<?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>IRCT201103195665N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-07-20</date_registration>
      <primary_sponsor>Tabriz Medical Science University, Vice chancellor for research, Dr. Mohamreza Rashidi</primary_sponsor>
      <public_title>Impact of patient - controlled analgesia on patient's satisfaction  after cardiac surgery in Shahid Rajaei Heart center in 2011.</public_title>
      <acronym></acronym>
      <scientific_title>Impact of patient - controlled analgesia on patient's satisfaction  after coronary artery bypass surgery in Shahid Rajaei Heart center in 2011.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-08-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size></target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6178</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research.</study_design>
      <phase>3</phase>
      <hc_freetext>pain control after heart surgery.</hc_freetext>
      <i_freetext>Intervention 1: The interventional group, to be trained using Patient Control Analgesia (PCA=Patient Control Analgesia pump).In this method during two days post surgery, the physician determines the type and parameters of analgesia doses and the patient receives the base doses of analgesia by intravenous infusion, and he just have control on injection pump and when he needs to analgesia, pushes the PCA pump so the set adjusted based on physician order and patient demand, so he  cannot receive more than ordered parameters ). So he can take analgesia before worsen his pain and when he needs more doses of analgesia. Intervention 2: In control group the pain will control by the nurse (Nurse Control Analgesia) as usual and routine of unit, based on physician orders, during two days postoperatively. &#13;
During two days the satisfaction of patients in two groups with the pain control will be completed by a blinded nurse, and she will fill in the Pain Control Satisfaction Questionnaire. &#13;
At the end, the satisfaction with the pain control in two groups and pain severity scale will compare statistically by SPSS.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link>http://journals.tbzmed.ac.ir/JCS/Archive/1/4</results_url_link>
      <results_summary>         Introduction: Pain has been pointed out as one of the concerns of cardiac surgery patients. Studies have shown that nurses often underestimate patient's pain and patients generally receive inadequate analgesia. Acute pain management has been a challenge for health professionals and several regiments have been described. We designed this study to evaluate the effectiveness of pain control with IV patient-controlled analgesia (PCA) versus conventional nurse-controlled analgesia (NCA) after coronary artery bypass graft (CABG) surgery on patient's satisfaction during the postoperative period in the intensive care unit (ICU).&lt;br /&gt;&#13;
Methods: In this randomized clinical trail, 80 patients undergone first-time elective CABG enrolled by convenience sampling and were randomly allocated in two groups. PCA with continuous morphine infusion was started immediately after transferring to the ICU. NCA was based on intravenous injections of morphine on demand (PRN). Pain assessment (with verbal rating scale [VRS]), sedation level, morphine consumption and side effects were evaluated from extubation until 48 hours after surgery also patient's satisfaction and nurses opinion of PCA method were obtained. Data were analyzed using SPSS 17.&lt;br /&gt;&#13;
Results: VRS scores were higher in the NCA group 3.27±1.17 compared with 0.75±0.66 in the PCA group (p </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>Atoosa Hosseinzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5138947977, Nursing and Midwifery Faculty, Shariati Jnoobi Ave, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 1477 0648</telephone>
        <email>Atoosa.Hosseinzaeh@yahoo.com</email>
        <affiliation>Tabriz Medical Science University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sima Lakdizaji</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5138947977, Tabriz Nursing and Midwifery Faculty,  Shariati Jnoobi Ave.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 1477 0648</telephone>
        <email>laks@tbzmed.ac.ir; lak1369@yahoo.com</email>
        <affiliation>Vice chancellor for research, Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age 30-60 years old; admission in cardiac surgery ICU for bypass surgery; consent for participation in research&#13;
Exclusion criteria: to have addiction; sensitivity for Morphine; not to be able for working with patient control anesthesia; renal diseases with creatine more than2; liver disease; to have re surgery for bleeding; psychological disease; unstable hemodynamic status with blood presser less than 90 mmHg, and receiving  inotrope  medications; low consciousness; ejection fraction less than %30;entrance to operating room by emergency; intubation more than 6 hours.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>197.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other post procedural disorders of circulatory system, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The interventional group, to be trained using Patient Control Analgesia (PCA=Patient Control Analgesia pump).In this method during two days post surgery, the physician determines the type and parameters of analgesia doses and the patient receives the base doses of analgesia by intravenous infusion, and he just have control on injection pump and when he needs to analgesia, pushes the PCA pump so the set adjusted based on physician order and patient demand, so he  cannot receive more than ordered parameters ). So he can take analgesia before worsen his pain and when he needs more doses of analgesia.</i_keyword>
      <i_keyword>In control group the pain will control by the nurse (Nurse Control Analgesia) as usual and routine of unit, based on physician orders, during two days postoperatively. &#13;
During two days the satisfaction of patients in two groups with the pain control will be completed by a blinded nurse, and she will fill in the Pain Control Satisfaction Questionnaire. &#13;
At the end, the satisfaction with the pain control in two groups and pain severity scale will compare statistically by SPSS.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Patient satisfaction of pain control. Timepoint: every 12 hours after heart surgery until 2 days after surgery. Method of measurement: Pain Treatment Satisfaction Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Nurses opinions about pain control method. Timepoint: every 12 hours after heart surgery until 2 days postsurgery. Method of measurement: by 6 questions about nurses opinions.</sec_outcome>
      <sec_outcome>Pain Severity. Timepoint: Every 4 hours for 2 days after surgery. Method of measurement: Visual Analog Scale.</sec_outcome>
      <sec_outcome>Sedation level. Timepoint: Every 4 hours for 2 days after surgery. Method of measurement: Sedation Scale.</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>Tabriz Medical Science University, Vice chancellor for research, Dr. Mohamreza Rashidi</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-04-25</approval_date>
        <contact_name>Tabriz Medical Science University, Vice chancellor for research, Ethics committee</contact_name>
        <contact_address>Vice chancellor for research, Amoozesh Building, Tabriz Medical Science University, Daneshgah Ave, Tabriz Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
