<?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>IRCT2014113020162N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-04-04</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Ostomy care education to patients with intestinal ostomy</public_title>
      <acronym></acronym>
      <scientific_title>Comparitive study on the effects of simulation and demonstration-return demonstration methods in ostomy care training on self-efficacy and adjustment in patients with an intestinal stoma</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-04-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17879</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ineffective training.</hc_freetext>
      <i_freetext>Intervention 1: Intervention1: The demonstration- return demonstration ostomy care training is done in 4 sessions, in the first session teach about the types of ostomy, diet, bathing, authorized and unauthorized activities and warning signs, gas and odor control in colostomy, signs and symptoms of dehydration and The importance of leakage prevention. In the second session, patient educated about how to change the ostomy pouch and care of skin that around the ostomy  with demonstration method and patient practice cutting ostomy bag by return demonstration. This session held 1-3 days after the first session. In third session, patient change ostomy pouch and skin care around the ostomy without nurse aid by return demonstration. Researcher completes teaching flow sheet. The session will be held one week after the second session. In the fourth session common complication of ostomy and how to prevent them educated by PowerPoint software. The group members discuss and respond to each other’s questions. The meeting will be held one week after the third session. Intervention 2: intervention2: The simulation ostomy care training is done in 4 sessions, in the first session teach about the types of ostomy, diet, bathing, authorized and unauthorized activities and warning signs, gas and odor control in colostomy, signs and symptoms of dehydration The importance of leakage prevention leakage. Then video will be witch contains ostomy bag substitute teaching and patient practice how to cut the adhesive ostomy bag. In the second session patient learning how to change the ostomy pouch and skin care around the ostomy. Patient participates in Skin care with the physical simulators. The session will be held 1-3 days after the first session. In the fourth session common complication of ostomy and how to prevent them educated by PowerPoint software. The meeting will be held one week after the third session.</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>Zohre Pouresmail</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Number 69,South Adibe 1 St, Ghasem abad, Mashhad.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9189633798</zip>
        <telephone>+98 935 539 2288</telephone>
        <email>pouresmailz921@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sience</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Heshmati Nabavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Doctora Crossroads, Mashhad.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 915 500 2213</telephone>
        <email>heshmatinf@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sience</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria for patients recently have ostomy surgery: Between 18 and 65 years old; Patient that Singed Consent Knowingly; Having healthy vision and hearing and having no disability; Have no psychological disease, movement disability and balance disorders; Have no experience of having intestinal ostomy in family members; Do not receive any regular and documented ostomy training.&#13;
Inclusion criteria for patients who already have ostomy surgery: Between 18 and 65 years old; Patient that Singed Consent Knowingly. Exclusion criteria: Willingness to continue participation in the study; Complications that commonly affect the Regular care and need to hospitalization; Patient death</inclusion_criteria>
      <agemin>17 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z55.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>other problems related to education and literacy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention1: The demonstration- return demonstration ostomy care training is done in 4 sessions, in the first session teach about the types of ostomy, diet, bathing, authorized and unauthorized activities and warning signs, gas and odor control in colostomy, signs and symptoms of dehydration and The importance of leakage prevention. In the second session, patient educated about how to change the ostomy pouch and care of skin that around the ostomy  with demonstration method and patient practice cutting ostomy bag by return demonstration. This session held 1-3 days after the first session. In third session, patient change ostomy pouch and skin care around the ostomy without nurse aid by return demonstration. Researcher completes teaching flow sheet. The session will be held one week after the second session. In the fourth session common complication of ostomy and how to prevent them educated by PowerPoint software. The group members discuss and respond to each other’s questions. The meeting will be held one week after the third session.</i_keyword>
      <i_keyword>intervention2: The simulation ostomy care training is done in 4 sessions, in the first session teach about the types of ostomy, diet, bathing, authorized and unauthorized activities and warning signs, gas and odor control in colostomy, signs and symptoms of dehydration The importance of leakage prevention leakage. Then video will be witch contains ostomy bag substitute teaching and patient practice how to cut the adhesive ostomy bag. In the second session patient learning how to change the ostomy pouch and skin care around the ostomy. Patient participates in Skin care with the physical simulators. The session will be held 1-3 days after the first session. In the fourth session common complication of ostomy and how to prevent them educated by PowerPoint software. The meeting will be held one week after the third session.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self efficacy. Timepoint: Before the intervention, after the intervention, 1.5 month after intervention. Method of measurement: self efficacy questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Adjustment. Timepoint: Before the intervention,After the intervention, 1.5 month after intervention. Method of measurement: Ostomy adjusment inventory 23 questionnaire.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-03-14</approval_date>
        <contact_name>Mashhad University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for research, Ghoraishy Building, University St, Mashhad Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
