<?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>IRCT201301196284N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-05-18</date_registration>
      <primary_sponsor>Vice chancellor for research of Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of foot massage on anxiety before and after hysterectomy</public_title>
      <acronym></acronym>
      <scientific_title>The Impact of  foot  massage on anxiety before and after hysterectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-01-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6733</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>3</phase>
      <hc_freetext>Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: In  control group patients during the massage in intervention group, attended the bedside for 20 minutes and create rapport addition, Berger anxiety questionnaire before and 30 minutes after the intervention is completed. One week after surgery for following again berger state questionaire with patient by the researcher calling is completed. Intervention 2: In patient intervention group foot special massage done. In this massage base of the palm,the palm and fingers to movement rubbing, rotation, pull, grasping, push and flexing in different part ( both sides of foots, the narrow  foot, toe,  heel, edge toe, fingers, between fingers, the dorsal surface of the foot, the inner edge of edge of the foot, the up surface of the foot) used. The general movement of the ankle and toes done . The massage is a 3 step, 20 movement in each specialized massage movement are carried out on the patient legs. This massage during 20 minutes done (each foot 10 minutes). This intervention one day before surgery and first, second postoperative day is performed on patients once a day in the intervention 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>Maryam Modarres</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>faculty of nursing and midwifery, beginning of the Nosrat street,Tohid square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>ma_modars@yahoo.com</email>
        <affiliation>Nursing-Midwifery university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Modarres</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>faculty of nursing and midwifery, beginning of the Nosrat street,Tohid square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>ma_modars@yahoo.com</email>
        <affiliation>Nursing-Midwifery university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
 At least literate; not having the surgery With the exception of  oophorectomy; hysterectomy  to benign compliant until time study; No having history of foot massage; After gaining consciousness; At least one day before surgery and 2 days after surgery in the hospital; For long term (more than one month, tranquilizers, pain or anxiety drugs such as inderal is not received; Lack of drug addiction; No known diseases as diabetes, heart disease, mental disorders, movement disorders, impaired vision, hearing; having a healthy part of legs.&#13;
&#13;
Exclusion criteria:&#13;
 Severe complications after surgery such as bleeding, infection, need for care in the intensive care unit; Lack of access to experimental conditions during the study (for example discomfort and ...); Lack of patient consent to continue participation in the study.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>85 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>f40-f41-f4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Neurotic, stress-related and somatoform disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In  control group patients during the massage in intervention group, attended the bedside for 20 minutes and create rapport addition, Berger anxiety questionnaire before and 30 minutes after the intervention is completed. One week after surgery for following again berger state questionaire with patient by the researcher calling is completed.</i_keyword>
      <i_keyword>In patient intervention group foot special massage done. In this massage base of the palm,the palm and fingers to movement rubbing, rotation, pull, grasping, push and flexing in different part ( both sides of foots, the narrow  foot, toe,  heel, edge toe, fingers, between fingers, the dorsal surface of the foot, the inner edge of edge of the foot, the up surface of the foot) used. The general movement of the ankle and toes done . The massage is a 3 step, 20 movement in each specialized massage movement are carried out on the patient legs. This massage during 20 minutes done (each foot 10 minutes). This intervention one day before surgery and first, second postoperative day is performed on patients once a day in the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Before and 30 minutes after the first intervention, before and 30 minutes after the second intervention, before and 30 minutes after the third intervention, one week after hysterectomy. Method of measurement: Anxiety by STAI anxiety questionnaire measures .</prim_outcome>
      <prim_outcome>Vital sign. Timepoint: Before and 30 minutes after the first intervention, before and 30 minutes after the second intervention, before and 30 minutes after the third intervention. Method of measurement: vital signs, including blood pressure through mercury sphygmomanometer in millimeters of mercury and pulse through touch radial arterial of hand for 1 minute and respiratory through movement chest for 1 minute.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Age patient. Timepoint: Before first  intervention. Method of measurement: Demographic information questionaire.</sec_outcome>
      <sec_outcome>Patient job. Timepoint: Before first intervention. Method of measurement: Demographic information questionaire.</sec_outcome>
      <sec_outcome>Patient husband job. Timepoint: Before first intervention. Method of measurement: Demographic information questionaire.</sec_outcome>
      <sec_outcome>Income. Timepoint: Before first intervention. Method of measurement: Demographic information questionaire.</sec_outcome>
      <sec_outcome>Patient education. Timepoint: Before first intervention. Method of measurement: Demographic information questionaire.</sec_outcome>
      <sec_outcome>Patient husband education. Timepoint: Before first intervention. Method of measurement: Demographic information questionaire.</sec_outcome>
      <sec_outcome>Marital status. Timepoint: Before first intervention. Method of measurement: Demographic information questionaire.</sec_outcome>
      <sec_outcome>Number of children. Timepoint: Before first intervention. Method of measurement: Demographic information questionaire.</sec_outcome>
      <sec_outcome>Menopause status. Timepoint: Before first intervention. Method of measurement: Demographic information questionaire.</sec_outcome>
      <sec_outcome>Anesthesia method. Timepoint: Before second intervention. Method of measurement: Operation questionaire.</sec_outcome>
      <sec_outcome>Surgery method. Timepoint: Before second intervention. Method of measurement: Operation questionaire.</sec_outcome>
      <sec_outcome>Hysterectomy reason. Timepoint: Before first intervention. Method of measurement: Demographic information questionaire.</sec_outcome>
      <sec_outcome>Duration of disease diagnosis. Timepoint: Before first  intervention. Method of measurement: Demographic information questionaire.</sec_outcome>
      <sec_outcome>Surgery history. Timepoint: Before first intervention. Method of measurement: Demographic information questionaire.</sec_outcome>
      <sec_outcome>Hospitalization. Timepoint: Before first intervention. Method of measurement: Demographic information questionaire.</sec_outcome>
      <sec_outcome>The amount of medication to reduce pain. Timepoint: First and second day after surgery. Method of measurement: Recorded in milligrams per questionnaire Surgery.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>no</sec_id>
        <issuing_authority>no</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice chancellor for research of Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-07-11</approval_date>
        <contact_name>Ethics Committee Tehran university of Medical sciences</contact_name>
        <contact_address>sixth floor,centeral organization of university, edge of Qods street, keshavarz blvd, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
