<?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>IRCT2015072223286N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-04-08</date_registration>
      <primary_sponsor>Vice Chancellor for Research Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of foot reflexology on fatigue, pain and physiological parameters in patients after coronary angiography</public_title>
      <acronym></acronym>
      <scientific_title>The effect of foot reflexology on fatigue, pain and physiological parameters in patients after coronary angiography</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>35</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19898</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Fatigue. Condition 2: Pain. Condition 3: Angiography.</hc_freetext>
      <i_freetext>Intervention 1: In reflexology group, massage is done by researcher and man collaborator( for male patients ) )for 10 minutes(5 minutes per foot). The sequence are used of relaxation and specific areas of the heart. Stages of relaxation include: Rhythmic ankle rotation( ankle rotation 4 time in the right and 4 times to the left to form the circle)and Wringing the foot( researcher thumbs are placed on the patient's abdominal area,then wringing the toe to the ankle,this work will be done 3 times) . After relaxation are used to stimulate the three areas of reflecting the solar plexus,heart,pituitary.the downward pressure are applied with the thumb in the heart,pituitary,solar plexus. then circular massage are applied the same points. With fatigue and pain VAS and physiologic parameters Questionnaire is recorded and assessed by collaborator , 2 hours after angiography, 2 and 4 hours after the procedure again. Intervention 2: In the control group intervention will not occur, except routine care and vital signs measurement.fatique ,pain and physiologic parameters Questionnaire recorded by collaborator and with presence of researcher at intervals corresponding reflexology group.</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>Ali Shokatiasl</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery، Tehran University of Medical Sciences، Nosrat St، Tohid Sq، Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1474948499</zip>
        <telephone>+98 21 4432 3872</telephone>
        <email>a-shokati@razi.tums.ac.ir; shokati16@yahoo.com</email>
        <affiliation>Faculty of Nursing and Midwifery، Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elham Navab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St، Tohid Sq، Tehran، Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4412</telephone>
        <email>e_navab100@hotmail.com; enavab@razi.tums.ac.ir</email>
        <affiliation>Faculty of Nursing and Midwifery، Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: willingness to participate in research ; non-emergency angiography ; The age range of eighteen to seventy-five years ; No disturbance of consciousness ; Lack of vascular injuries of the lower limbs and sensory-motor disorders of the feet (especially Diabetic Foot) ; The absence of abnormalities such as corns, burns, amputations and skin disorders in the legs ; lack of inter-vertebral disc herniation, low back pain and back pain Exclusion criteria: Failure to consent to continued participation ; Death participants ; hemodynamic instability (dysrhythmia, respiratory disorders, and severe changes in blood pressure requiring emergency interventions ; bleeding after angiography</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F48.8</hc_code>
      <hc_code>R52.0</hc_code>
      <hc_code>R93.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified neurotic disorders</hc_keyword>
      <hc_keyword>Acute pain</hc_keyword>
      <hc_keyword>Abnormal findings on diagnostic imaging of heart and coronary circulation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In reflexology group, massage is done by researcher and man collaborator( for male patients ) )for 10 minutes(5 minutes per foot). The sequence are used of relaxation and specific areas of the heart. Stages of relaxation include: Rhythmic ankle rotation( ankle rotation 4 time in the right and 4 times to the left to form the circle)and Wringing the foot( researcher thumbs are placed on the patient's abdominal area,then wringing the toe to the ankle,this work will be done 3 times) . After relaxation are used to stimulate the three areas of reflecting the solar plexus,heart,pituitary.the downward pressure are applied with the thumb in the heart,pituitary,solar plexus. then circular massage are applied the same points. With fatigue and pain VAS and physiologic parameters Questionnaire is recorded and assessed by collaborator , 2 hours after angiography, 2 and 4 hours after the procedure again.</i_keyword>
      <i_keyword>In the control group intervention will not occur, except routine care and vital signs measurement.fatique ,pain and physiologic parameters Questionnaire recorded by collaborator and with presence of researcher at intervals corresponding reflexology group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fatigue. Timepoint: Baseline and 2, 4 and 6 hours after intervention. Method of measurement: Visual Analoge Scale for Fatigue.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Baseline and 2, 4 and 6 hours after intervention. Method of measurement: Visual Analoge Scale for Pain.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: Baseline and 2, 4 and 6 hours after intervention. Method of measurement: Tytan Blood Pressure Devices.</prim_outcome>
      <prim_outcome>Pulse. Timepoint: Baseline and 2, 4 and 6 hours after intervention. Method of measurement: According to minutes using the standard clock.</prim_outcome>
      <prim_outcome>Breathing. Timepoint: Baseline and 2, 4 and 6 hours after intervention. Method of measurement: According to minutes using the standard clock.</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>Vice Chancellor for Research Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-12-15</approval_date>
        <contact_name>Faculty of Nursing and Midwifery , Tehran University of Medical Sciences</contact_name>
        <contact_address>Faculty of Nursing and Midwifery, Tehran University of Medical Sciences ، Nosrat St، Tohid Sq، Tehran, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
