<?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>IRCT20121208011691N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-14</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of self-care education on self-efficacy and happiness of elderly women with urinary incontinence</public_title>
      <acronym></acronym>
      <scientific_title>The effect of self-care education on self-efficacy and happiness of elderly women with urinary incontinence, referring to Jahandidegan association in Shiraz, 2018</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34996</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: In order to group the samples according to simple random assignment method, 2 cards (A, B) are assigned to each test and control group. Patients, without knowing each group card, can choose one of their two cards And then enter one of the test or control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Steress urinary incontinence. Condition 2: Uregent and mix urinary incontinence.</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group": Self-care education program consists of 5 sessions. Training classes are held for 60 minutes or more, as a participatory learning and lecture in a test group of 2 days a week. In the first session, getting acquainted with the participants, the distribution of the questionnaire, the definition of aging, the incidence of urinary incontinence and its problems are discussed. At the second session, self-care training on pelvic floor muscle and exercises to strengthen the pelvic floor muscle Became In the third session, the self-care education will be expressed on nutrition and drinks and how they are consumed and their effects, how to choose and consume food and drink. In the fourth session, the importance of the impact of disease management on happiness and self-efficacy of individuals is referred, as well as the use of educational materials to manage illness and increase self-esteem and disease control. Finally, the fifth session will summarize the issues and redistribute the questionnaire. In case of absence, a tutorial will be provided to the sample in a training session and the explanations will be given to them individually. If in the group They will have the opportunity to lower their understanding of the subject and level of education from other members of the group by using other teaching aids and placing more time for them, trying to convey and convey the material. Then immediately, two months after the end of training, the self-efficacy and happiness questionnaires will be completed by the samples in the test group. Intervention 2: "Control group": There is no intervention in this group. Pymflet and educational booklet will be provided to the control group. Then immediately, two months after the end of the training, the intervention group will complete the self-efficacy and happiness questionnaires by the samples in the control 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fariba Ghodsbin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz, Zand Avenue, Namazi Square, Faculty of Nursing and Midwifery, Hazrat Fatemeh (S)</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71348-14336</zip>
        <telephone>+98 0716474258</telephone>
        <email>ghodsbin@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fariba Ghodsbin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz, Zand Avenue, Namazi Square, Faculty of Nursing and Midwifery, Hazrat Fatemeh (S)</address>
        <city>shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71348-14336</zip>
        <telephone>+98 71 3647 4258</telephone>
        <email>ghodsbin@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ability to understand Persian language and communicate
Interested in participating in the study
Older women 60 years or more
Having urinary incontinence (stress, urgency, or both) for at least 6 months
Earn the minimum score of 4 and 6 respectively for stress incontinence and urgency
Ability to participate in sports programs related to urinary incontinence
Being alert (not having cognitive problems like dementia and alzheimer)</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>80 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Multiple Sclerosis
Diabetes
Parkinson's and Thrommers
Participate in similar training classes
History of urology and congenital urinary tract infections
The history of cancer related to genitourinary system</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N39.3</hc_code>
      <hc_code>N39.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stress incontinence (female)</hc_keyword>
      <hc_keyword>Other specified urinary incontinence</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Intervention group": Self-care education program consists of 5 sessions. Training classes are held for 60 minutes or more, as a participatory learning and lecture in a test group of 2 days a week. In the first session, getting acquainted with the participants, the distribution of the questionnaire, the definition of aging, the incidence of urinary incontinence and its problems are discussed. At the second session, self-care training on pelvic floor muscle and exercises to strengthen the pelvic floor muscle Became In the third session, the self-care education will be expressed on nutrition and drinks and how they are consumed and their effects, how to choose and consume food and drink. In the fourth session, the importance of the impact of disease management on happiness and self-efficacy of individuals is referred, as well as the use of educational materials to manage illness and increase self-esteem and disease control. Finally, the fifth session will summarize the issues and redistribute the questionnaire. In case of absence, a tutorial will be provided to the sample in a training session and the explanations will be given to them individually. If in the group They will have the opportunity to lower their understanding of the subject and level of education from other members of the group by using other teaching aids and placing more time for them, trying to convey and convey the material. Then immediately, two months after the end of training, the self-efficacy and happiness questionnaires will be completed by the samples in the test group.</i_keyword>
      <i_keyword>"Control group": There is no intervention in this group. Pymflet and educational booklet will be provided to the control group. Then immediately, two months after the end of the training, the intervention group will complete the self-efficacy and happiness questionnaires by the samples in the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-efficacy of pelvic floor muscle. Timepoint: Immediately and 2 months later. Method of measurement: Pelvic floor muscle self-efficacy questionnaire.</prim_outcome>
      <prim_outcome>Self-efficacy of chronic diseases. Timepoint: Immediately and 2 months later. Method of measurement: Self-efficacy questionnaire for chronic diseases ses6g.</prim_outcome>
      <prim_outcome>Happiness. Timepoint: Immediately and 2 months later. Method of measurement: Oxford Happiness Inventory.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-02</approval_date>
        <contact_name>Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Zand street Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
