<?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>IRCT2014102711538N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-01-08</date_registration>
      <primary_sponsor>guilan university of medical sciences</primary_sponsor>
      <public_title>The Effect of foot reflexology on anxiety and physiological parameters</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of foot reflexology on anxiety and physiological parameters of patients undergoing coronary angiography</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>162</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11759</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>anxiety ,physiological parameters.</hc_freetext>
      <i_freetext>Intervention 1: In reflexology group, massage is done by  researcher and man collaborator( for male patients ) )for 20 minutes(10 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. Anxiety and physiologic parameters Questionnaire is recorded and assessed by collaborator ,Immediately and  half an hour after the procedure again. Intervention 2: In the control group intervention will not occur, except routine care and vital signs measurement . Anxiety 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>maria khorsand fard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>nursing of midwifery faculity,daneshjoo street,shahid beheshti ring way,rasht</address>
        <city>rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41941-68648</zip>
        <telephone>+98 13 3372 9257</telephone>
        <email>merinderella@yahoo.com</email>
        <affiliation>guilan university of medical science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>farideh hasavari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>nursing of midwifery faculity,daneshjoo street,shahid beheshti ring way,rasht</address>
        <city>rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41469-68648</zip>
        <telephone>+98 13 3355 5056</telephone>
        <email>fHasavari@gums.ac.ir   f.hasavari@gmail.com</email>
        <affiliation>guilan university of medical science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:  Age of 18 -75 years; Full awareness and ability to communicate;  Without history of coronary angiography and Using reflexology; Absence of relaxation and  Psychotherapy episodes; Absence of effective psychiatric medication according of the patient statements and material in file; Heart rate above the 60 beats per minute ; systolic blood pressure above the 90 mm Hg; Temperature of 36.5 ° -37.5 ° C; Not  arrhythmia ; Absence of addiction to drugs and alcohol according to file; Absence employment in medical treatment;  Absence of fractures; wounds and skin problems in the areas of massage.&#13;
 exclusion criteria: Patient's dissatisfaction to participate in research;Cardiopulmonary resuscitation ; Cancellation angiography during the study;Creates Chest pain and dyspnoea</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>f50-f59,R0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Symptoms and signs involving the circulatory and respiratory systems,Behavioural syndromes associated with physiological disturbances and physical factors</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 reflexology group, massage is done by  researcher and man collaborator( for male patients ) )for 20 minutes(10 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. Anxiety and physiologic parameters Questionnaire is recorded and assessed by collaborator ,Immediately and  half an hour after the procedure again.</i_keyword>
      <i_keyword>In the control group intervention will not occur, except routine care and vital signs measurement . Anxiety 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>Anxiety and- physiological parameters. Timepoint: 10 minutes before of the intervention-Immediately -half an hour after the procedure. Method of measurement: Hospital Anxiety Questionnaire-Measure blood pressure in millimeters of o mercury by using mercury manometers-Temperature in degrees Celsius by using mercury thermometer-Pulse and respiratory rate counting is based on the number of minutes in one minute using an analog clock complete.</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>guilan university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-11-25</approval_date>
        <contact_name>guilan university of medical science</contact_name>
        <contact_address>Namjoo Street, Guilan University of Medical Science rasht  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
