<?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>IRCT2016053128200N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-07-04</date_registration>
      <primary_sponsor>Vice Chancellor for research of Tehran University of Social Welfare and Rehabilitation Sciences</primary_sponsor>
      <public_title>The effect of foot reflexology massage on pain and anxiety</public_title>
      <acronym>-</acronym>
      <scientific_title>The effect of foot reflexology massage on pain and anxiety of male patients after abdominal surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22929</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Simple random.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: pain. Condition 2: anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: to relieve the pain of experimental group, foot reflexology massage is used and narcotic drugs as well if necessary. The intervention of experimental group includes foot reflexology massage which is done by the researcher after training and receiving the certification of reflexology performance from massage Art Institute of Iran. Foot reflexology massage is done without using cream or conditioner for 30 minutes (15 minutes per foot) in certain areas of abdominal surgery on foot. Then immediately after intervention, ten minutes later, and 24 hours later the intervention, the severity of pain and anxiety is measured. Intervention 2: Control group: for control group, analgesic drugs in necessary situations and usual care are done. There is no intervention in control group, but just in time parallel with the experimental group, its severity of pain and anxiety is measured. Intervention 3: Placebo group: for the placebo group, a simple massage on the foot is done and analgesic drugs as well if necessary. The severity of pain and anxiety of patients is measured immediately before the intervention. Then a 30 minute massage movements not the real massage runs in the sole of the patient's foot. These pressures are not on the surgical parts of the patient, then immediately, ten minutes and 24 hours after the end of the massage, the intensity of pain and anxiety is measured.</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>Abolfazl Rahimi Zarchi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kodakyar Avenue, Daneshjo Blvd., Evin, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713834</zip>
        <telephone>+98 21 2218 0085</telephone>
        <email>amozesh@uswr.ac.ir</email>
        <affiliation>Tehran University of Social Welfare and Rehabilitation Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Doctor Mohammad Ali Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>kodakyar Ave., daneshjo Blvd.,Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713834</zip>
        <telephone>+98 21 2218 0085</telephone>
        <email>amozesh@uswr.ac.ir</email>
        <affiliation>University of Social Welfare and Rehabilitation Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: admitted for abdominal surgery; Age between 15 to 60 years old; lack of analgesics before intervention having; healthy feet, especially the soles of them; getting the minimum score of pain intensity from three and more base on the visual analogue scale; full consciousness after surgery; Lack of addiction to drugs, alcohol and...; Lack of sensory and motor derangement according to the doctor's opinion or the existent information in the document or the patient saying itself; Lack of fever and skin diseases according to the doctor's opinion or the existent information in the document or the patient saying itself; Lack of hearing disorders according to the doctor's opinion or the existent information in the document or the patient saying itself; Lack of any physical and mental disorder except recent surgery according to the doctor's opinion or the existent information in the document or the patient saying itself; Lack of the experience of using  foot reflexology massage; Lack of Chronic pain in other parts of the body (migraine, low back pain and ...) according to the doctor's opinion or the existent information in the document or the patient saying itself; Exclusion criteria: addiction diagnostic to drugs, alcohol, etc. After the inclusion; spinal anesthesia; lack of desire to continue cooperation in the study; tenderness or massage; any intervention process because the person is unable to tolerate or pursue</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>60 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R10.0</hc_code>
      <hc_code>F41.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute abdomen</hc_keyword>
      <hc_keyword>Generalized anxiety disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Placebo</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: to relieve the pain of experimental group, foot reflexology massage is used and narcotic drugs as well if necessary. The intervention of experimental group includes foot reflexology massage which is done by the researcher after training and receiving the certification of reflexology performance from massage Art Institute of Iran. Foot reflexology massage is done without using cream or conditioner for 30 minutes (15 minutes per foot) in certain areas of abdominal surgery on foot. Then immediately after intervention, ten minutes later, and 24 hours later the intervention, the severity of pain and anxiety is measured.</i_keyword>
      <i_keyword>Control group: for control group, analgesic drugs in necessary situations and usual care are done. There is no intervention in control group, but just in time parallel with the experimental group, its severity of pain and anxiety is measured.</i_keyword>
      <i_keyword>Placebo group: for the placebo group, a simple massage on the foot is done and analgesic drugs as well if necessary. The severity of pain and anxiety of patients is measured immediately before the intervention. Then a 30 minute massage movements not the real massage runs in the sole of the patient's foot. These pressures are not on the surgical parts of the patient, then immediately, ten minutes and 24 hours after the end of the massage, the intensity of pain and anxiety is measured.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: immediately before intervention- immediately after invention- 10 minutes after intervention- 24 hours after intervention. Method of measurement: visual analog scale.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: immediately before intervention- immediately after invention- 10 minutes after intervention- 24 hours after intervention. Method of measurement: Spielberger anxiety inventory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>-. Timepoint: -. Method of measurement: -.</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 of Tehran University of Social Welfare and Rehabilitation Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-05-24</approval_date>
        <contact_name>Ethics committee of Tehran University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>Kodakyar Avenue, Daneshjo Blvd., Evin, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
