<?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>IRCT201205169664N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-06-06</date_registration>
      <primary_sponsor>Vice-chancellor for Research of Zanjan University of Medcial Sciences and Health Services</primary_sponsor>
      <public_title>The effectiveness of cold application in combination with Indomethacin suppository on chest tube removal pain undergone open heart surgery patients.</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of cold application in combination with Indomethacin suppository on chest tube removal pain undergone open heart surgery patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10236</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>chest tube removal pain.</hc_freetext>
      <i_freetext>Intervention 1: In Intervention  group 100 mg Indomethacin suppository will be  administered one hour before Chest tube removal. In intervention group a 4º c   cold pack will be placed on chest tube site  20 minutes before removing chest tube.  pain intensity  evaluated by the visual analog scale three times:20 minutes before, just after and 15 minutes after chest tube removal.&#13;
In controrl group:  100 mg Indomethacin suppository will be  administered one hour prior to Chest tube removal. In control  group same  cold pack with room tempreature (as placebo)  will be placed on chest tube site  20 minutes before removing chest tube.  pain intensity  evaluated by the visual analog scale three times:20 minutes before, just after and 15 minutes after chest tube removal. Intervention 2: control group:  100 mg Indomethacin suppository will be  administered one hour prior to Chest tube removal. In control  group same  cold pack with room tempreature (as placebo)  will be placed on chest tube site  20 minutes before removing chest tube.  pain intensity  evaluated by the visual analog scale three times:20 minutes before, just after and 15 minutes after chest tube removal.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link>Iran J Nurs Midwifery Res. 2014 Jan-Feb; 19(1): 77–81</results_url_link>
      <results_summary>Background:&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
Chest tube removal is a painful procedure. The goal of this study was to evaluate the effect of cold application in combination with Indomethacin suppository on chest tube removal pain in patients undergoing open heart surgery.&lt;br /&gt;&#13;
Materials and Methods:&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
This single-blind, double-group clinical trial was performed on 66 patients aged 18-68 years with the chest tube in pleural space. The Indomethacin suppository (100 mg) was administered 1 h before the chest tub removal in both groups. In the intervention group, we applied a 4°C cold pack in the chest tube side for 20 min. In the placebo group, the applied pack was at room temperature. Pain intensity was measured by Visual Analog Score 20 min before, immediately after, and 15 min after the chest tube removal.&lt;br /&gt;&#13;
Results:&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
Immediately after the CTR, the mean pain score was 2.67 ± 0.79 and 3.9 ± 0.76 in the intervention and placebo groups, respectively. The pain scores measured before and 15 min after the CTR were not statistically different between the two groups.&lt;br /&gt;&#13;
Conclusion:&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
Application of cold in combination with Indomethacin suppository during the CTR was a suitable, low-risk, and easy method for pain control in open heart patients.           </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>Mitra Payami Bousari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zanjan, Nursing and midwifery faculty of Zanjan University of Medical Sciences and Health Services, Parvin Eesami Ave.,\</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515786339</zip>
        <telephone>+98 24 1727 2057</telephone>
        <email>payami@zuma.ac.ir</email>
        <affiliation>Zanjan University of Medcial Sciences and Health Services</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mitra Payami Bousari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zanjan, Nursing and Midwifery faculty of Zanjan University of Medical Sciences and Health Services, Parvin Etesami Ave.</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515786339</zip>
        <telephone>+98 24 1727 2057</telephone>
        <email>payami@zums.ac.ir</email>
        <affiliation>Zanjan University of Medcial Sciences and Health Services</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria: patients undergo sternomy surgery,   range of age :18-69, oriented to time and place, able to answer to questions, not addicted to  drug , no smoking , Indometacin suppository or other kind of sedative have not being prescribed at least  6 hours before intervention also having no opoids prescription 12 hours before intervention, having at least one chest tube in pluera, having physician  order for  removing chest tube , &#13;
exclusion criteria: sudden change in patient status during the intervention, pain in other organs which affect chest tube removal pain such as heart pain</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>69 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I00-I99</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In Intervention  group 100 mg Indomethacin suppository will be  administered one hour before Chest tube removal. In intervention group a 4º c   cold pack will be placed on chest tube site  20 minutes before removing chest tube.  pain intensity  evaluated by the visual analog scale three times:20 minutes before, just after and 15 minutes after chest tube removal.&#13;
In controrl group:  100 mg Indomethacin suppository will be  administered one hour prior to Chest tube removal. In control  group same  cold pack with room tempreature (as placebo)  will be placed on chest tube site  20 minutes before removing chest tube.  pain intensity  evaluated by the visual analog scale three times:20 minutes before, just after and 15 minutes after chest tube removal.</i_keyword>
      <i_keyword>control group:  100 mg Indomethacin suppository will be  administered one hour prior to Chest tube removal. In control  group same  cold pack with room tempreature (as placebo)  will be placed on chest tube site  20 minutes before removing chest tube.  pain intensity  evaluated by the visual analog scale three times:20 minutes before, just after and 15 minutes after chest tube removal.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain of chest tube removal. Timepoint: 20 minutes before CTR , just after and 15 minutes after CTR. Method of measurement: visual analog scores (VAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Vital sign including Blood pressure, pulse, respiratory rate. Timepoint: 20 minutes before CTR, just after and 15 minutes after intervention. Method of measurement: mm/hg for BP, nomber for Pulse and respiratory rate announced by vital sign monitoring system Pooyandegan rahe Saadat made by iran.</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>Vice-chancellor for Research of Zanjan University of Medcial Sciences and Health Services</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-09-23</approval_date>
        <contact_name>Zanjan University of Medical Sciences &amp; health services</contact_name>
        <contact_address>Azadi Square,Zanjan University of Medical Sciences and Health Services Zanjan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-09-23</approval_date>
        <contact_name>Ethics comittee of Vice-chancellor for Research  of Zanjan university of medical sciences and health</contact_name>
        <contact_address>Azadi Square,Zanjan University of Medical Sciences and Health Services Zanjan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
