<?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>IRCT20100105002992N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-02</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>The effect of reflexology (reflexology) on pain and anxiety and vital signs caused by chest tube removal</public_title>
      <acronym></acronym>
      <scientific_title>The effect of foot reflexology massage on pain, anxiety and physiological parameters during chest tube removal after open heart surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-10-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2912</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients with inclusion criteria, written in letters A ,B and C, were assigned into each test, placebo and control groups, respectively, through the lottery method.</study_design>
      <phase>N/A</phase>
      <hc_freetext>anxiety.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group (test): Before the chest tube removal, in the test group, the center of one third anterior left foot between the arch of the foot and the fingers (fin) of the patient's left leg  deeply and in a rotary manner (such as crushing a sugar cubes with a thumb ) massage was given for 10 minutes. Intervention 2: Second intervention group (placebo): In the placebo group, the third (heel) of the patient's left leg  deeply and in a rotary manner (such as crushing a sugar cubes with a thumb ) massage was given for 10 minutes. Intervention 3: Control group: In the control group there was no intervention and routine care was performed.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is currently no agreement with the research team on how to disseminate data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hossein Babatbar Darzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing, Baqiyatallah University of Medical Sciences, Molasadra Ave, District 3</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19575174</zip>
        <telephone>+98 21 2229 0205</telephone>
        <email>babatabar1343@yahoo.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeed Babajani Vafsi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing, Baqiyatallah University of Medical Sciences, Molasadra Ave, District 3</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19575174</zip>
        <telephone>+98 21 2229 0205</telephone>
        <email>babajanisaeed@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients hospitalized in heart surgery intensive care unit
Under the heart valves or coronary artery bypass graft surgeries
Having at least one chest tube
Candidate for chest tube removal (based on routine criteria in the admitted ward)
Male gender
Age ranges between 40 to 80 years
Having reading and writing literacy
Be wake up and consciousness (GCS = 15)
Numerical rate scores of pain greater than 4 (NRS&gt; 4)
Personality anxiety score greater than 33 (based on Spielberger questionnaire)</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>80 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>A history of chronic pain (such as rheumatoid arthritis, etc.)
A history of taking pain relief medications (analgesics, anti-inflammatory drugs and opioids)
A history of opium addiction
A  history of psychological disorders
A history of taking neurology and psychiatry medications
Taking opium medications until 4 hours ago
A history of sensory-motor disorders
A history of feet related problems and  abnormalities (such as Corns and calluses, burns, amputations, skin diseases, etc.)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group (test): Before the chest tube removal, in the test group, the center of one third anterior left foot between the arch of the foot and the fingers (fin) of the patient's left leg  deeply and in a rotary manner (such as crushing a sugar cubes with a thumb ) massage was given for 10 minutes.</i_keyword>
      <i_keyword>Second intervention group (placebo): In the placebo group, the third (heel) of the patient's left leg  deeply and in a rotary manner (such as crushing a sugar cubes with a thumb ) massage was given for 10 minutes.</i_keyword>
      <i_keyword>Control group: In the control group there was no intervention and routine care was performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before and immediately after intervention (every 5 minutes for 15 minutes). Method of measurement: Numeric Rating Scale (NRS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Physiological parameters (vital signs and oxygen saturation percent). Timepoint: Before intervention and after intervention every 5 minutes up to 15 minutes. Method of measurement: Vital signs monitoring.</sec_outcome>
      <sec_outcome>Anxiety. Timepoint: Before (state and trait anxiety) and immediately after intervention (state anxiety). Method of measurement: Spielberger's The State-Trait Anxiety Inventory (STAI)- 40 question form.</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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-05-18</approval_date>
        <contact_name>Ethics committee of  Baqiatallah University of Medical Sciences</contact_name>
        <contact_address>Molasadra Ave. Baqiyatallah University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
