<?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>IRCT20160802029166N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-04-19</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences and Health Services</primary_sponsor>
      <public_title>The Effectiveness of self-care skills training on self-esteem and quality of life in children with stoma</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Self-Care Skills Training on Self-Esteem and Quality of Life in 8-12 Year Old Children with Stoma of Hospitals in Tehran in 1395</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23516</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sample file number was written on small paper and was packed in a packet and 18 case files were randomly selected as case group and 18 were randomly assigned to the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Hirschsprung disease. Condition 2: Other congenital functional disorders of colon. Condition 3: Other congenital malformations of bladder and urethra.</hc_freetext>
      <i_freetext>Intervention 1: Intervention as self-care skills training sessions including referral, familiarity with osteoporosis, exchange of colostomy bag, diet in osteoporosis patients, exercise and daily activity, and practical evaluation of interventional group for replacing osteoarthritis in 6 training sessions of 45 minutes prior to Surgery was conducted with pamphlets and educational videos. Intervention 2: Control group: The control group consisted of 18 children with ostoma (8-12 years old) admitted to selected hospitals in Tehran who did not receive any training on self care skills. Intervention 3: Intervention group: The intervention group consisted of 18 children with ostoma (8-12 years old) admitted to selected hospitals in Tehran who were trained in self-care skills in 6 sessions of 45 minutes (familiarity with ostoma, how to exchange colostomy bag, diet in ostomates, exercise and Daily activities).</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 Most of the participants in the study, even with the confidentiality of information and the unidentifiability of individual data, did not tend to publish their data elsewhere. The researcher was forced to accept this request because of the limited sample of the study and the research was carried out</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nazanin Shahedi Joghan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Rey city, Dolat Abad First Colloq, Ahmad Ali Nawaz St, Hasan Hassanzadeh Plain No. 13</address>
        <city>Rey</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>18578-87137</zip>
        <telephone>+213 3756046</telephone>
        <email>shahedi2011@yahoo.com</email>
        <affiliation>Self-governing pardis of Shahid Beheshti University of Medical Sciences and Health Services</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Jamile Mohtashami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran - Vale Asr Ave. - Intersection of Prayer - In front of Shahid Rajaee Heart Hospital - Faculty of Nursing and Midwifery</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+218 865536671</telephone>
        <email>jmohtashami@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences and Health Services</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children under the age of 12 and over 8 years old
Samples have not recently participated in ostoma self-care training courses
Parents said that they have no illness, physical disability, mental retardation or other behavioral disorder
Conscious informed consent to participate in the study</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Children who had absent more than two sessions
Individuals who participated in self-care sessions at the same time in the field of stoma.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Q43.1</hc_code>
      <hc_code>Q43.2</hc_code>
      <hc_code>Q64.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hirschsprung's disease</hc_keyword>
      <hc_keyword>Other congenital functional disorders of colon</hc_keyword>
      <hc_keyword>Other congenital malformations of bladder and urethra</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention as self-care skills training sessions including referral, familiarity with osteoporosis, exchange of colostomy bag, diet in osteoporosis patients, exercise and daily activity, and practical evaluation of interventional group for replacing osteoarthritis in 6 training sessions of 45 minutes prior to Surgery was conducted with pamphlets and educational videos</i_keyword>
      <i_keyword>Control group: The control group consisted of 18 children with ostoma (8-12 years old) admitted to selected hospitals in Tehran who did not receive any training on self care skills.</i_keyword>
      <i_keyword>Intervention group: The intervention group consisted of 18 children with ostoma (8-12 years old) admitted to selected hospitals in Tehran who were trained in self-care skills in 6 sessions of 45 minutes (familiarity with ostoma, how to exchange colostomy bag, diet in ostomates, exercise and Daily activities)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life. Timepoint: Before, immediately and one month after the intervention. Method of measurement: Kindle Children's Quality of Life Questionnaire.</prim_outcome>
      <prim_outcome>Self esteem. Timepoint: Pre-intervention, immediately and one month after intervention. Method of measurement: Cooper Smith Self-Esteem 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 and Health Services</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-06-21</approval_date>
        <contact_name>College of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences and Health Services</contact_name>
        <contact_address>Tehran, Valiasr Ave., Shahid Abbaspour Street, next to Paul Hemmat, No. 19 tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
