<?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>IRCT201401046778N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-04-24</date_registration>
      <primary_sponsor>School of Nursing - University of Medical Sciences ... (Aj)</primary_sponsor>
      <public_title>The Effect of Foot Reflexotherapy on Physiological Indexes and Weaning Time</public_title>
      <acronym></acronym>
      <scientific_title>The effect of foot reflexotherapy on physiological Indexes and weaning time after open heart surgery in Baqiyattallah university of medical sciences hospitals</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-02-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7189</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>cardiac surgery.</hc_freetext>
      <i_freetext>Intervention 1: intervention groups ,  Foot reflexology in this case,The first step should be holding foot for a minute. Secondly, for each foot perform foot spread for a minute. In the third stage, the four fingers of both hands on the dorsal surface of the foot (the left foot, then right foot) has been given the thumbs on the hands (the Ball every foot reflexology areas of the heart and lungs are in this area) rotating basis  7-10 minutes and with gentle pressure massage will. And the final step will take a minute Top sliding. Overall, both legs will massage for 20 minutes. Intervention 2: Placebo treatment group after the first hour, the soles of both feet will touch the surface. A total duration of 20 minutes for both legs (each leg separately, 10 minutes) will be. Intervention 3: The control group received no intervention and usual care patients will be monitored.</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>Seyed Tayeb Moradian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Sadra St., St. Sheikh Bahai University of Medical Sciences ... (Aj)</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>00</telephone>
        <email>t-moradian@razi.tums.ac.ir</email>
        <affiliation>Nursing Faculty, Baghiyyatallah university of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Abbas Ebbadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baghiyatallah University of medical sciences, Sheykh Bahaei street, Tehra</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2228 6057</telephone>
        <email>ebadi1347@yahoo.com</email>
        <affiliation>Nursing faculty, Baghiyatallah University of medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: patients with non-emergency cardiac surgery; age greater than 18 and less than 75 years; has a heart rate greater than 60 beats per minute; systolic blood pressure greater than 90 mm Hg; healthy legs&#13;
Exclusion criteria were: hemodynamic instability; delayed weaning process based on the physician's order; return to the operating room; dependance to the intra aortic balloon pump</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>j95.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute pulmonary insufficiency following thoracic surgery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention groups ,  Foot reflexology in this case,The first step should be holding foot for a minute. Secondly, for each foot perform foot spread for a minute. In the third stage, the four fingers of both hands on the dorsal surface of the foot (the left foot, then right foot) has been given the thumbs on the hands (the Ball every foot reflexology areas of the heart and lungs are in this area) rotating basis  7-10 minutes and with gentle pressure massage will. And the final step will take a minute Top sliding. Overall, both legs will massage for 20 minutes.</i_keyword>
      <i_keyword>Placebo treatment group after the first hour, the soles of both feet will touch the surface. A total duration of 20 minutes for both legs (each leg separately, 10 minutes) will be.</i_keyword>
      <i_keyword>The control group received no intervention and usual care patients will be monitored.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weaning Time. Timepoint: Since entering until extubation. Method of measurement: Using the Clock.</prim_outcome>
      <prim_outcome>Physiological Indexes. Timepoint: Log since the first time at the reception immediately following the intervention, ten minutes after the intervention, during extubation, and an hour later. Method of measurement: Using Patient Monitoring.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Reduce anxiety. Timepoint: Since  entrance patient, the first hour, immediately and 10 minutes after massage and extubation and one hour after extubation. Method of measurement: FAS criteria.</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>School of Nursing - University of Medical Sciences ... (Aj)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-01-05</approval_date>
        <contact_name>Baqiyatallah University of Medical Science</contact_name>
        <contact_address>Molla Sadra Ave, Vanak Square, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
