<?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>IRCT2015061322682N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-11-07</date_registration>
      <primary_sponsor>Vic Chancellor for research of Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of transcutaneous electrical nerve stimulation in acupuncture points with the incision site</public_title>
      <acronym>-</acronym>
      <scientific_title>Comparison of transcutaneous electrical nerve stimulation in acupuncture points with the incision site on post operative complications and physiological indicators after appendectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19512</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients will divided accidentally to 4 groups (Table of random numbers).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Appendicitis.</hc_freetext>
      <i_freetext>Intervention 1: 15 minute after discharging of recovery in first group, in addition to routine cure in part, patients are cured under transcutaneous electrical nerve stimulation in acupuncture point (LI4, ST36, PC6) put in form of two sided with frequency 100 HZ and circuiting within tolerance for 20 minutes. Intervention 2: 15 minutes after discharging of recovery in second group, in addition to routine cures in part, patients are cured under transcutaneous electrical nerve stimulation in places of incision (4 cm far from cutting place in form two sided) with frequency 100 HZ and circuitry within tolerance for 20 minute. Intervention 3: 15 minute after discharging of recovery, in third group in addition to routine cures in part, patients are cured under transcutaneous electrical nerve stimulation in acupuncture points and incision site (instruments pads are putting in related points but TENS device does not tern) for 20 minute. Intervention 4: 15 minute after discharging of recovery in fourth group, just routine cures are done and there is no intervention by researcher.</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>Dr Mousa Sajjadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gonabad University of Medical Sciences, Gonabad, Khorasan Razavi, Iran</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9691793718</zip>
        <telephone>+98 51 5722 3513</telephone>
        <email>Sajjadi1975@gmail.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahsa Moazzen Ahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sajadie Hospital, Fariman special road, Torbat Jam, Khorasan Razavi, Iran</address>
        <city>Torbat Jam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9576175544</zip>
        <telephone>+98 51 5252 9312</telephone>
        <email>Moazzenm2@mums.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: men and women 14-45 years old; under appendectomy. Exclusion criteria; history of skin disease; history of cardiac disease; cognitive disease; diabetes disease; addiction; history of using TENS or acupuncture and pregnancy.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k35-2,k35-</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Appendicitis (acute) with generalized (diffuse) peritonitis following rupture or perforation,    Acute appendicitis with localized peritonitis with or without rupture or perforation     Acute appendicitis with peritoneal absces,Acute appendicitis without </hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>15 minute after discharging of recovery in first group, in addition to routine cure in part, patients are cured under transcutaneous electrical nerve stimulation in acupuncture point (LI4, ST36, PC6) put in form of two sided with frequency 100 HZ and circuiting within tolerance for 20 minutes.</i_keyword>
      <i_keyword>15 minutes after discharging of recovery in second group, in addition to routine cures in part, patients are cured under transcutaneous electrical nerve stimulation in places of incision (4 cm far from cutting place in form two sided) with frequency 100 HZ and circuitry within tolerance for 20 minute.</i_keyword>
      <i_keyword>15 minute after discharging of recovery, in third group in addition to routine cures in part, patients are cured under transcutaneous electrical nerve stimulation in acupuncture points and incision site (instruments pads are putting in related points but TENS device does not tern) for 20 minute.</i_keyword>
      <i_keyword>15 minute after discharging of recovery in fourth group, just routine cures are done and there is no intervention by researcher.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: before intervention, immediately after intervention, 10 minute after and at the end of 20 minute intervention. Method of measurement: Visual Analogue Scale of pain.</prim_outcome>
      <prim_outcome>Nausea. Timepoint: before intervention, immediately after intervention, 10 minute after and at the end of 20 minute intervention. Method of measurement: Visual Analogue Scale of nausea.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Amount of pain relief. Timepoint: before intervention, immediately after intervention, 10 minute after and at the end of 20 minute intervention. Method of measurement: cc.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: before intervention,immediately after intervention,10 minute after and at the end of 20 minute intervention. Method of measurement: pressure indicator.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: before intervention, immediately after intervention, 10 minute after and at the end of 20 minute intervention. Method of measurement: Probe monitor.</sec_outcome>
      <sec_outcome>Respiratory rate. Timepoint: before intervention, immediately after intervention, 10 minute after and at the end of 20 minute intervention. Method of measurement: see chest.</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>Vic Chancellor for research of Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-03-11</approval_date>
        <contact_name>Ethics committe of Gonabad University of Medical Sciences</contact_name>
        <contact_address>Gonabad University of Medical Sciences, Gonabad, Khorasan Razavi, Iran Gonabad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
