<?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>IRCT20200708048061N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-06</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Investigating theeffect of training on self-efficacy and lifestyle of ostomates</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of self care education  on self-efficacy and life style of patients with an intestinal  ostoma</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>74</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49542</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Sampling will be continuous at the sample section stage and then a simple random method will be used to distribute the samples to the intervention and control groups. The samples will be distributed to two groups of intervention and control by a third party who is unaware of the study flow using the table of random numbers.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patient with gastrointestinal ostomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The samples will be distributed to the intervention and control groups by a third person who is unaware of the study using a random number table. The pre-test in the intervention group will include lifestyle tools and ostomy self-efficacy tools. Then, based on the educational needs of the patients under study and in accordance with these needs, a face-to-face training program using an educational booklet and lectures in the field (ostomy care, skin care around the ostomy, bag replacement, diet, activity and exercise, sexual activity, Travel, bathing and swimming).The training program will be done in 4 sessions of 45 minutes. After the training sessions, the educational content will be followed up by the researcher by phone every 15 days. After 50 days, the samples will be re-completed at the medical centers and the completed tools will be re-tested as a pre-test. Intervention 2: Control group: The control group will receive routine training by medical staff at the same time as the pre-test group. In the control group, routine hospital follow-ups will be performed. After 50 days in the control group, a post-test is taken and finally the educational booklet is delivered to this group.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Some of the unidentifiable information is the data that can be shared after the end of the study.

When:
Access starts 6 months after the results are published

To whom:
Researchers working in academic and scientific institutions

Conditions:
The documentation can only be used for review in research.

Where to obtain:
Fatemeh Yousefli
Phone number 09369903979
Email adress: fatemeh.yousefli711116@gmail.com

How to obtain:
After the applicant's request via email, the request will be submitted to the tutor and if she agrees, the request data will be sent via email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Yousefli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ebne Sina Hospital, at the beginning of Ayatollah Kashani Highway, Sadeghieh 2nd Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1481795693</zip>
        <telephone>+98 21 4790 1133</telephone>
        <email>fatemeh.yousefli711116@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fariba Nasiri Ziba</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iranian School of Nursing and Midwifery., Rashid Yasemi St.,  Above Vanak Sq., Valiasr St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 4365 1000</telephone>
        <email>fariba_nz@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>At least one month after ostomy implanation
Age between 18-65
Literacy for reading and writing
Lack of psychiatric disorders
Failure to attend self-care training sessions in the last six month
Ability to communicate
Ability to collaborate</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Withdrawal from continuing research
Absence in two sessions of training sessions
Participate in self-care training sessions while participating in research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_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: The samples will be distributed to the intervention and control groups by a third person who is unaware of the study using a random number table. The pre-test in the intervention group will include lifestyle tools and ostomy self-efficacy tools. Then, based on the educational needs of the patients under study and in accordance with these needs, a face-to-face training program using an educational booklet and lectures in the field (ostomy care, skin care around the ostomy, bag replacement, diet, activity and exercise, sexual activity, Travel, bathing and swimming).The training program will be done in 4 sessions of 45 minutes. After the training sessions, the educational content will be followed up by the researcher by phone every 15 days. After 50 days, the samples will be re-completed at the medical centers and the completed tools will be re-tested as a pre-test.</i_keyword>
      <i_keyword>Control group: The control group will receive routine training by medical staff at the same time as the pre-test group. In the control group, routine hospital follow-ups will be performed. After 50 days in the control group, a post-test is taken and finally the educational booklet is delivered to this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ostomy self-efficacy score higher than 42. Timepoint: Measurement of self-efficacy  level before intervention and 50 days after. Method of measurement: How to measure the self-efficacy variable is the ostomy self-efficacy questionnaire.</prim_outcome>
      <prim_outcome>Lifestyle score above 140. Timepoint: Measuring lifestyle level before the medal and 50 days later. Method of measurement: General Lifestyle Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>This study has no secondary outcome variables. Timepoint: This study has no secondary outcome variables. Method of measurement: This study has no secondary outcome variables.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-22</approval_date>
        <contact_name>Ethics Committee in Biomedical Research</contact_name>
        <contact_address>Ebne Sina Hospital, The beginning of Ayatollah Kashani Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
