<?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>IRCT20181113041644N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-12</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Assessing Effects of Educating Bowel Management Program On Quality Of Life In Children</public_title>
      <acronym></acronym>
      <scientific_title>Assessing Effects of Educating Bowel Management Program On Quality Of Life In Children With Fecal Incontinence at Mofid hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35204</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Randomization description: Children who come to a Mofid hospital clinic are selected by specialist confirmation and divided into two intervention and control groups according to their file number in the way that the odd numbers become the intervention group. We do not have blindness in this study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Fecal incontinence. Condition 2: Patients with fecal incontinence.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Children who are referred to us by a specialist  from the clinic and have an odd file number will be assessed by a pediatrician and nurse then the education program starts.  the education program will be as follows: The first session will be orientation. The student will communicate with them by introducing themselves and asking questions such as the name and surname of the children. The student will explain the purpose of the research and the method of intervention to be completely clear to children and their parents. After obtaining written consent from the children and their parents, complete examination of the patient by examining the pattern and frequency of excretion and consistency and form of the stool, the study of diet and fluid intake, behavioral examination and abnormal habits and examination of the abdomen and perinea in cooperation with the physician. The quality of life questionnaire will then be provided to  their parents during the same session to complete and deliver them during the same session or next meeting. At the next session on the second day, the curriculum will be performed on the basis of a survey conducted individually and within an hour, as well as a presentation of the pamphlet, and will be evaluated with questions from them and, if necessary, will be repeated again and will be available to all Questions for the child and parents will also be answered. In the next sessions that are on a daily basis, the child will first have a graph for the assessment of the bowel and, according to the physician's permission, the training program will continue or change, in which case the training will be carried out again by the nurse. . And by asking questions, the performance of the program is evaluated by him. Finally, on the seventh day, the final program of the gut management will be described and will be explained to the child and parents, and they will be asked to come back to the clinic one month later to re-examine and complete the quality of life questionnaire in the clinic. Tracking will be done by the student. During this time, the researcher's contact number will be provided to answer questions in the morning shift. Intervention 2: Control group: who receives even file number receives routine care and does not additional work for them anymore.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is I should consult with the professors</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shiva Hojjati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 217088655366</telephone>
        <email>shivahojjati@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shiva Hojjati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.56. madani6 . valfajr. tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 3314 1838</telephone>
        <email>shivahojjati@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>their willingness to participate in research
Between the ages of 4 and 16
A definitive diagnosis of incontinence by surgery
Be able to understand Persian language</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>16 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The caretakers are constantly changing
In a family, there is no other child with chronic illness.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R15</hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fecal incontinence</hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Children who are referred to us by a specialist  from the clinic and have an odd file number will be assessed by a pediatrician and nurse then the education program starts.  the education program will be as follows: The first session will be orientation. The student will communicate with them by introducing themselves and asking questions such as the name and surname of the children. The student will explain the purpose of the research and the method of intervention to be completely clear to children and their parents. After obtaining written consent from the children and their parents, complete examination of the patient by examining the pattern and frequency of excretion and consistency and form of the stool, the study of diet and fluid intake, behavioral examination and abnormal habits and examination of the abdomen and perinea in cooperation with the physician. The quality of life questionnaire will then be provided to  their parents during the same session to complete and deliver them during the same session or next meeting. At the next session on the second day, the curriculum will be performed on the basis of a survey conducted individually and within an hour, as well as a presentation of the pamphlet, and will be evaluated with questions from them and, if necessary, will be repeated again and will be available to all Questions for the child and parents will also be answered. In the next sessions that are on a daily basis, the child will first have a graph for the assessment of the bowel and, according to the physician's permission, the training program will continue or change, in which case the training will be carried out again by the nurse. . And by asking questions, the performance of the program is evaluated by him. Finally, on the seventh day, the final program of the gut management will be described and will be explained to the child and parents, and they will be asked to come back to the clinic one month later to re-examine and complete the quality of life questionnaire in the clinic. Tracking will be done by the student. During this time, the researcher's contact number will be provided to answer questions in the morning shift</i_keyword>
      <i_keyword>Control group: who receives even file number receives routine care and does not additional work for them anymore.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: Measurement of quality of life before intervention and one month after the end of intervention. Method of measurement: Using the quality of life questionnaire.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-11-15</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Valiasr street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
