<?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>IRCT201502049422N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-03-15</date_registration>
      <primary_sponsor>Urima Medical Sience University</primary_sponsor>
      <public_title>Effects of cold on the pain</public_title>
      <acronym></acronym>
      <scientific_title>Assessment affection of cold gel pack application on the sternal incision and pleural chest tube insertion site on the pulmonary function and pain due to coughing and deep breathing in coronary artery bypass graft surgery patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/9941</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Pain in patients undergoing coronary artery surgery. Condition 2: pulmonary function tests.</hc_freetext>
      <i_freetext>Intervention 1: In this study, the cooling gel pack with dimensions (10 × 25 cm) that is placed at room temperature and the timer is set for 20 minutes for the control group. Then, gel pack is placed in the dressing on the sternum incision site and around the pleural chest tube. A pillow or folded sheet will be given to the patient to support and immobilize the wound site before coughing or deep breathing. Gel pack is removed in 20 minutes and head of the bed elevated to 45-90 degrees for coughing and deep breathing.&#13;
Pain intensity will be measured by a researcher using numerical pain scale, before and after applying gel pack at the end of coughing and deep breathing in the control group. The lung volumes are measured by using spirometry three times; before surgery, before and after applying the gel pack and coughing and deep breathing. Data will be collected in the afternoon of the first day after the operation. Intervention 2: In this study, the cooling gel pack with dimensions (10 × 25 cm) that has been frozen for at least one hour (reaching a pack’s temperature between 0 to - 5°C) is  removed from the freezer and the timer is set for 20 minutes in the intervention group. Then, gel pack is placed in the dressing on the sternum incision site and around the pleural chest tube. A pillow or folded sheet will be given to the patient to support and immobilize the wound site before coughing or deep breathing. Gel pack is removed in 20 minutes and head of the bed elevated to 45-90 degrees for coughing and deep breathing.&#13;
Pain intensity will be measured by a researcher using numerical pain scale, before and after applying the gel pack at the end of coughing and deep breathing in the intervention group. The lung volumes are measured by using spirometry three times; before surgery, before and after applying the gel pack, and coughing and deep breathing. Data will be collected in the afternoon of the first day after the operation.</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>Noorellahi Davod</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Madani hospital, In front of Research and Development complex of University, university street, Tabriz, East Azarbaijan</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 3335 7771</telephone>
        <email>msc_ccn@yahoo.com</email>
        <affiliation>Madani hospital, Tabriz Medical Science University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Feizi Aram</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Nazlo complex, 11 km Serov, Urmia, West Azarbaijan</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 44 3275 4961</telephone>
        <email>aramfeizi@yahoo.com</email>
        <affiliation>Urmia Nursing and Midwifery School</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A) Inclusion Criteria&#13;
1-  The patient consent to participate in the study.&#13;
2-  The patient is over 40 years old.&#13;
3-  The patient is able to read and write.&#13;
4-  The patient can  speak Farsi and Turkish.&#13;
5-  The patient orient to person, place and time.&#13;
6-  The patient is able t use pain scale.&#13;
7-  The patient has been underwent coronary artery bypass surgery ( with or without valve replacement ) with median sternutomy located.&#13;
&#13;
B) Exclusion criteria&#13;
1- The patient has a history of allergy or sensitivity to cold.&#13;
2- The patient has a history of Raynaud 's syndrome , sickle cell anemia , Cryoglobulinemia , diabetes and delirium.&#13;
3- The patient has severe visual, hearing and speech  impairment.&#13;
4- The patient  is connected to a ventilator at the time of data collection.&#13;
5- The patient has been ill at the time of data collection.&#13;
6- The patient has postoperative complications such as infection , bleeding , uncontrolled atrial fibrillation and opening the wound edges.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>100 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R07.1</hc_code>
      <hc_code>R94.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chest pain on breathing</hc_keyword>
      <hc_keyword>Abnormal results of pulmonary function studies</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>In this study, the cooling gel pack with dimensions (10 × 25 cm) that is placed at room temperature and the timer is set for 20 minutes for the control group. Then, gel pack is placed in the dressing on the sternum incision site and around the pleural chest tube. A pillow or folded sheet will be given to the patient to support and immobilize the wound site before coughing or deep breathing. Gel pack is removed in 20 minutes and head of the bed elevated to 45-90 degrees for coughing and deep breathing.&#13;
Pain intensity will be measured by a researcher using numerical pain scale, before and after applying gel pack at the end of coughing and deep breathing in the control group. The lung volumes are measured by using spirometry three times; before surgery, before and after applying the gel pack and coughing and deep breathing. Data will be collected in the afternoon of the first day after the operation.</i_keyword>
      <i_keyword>In this study, the cooling gel pack with dimensions (10 × 25 cm) that has been frozen for at least one hour (reaching a pack’s temperature between 0 to - 5°C) is  removed from the freezer and the timer is set for 20 minutes in the intervention group. Then, gel pack is placed in the dressing on the sternum incision site and around the pleural chest tube. A pillow or folded sheet will be given to the patient to support and immobilize the wound site before coughing or deep breathing. Gel pack is removed in 20 minutes and head of the bed elevated to 45-90 degrees for coughing and deep breathing.&#13;
Pain intensity will be measured by a researcher using numerical pain scale, before and after applying the gel pack at the end of coughing and deep breathing in the intervention group. The lung volumes are measured by using spirometry three times; before surgery, before and after applying the gel pack, and coughing and deep breathing. Data will be collected in the afternoon of the first day after the operation</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: before and 20 minutes after intervention. Method of measurement: numeric pain scale.</prim_outcome>
      <prim_outcome>Pulmonary function results. Timepoint: before of operation /before of use of ice packed/ 20 minutes after use of ice packed. Method of measurement: spirometry.</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>Urima Medical Sience University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-01-26</approval_date>
        <contact_name>Tabriz Medical Science University</contact_name>
        <contact_address>Central Building of Medical science, Golgasht Avenue, Azadi Street, Tabriz, East Azarbaijan Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
