is held for 2 to 3 seconds and then slowly exhaled through the mouth. This step is repeated 3 times. The final stage is the coughing stage and an integral part of this technique. In this stage, coughing is done through the mouth and throat. For this purpose, the patient takes a deep breath with the mouth open and with the help of respiratory muscles and then coughs. Active breathing cycle technique will be perform from the day after extubation of each patient in two days and in two shifts, morning and evening. Each time will be 3 sessions and each session will last for 10 minutes with a 15 minute break between them. In addition to the active breathing cycle technique, the patients in the intervention group will receive routine care including the use of an incentive spirometer. The level of anxiety, pain and arterial blood oxygen saturation will be assessed by the researcher or research assistant once before the intervention and then after each time the active breathing cycle technique is performed.</i_keyword>
      <i_keyword>Control group:In the control group, patients receive the usual care, which includes the use of an incentive spirometer, according to the hospital routine. Breathing with a spirometer takes 10 to 20 deep breaths in each shift; This breathing is done in such a way that after the end of inhalation, the patient holds his breath for three seconds and by removing the device, exhales slowly through the mouth. This breathing exercise is performed in every shift until the patient is discharged. It is done sitting or semi-sitting, and after performing this technique, the level of anxiety, pain, and oxygen saturation of the arterial blood of the patients is measured from the day after the extubation of each patient in two days and in two shifts, morning and evening, by the researcher or the researcher's assistant</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: From the second day after surgery and extubation, once before starting the intervention and then after performing each phase of the active breathing cycle technique. Method of measurement: visual analoge of scale pain.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: From the second day after surgery and extubation, once before starting the intervention and then after performing each phase of the active breathing cycle technique. Method of measurement: Spielberger questionnaire.</prim_outcome>
      <prim_outcome>Oxygen saturation of arterial blood. Timepoint: From the second day after surgery and extubation, once before starting the intervention and then after performing each phase of the active breathing cycle technique. Method of measurement: Pulse oximetry device.</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>2023-06-17</approval_date>
        <contact_name>Research Ethics Committees of Schools of Nursing and Midwifery, Management and Medical Information s</contact_name>
        <contact_address>Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd. Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
