<?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>IRCT20181123041729N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-08</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of rhythmic breathing on pain intensity and anxiety in patients after coronary artery bypass graft surgery</public_title>
      <acronym></acronym>
      <scientific_title>The effect of rhythmic breathing on pain intensity and anxiety in patients after coronary artery bypass graft surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>102</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35547</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The method of assigning intervention to individuals was randomized and random blocked blocks with block size 4 (using the table for random permutations). The randomization list is provided by a statistic specialist. Blocking is usually used to create a balance in the number of specimens assigned to each of the studied groups. In this trial, there were two groups of 4 blocks consisting of 2 participants in the intervention group and 2 participants in the control group. The intervention used in this study according to a randomized list is provided by a person outside the study who is not aware of the research objectives and will be assigned a different code to the closed envelopes and will be allocated to any disease that is included in the study. In this way, a number of envelopes with an aluminum sleeve (for the lack of clarity of the contents of the envelopes) are prepared and each random sequence created on the card is recorded and the cards are inserted into the envelopes respectively. In order to maintain a random sequence, the numbering of envelopes on the outer surface is done in the same order. Finally, the door of the envelopes is pasted and placed in the box, respectively. At the time of the registration of the participants, one of the envelopes of the letter was opened in accordance with the order of the entry of the eligible participants, and the group allocated to it Participant will be revealed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coronary artery Bypass Graft Patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the ICU section, the patient is asked to measure rhythmic pain on the first day of operation (after extubation and alertness of the patient) and on the second and third days of the operation, which will allow rhythmic breathing for 20 minutes every 5 minutes once and every time It takes one minute to complete the training three times a day. Every day before and after the intervention, the pain assessment questionnaire will be completed by the researcher and interview method. To measure the amount of anxiety, the second day of the operation requires patients to take the intervention three times a day according to the procedure described above. Before and after the intervention, the Spielberger anxiety inventory will be completed by the researcher. Intervention 2: Control group: No intervention will be performed. During the first, second and third day, the intensity of pain will be measured and the second day of anxiety will be measured.</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>Samereh Nasirnezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Medical Sciences, Jundishapur University of Medical Sciences, Faculty of Nursing and Midwifery</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715749</zip>
        <telephone>+98 613311159</telephone>
        <email>nasirnejad.s@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samereh Nasirnezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Medical Sciences, Jundishapur University of Medical Sciences, Faculty of Nursing and Midwifery</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715749</zip>
        <telephone>+98 613311159</telephone>
        <email>nasirnejad.s@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients undergoing coronary artery bypass graft surgery
Age of at least 30 and maximum 75 years
Not having a history of taking sedative medicines and antidepressants
The absence of known and diagnosed psychiatric illnesses by the physician</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>having a history of taking sedative medicines and antidepressants
The diagnosis of mental illness is documented</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerotic heart disease of native coronary artery</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 ICU section, the patient is asked to measure rhythmic pain on the first day of operation (after extubation and alertness of the patient) and on the second and third days of the operation, which will allow rhythmic breathing for 20 minutes every 5 minutes once and every time It takes one minute to complete the training three times a day. Every day before and after the intervention, the pain assessment questionnaire will be completed by the researcher and interview method. To measure the amount of anxiety, the second day of the operation requires patients to take the intervention three times a day according to the procedure described above. Before and after the intervention, the Spielberger anxiety inventory will be completed by the researcher.</i_keyword>
      <i_keyword>Control group: No intervention will be performed. During the first, second and third day, the intensity of pain will be measured and the second day of anxiety will be measured.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: On the first day of operation (after extubation and alertness of the patient) and on the second and third days of operation, every time before and after the intervention. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Speilberger Anxiety scale. Method of measurement: The second day of surgery before and after the intervention.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The amount of analgesic use. Timepoint: On the first, second and third days of action. Method of measurement: Through the checklist.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-11-03</approval_date>
        <contact_name>Ethics committee of Ahvaz University of Medical Sciences</contact_name>
        <contact_address>City university, Assistant Professor of Research and Technology Development, Ahvaz, Ground floor Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
