<?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>IRCT2015050622120N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-11-03</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Effect of deep and slow breathing on consequences of pain during arterial sheath removal in patients undergoing percutaneous coronary intervention</public_title>
      <acronym></acronym>
      <scientific_title>Effect of deep and slow breathing on consequences of pain during arterial sheath removal in patients undergoing percutaneous coronary intervention</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19160</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients undergoing coronary angioplasty.</hc_freetext>
      <i_freetext>Intervention 1: Patients in the intervention group admission is trained on how to take slow, deep breathing and 15 minutes  before leaving again in terms of learning and doing clean properly controlled technique. To perform this procedure the patient is asked to breathe and exhale ratio 4: 6 do. The training face to face and to protect the tail of the expiration of counting used. Patients from 5 minutes before removing the sheet for 15 minutes , deep breathing and relaxation techniques to do. Patients will be asked to close your eyes while performing these techniques on how to do breathing and focus, as well as a hand on the abdomen and the other hand on their chest. Patients are taught to breathe through the nose and exhale through the mouth counts one to four, and act and do by counting from one to six . To ensure the patient will be asked to learn the technique for 1 minute in the presence of the researcher. All sheet for 5 minutes after starting slow, deep breathing and took out the tail end. Intervention 2: In the control group, patients in the usual way and without the use of deep breathing and slow the sheet out.</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>Dr. Kobra Rahzani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid shiroodi Ave., Alamolhoda Ave.</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 86 3313 6055</telephone>
        <email>k.rahzani@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Kobra Rahzani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid shiroodi Ave., Alamolhoda Ave.</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 86 3313 6055</telephone>
        <email>k.rahzani@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients in the study are that have these criteria:&#13;
• For the first time undergoing coronary angioplasty, as well.&#13;
• Have the ability to learn.&#13;
• Has a mental disorder is not known, according to their relatives.&#13;
• Fluency in Farsi and is able to communicate.&#13;
• To participate in the study have written consent.&#13;
• Systolic blood pressure is less than 130 mmhg.&#13;
• any shortness of breath and breathing difficulties are clear.&#13;
• The absence of pain and complication of vascular puncture to remove the sheet. Patients who have the following conditions shall be excluded:&#13;
• Housing has received for any reason.&#13;
• Experience shortness of breath, irregular heart disease, congestive heart failure or heart attack is.&#13;
• Experiencing cardiac arrest is from respiratory or loss of consciousness.&#13;
• Be deterred from continuing to study.&#13;
• Fatal or transfer him to the operating room for emergency surgery any.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z95.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Status following coronary angioplasty NOS</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Patients in the intervention group admission is trained on how to take slow, deep breathing and 15 minutes  before leaving again in terms of learning and doing clean properly controlled technique. To perform this procedure the patient is asked to breathe and exhale ratio 4: 6 do. The training face to face and to protect the tail of the expiration of counting used. Patients from 5 minutes before removing the sheet for 15 minutes , deep breathing and relaxation techniques to do. Patients will be asked to close your eyes while performing these techniques on how to do breathing and focus, as well as a hand on the abdomen and the other hand on their chest. Patients are taught to breathe through the nose and exhale through the mouth counts one to four, and act and do by counting from one to six . To ensure the patient will be asked to learn the technique for 1 minute in the presence of the researcher. All sheet for 5 minutes after starting slow, deep breathing and took out the tail end.</i_keyword>
      <i_keyword>In the control group, patients in the usual way and without the use of deep breathing and slow the sheet out.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before the intervention, immediately after the intervention, 10 and 20 minutes after intervention. Method of measurement: Pain visual scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure. Timepoint: Before the intervention, immediately, 5,10,15,20 minutes later. Method of measurement: Digital Sphygmomanometer.</sec_outcome>
      <sec_outcome>Pulse Rate. Timepoint: Before the intervention, immediately, 5,10,15,20 minutes later. Method of measurement: Cardiac monitoring.</sec_outcome>
      <sec_outcome>Respiratory rate. Timepoint: Before the intervention, immediately, 5,10,15,20 minutes later. Method of measurement: Respiration monitoring.</sec_outcome>
      <sec_outcome>Bleeding. Timepoint: Immediately after the homeostasis, 4 and 24 hours later. Method of measurement: Observation.</sec_outcome>
      <sec_outcome>Hematoma. Timepoint: Immediately after the homeostasis, 4 and 24 hours later. Method of measurement: Observation and examination.</sec_outcome>
      <sec_outcome>Pseudoaneurism. Timepoint: Immediately after the homeostasis, 4 and 24 hours later. Method of measurement: Observation and examination and sonography.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-04-20</approval_date>
        <contact_name>Arak University of Medical Sciences</contact_name>
        <contact_address>Arak University of Medical Sciences, Sardasht Arak  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
