<?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>IRCT2016030617876N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-04-07</date_registration>
      <primary_sponsor>Vice-Chancellor for Research of Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effects of interferential electrical stimulation and pelvic floor muscle exercises on functional constipation in children</public_title>
      <acronym></acronym>
      <scientific_title>Effects of interferential electrical stimulation and functional pelvic floor muscle exercises on functional constipation and painful defecation in children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-05-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16348</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>1</phase>
      <hc_freetext>Constipation.</hc_freetext>
      <i_freetext>Intervention 1: Children in case group underwent 10 therapeutic  sessions  , 2 times per week.In each session, patients underwent functional pelvic floor muscle exercises, toilet training and IF electrical stimulation. IF therapy was applied for 20 minutes, frequency  of 5–25 Hz for a duration of 250 μs, and a repeat time of 6 s with adjustable amplitude (0–50 mA). .Two rectangular (2.5×3.5 cm) electrodes, one from each channel, were placed on the skin of anterior abdominal wall bellow the costal margin bilaterally and two other electrodes from each channel were crossly placed on the back between T12 and L4 on either sides of the patients.The current from each channel crossed inside the abdomen. The intensity was increased until the patient declared a strong but comfortable level of sensory awareness with no muscle contractions. Maximum current intensity was below the pain threshold and was tolerated well by the patients. Intervention 2: Children in control group underwent 10 therapeutic sessions , 2 times per week.In each session, patients underwent functional pelvic floor muscle exercises, toilet training and sham IF electrical stimulation. Sham IF therapy was applied for 20 minutes .Two rectangular (2.5×3.5 cm) electrodes, one from each channel, were placed on the skin of anterior abdominal wall bellow the costal margin bilaterally and two other electrodes from each channel were crossly placed on the back between T12 and L4 on either sides of the patients. The intensity was not  increased.</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>Lida Sharifi Rad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Children's Hospital Medical Center, No. 62,  Dr. Qarib’s St, Keshavarz Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6147 2090</telephone>
        <email>l-sharifirad@farabi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hossein Alimadadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Children's Hospital Medical Center, No. 62,  Dr. Qarib’s St, Keshavarz Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6147 2090</telephone>
        <email>Hoseinalimadadi@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:  Age more than 4 years old; abnormal stool form; painful defecation; defecation frequency less than 3 times per week&#13;
Exclusion criteria: Neuropathic bowel dysfunction; inflammatory disease; metabolic disease</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K59.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>constipation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Children in case group underwent 10 therapeutic  sessions  , 2 times per week.In each session, patients underwent functional pelvic floor muscle exercises, toilet training and IF electrical stimulation. IF therapy was applied for 20 minutes, frequency  of 5–25 Hz for a duration of 250 μs, and a repeat time of 6 s with adjustable amplitude (0–50 mA). .Two rectangular (2.5×3.5 cm) electrodes, one from each channel, were placed on the skin of anterior abdominal wall bellow the costal margin bilaterally and two other electrodes from each channel were crossly placed on the back between T12 and L4 on either sides of the patients.The current from each channel crossed inside the abdomen. The intensity was increased until the patient declared a strong but comfortable level of sensory awareness with no muscle contractions. Maximum current intensity was below the pain threshold and was tolerated well by the patients.</i_keyword>
      <i_keyword>Children in control group underwent 10 therapeutic sessions , 2 times per week.In each session, patients underwent functional pelvic floor muscle exercises, toilet training and sham IF electrical stimulation. Sham IF therapy was applied for 20 minutes .Two rectangular (2.5×3.5 cm) electrodes, one from each channel, were placed on the skin of anterior abdominal wall bellow the costal margin bilaterally and two other electrodes from each channel were crossly placed on the back between T12 and L4 on either sides of the patients. The intensity was not  increased.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Defecation frequency per week. Timepoint: At the end of treatment sessions and 6 months later. Method of measurement: Filling out bowel habit diary by parents.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fecal soiling episods. Timepoint: At the end of treatment sessions and 6 months later. Method of measurement: Bowel habit diary.</sec_outcome>
      <sec_outcome>Stool form. Timepoint: At the end of treatment sessions and 6 months later. Method of measurement: Bristol Stool Form.</sec_outcome>
      <sec_outcome>Pain. Timepoint: At the end of treatment sessions and 6 months later. Method of measurement: A visual pain score.</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 Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-11-27</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Qhods St, Keshavarz Bolv. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
