<?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>IRCT20171205037754N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-01</date_registration>
      <primary_sponsor>Vice-Chancellor for Research in Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>The effect of training in two traditional ways and using an educational model on Kagel exercises</public_title>
      <acronym></acronym>
      <scientific_title>: Comparison the effect of traditional health education with health beliefe model education on Kegel exercises in middle age women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29213</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Other, Randomization description: Individuals will be randomly divided into two groups of 50. Samples will be selected from sampled patients from the referrals to the clinic after the initial interview and according to the criteria for entering and leaving the study. Then, through a random table, numbers will be grouped into two groups, each with one code (from one to one hundred), and then selecting them one by one, for example, one in the test group And the number two will be in the control group. Finally, 50 people will receive health-based education and 50 routine care and traditional training in health centers, Blinding description: The blinded two-way sampling method was used in which the questionnaires were not conducted by an educator who was not included in the type of groups once before the intervention, and then two months after entering the study for both groups, which they also informed about the title The team will not complete and the checklists will be delivered. And data analysis will be performed by the assessor who knows the control and intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pelvic floor muscle weakness.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: A 45-30 year old spouse with a birth history-In the intervention group, an educational program based on the health belief model will be implemented. The training intervention will take place in four sessions in the form of lectures, questions and answers, group discussion and practical presentation. At the end of the fourth session, a training booklet will be provided on Kegel exercise, including the items taught in these 4 sessions. The purpose of this booklet is to provide guidance, increased perceived sensitivity, perceived severity, perceived benefits and self-efficacy, and reduced perceived barriers. Also, a checklist will be given to the recipients for the two months to be recorded. At the end of every two weeks, callers will be contacted and talk about the problems with the intervention. Intervention 2: Control group: The control group will be selected according to the same criteria as the study group that the test group will then complete and then the questionnaire will be completed by clinical carers. Then they will be given to the control group by the clinical guards of Kegel training in the traditional way and three months later they will be asked to They will be returned to them again by clinical caregivers.</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:
The spss file, the data and statistical analysis through it, as well as the final tables of the conclusions discussed in the chapters of these five theses, will be made available to this site as necessary

When:
1/5/97-1/6/97

To whom:
Medical students

Conditions:
For use in research project

Where to obtain:
Writer

How to obtain:
Via the valid email provided in the previous sections

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>nezal AJ</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahonar Blvd.-Qazvin University of Medical Sciences</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>36711-34319</zip>
        <telephone>+98 28 3333 7006</telephone>
        <email>nezal_ajh@yahoo.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>nezal AJ</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahonar Blvd.-Qazvin University of Medical Sciences</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>36711-34319</zip>
        <telephone>+98 28 3333 7006</telephone>
        <email>nezal_ajh@yahoo.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Middle aged women 30 - 45 years old
married
have a child or more
have a normal birth history that is more at risk for pelvic prolapse</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>People with proven pelvic prolapse
and chronic diseases include high blood pressure, diabetes, cardiovascular, pulmonary, renal
psychiatric patients with a history of drug therapy</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>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: A 45-30 year old spouse with a birth history-In the intervention group, an educational program based on the health belief model will be implemented. The training intervention will take place in four sessions in the form of lectures, questions and answers, group discussion and practical presentation. At the end of the fourth session, a training booklet will be provided on Kegel exercise, including the items taught in these 4 sessions. The purpose of this booklet is to provide guidance, increased perceived sensitivity, perceived severity, perceived benefits and self-efficacy, and reduced perceived barriers. Also, a checklist will be given to the recipients for the two months to be recorded. At the end of every two weeks, callers will be contacted and talk about the problems with the intervention.</i_keyword>
      <i_keyword>Control group: The control group will be selected according to the same criteria as the study group that the test group will then complete and then the questionnaire will be completed by clinical carers. Then they will be given to the control group by the clinical guards of Kegel training in the traditional way and three months later they will be asked to They will be returned to them again by clinical caregivers</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Perform Cogel exercises. Timepoint: Before and after intervention. Method of measurement: A checklist - a questionnaire.</prim_outcome>
      <prim_outcome>Perceived sensitivity. Timepoint: Before and after intervention. Method of measurement: a questionnaire.</prim_outcome>
      <prim_outcome>Perceived severity. Timepoint: Before and after intervention. Method of measurement: a questionnaire.</prim_outcome>
      <prim_outcome>Perceived benefits. Timepoint: Before and after intervention. Method of measurement: a questionnaire.</prim_outcome>
      <prim_outcome>Perceived barriers. Timepoint: Before and after intervention. Method of measurement: a questionnaire.</prim_outcome>
      <prim_outcome>Action guide. Timepoint: Before and after intervention. Method of measurement: a questionnaire.</prim_outcome>
      <prim_outcome>Efficacy. Timepoint: Before and after intervention. Method of measurement: a questionnaire.</prim_outcome>
      <prim_outcome>Awareness. Timepoint: Before and after intervention. Method of measurement: a 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>Vice-Chancellor for Research in Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-11-03</approval_date>
        <contact_name>Ghazvin University of Medical Sciences</contact_name>
        <contact_address>Bahonar Blvd.-Qazvin University of Medical Sciences Ghazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
