<?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>IRCT20190206042640N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-04-21</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>The effect of educational intervention on improving the quality of life among postmenopausal women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of educational intervention based on multi-theory model on improving the quality of life among postmenopausal women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37370</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: Health centers in Yazd will be selected using a multi-stage random sampling method. In the first stage, based on the socioeconomic status, the health centers of Yazd are divided into 3 categories (areas with weak, moderate and good socioeconomic status), then from each health centers in the area with good socioeconomic status (2) Center), medium (2 centers) and weak (2 centers) will be randomly selected. Then, three centers (from all three areas of good, moderate and weak) will be randomly assigned as intervention group and three centers (from all three areas) will be considered as the control group. Blocked randomization method with sizes 4 and 6 through statistical software will be used to determine the number of required sample sizes (which will subsequently be identified) to randomly assign the intervention to the two groups of subjects. Eligible Individual to study before a randomization is assigned a code. In order to hide the randomization, after the randomization by the researcher, the codes will be notified by telephone to the responsible training and implementation of the intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>menopause.</hc_freetext>
      <i_freetext>Intervention 1: The women in the intervention group will participate in 12 one-hour training sessions on the symptoms, nature, complications of menopause and ways to adapt to menopause, facial expressions, lectures, showing film, questions and answers, and will provide them with an educational booklet. . Based on the multi-theoretical model for the participatory dialogue structure, group discussion sessions to discuss the benefits and disadvantages of behavior change, for behavioral confidence construct, self-esteem skills training, for the structure of change in the physical environment Lobbying with organizations such as the Sports and Youth Department, the Municipality and etc, to allocate half-price tickets and sports equipment, for emotional transformation, it will be modified  by the role playing by postmenopausal women for stimulating their emotions, about Practice for change Construct, a notebook for all the behaviors that they must follow will be prepare And for the change in social environment, the educational sessions will be held separately through showing film and lectures for spouses and children of postmenopausal women. Intervention 2: Control group: no intervention for women in the control group will be held. Only in order to observe ethical consideration, at the end of the study, the educational booklet will be give to women in 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>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 No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nooshin Yoshany</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Safaeiyeh</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173160</zip>
        <telephone>+98 35 3623 5079</telephone>
        <email>nooshin.yoshany@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nooshin Yoshany</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Safaeiyeh</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173160</zip>
        <telephone>+98 35 3623 5079</telephone>
        <email>nooshin.yoshany@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>passing 1-5 years from menopause
having natural menopause
lack of disabling illness, physical disability (such as hearing &amp; Sight impairment) and impaired consciousness
being between 45-55 years old
lack of addiction
Women are willing to participate in the research and confirm the written and informed consent form.
Women have not participated in any menopause training course since six months ago.</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Menopause caused by hysterectomy and oophorectomy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N95</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Menopausal and other perimenopausal disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The women in the intervention group will participate in 12 one-hour training sessions on the symptoms, nature, complications of menopause and ways to adapt to menopause, facial expressions, lectures, showing film, questions and answers, and will provide them with an educational booklet. . Based on the multi-theoretical model for the participatory dialogue structure, group discussion sessions to discuss the benefits and disadvantages of behavior change, for behavioral confidence construct, self-esteem skills training, for the structure of change in the physical environment Lobbying with organizations such as the Sports and Youth Department, the Municipality and etc, to allocate half-price tickets and sports equipment, for emotional transformation, it will be modified  by the role playing by postmenopausal women for stimulating their emotions, about Practice for change Construct, a notebook for all the behaviors that they must follow will be prepare And for the change in social environment, the educational sessions will be held separately through showing film and lectures for spouses and children of postmenopausal women</i_keyword>
      <i_keyword>Control group: no intervention for women in the control group will be held. Only in order to observe ethical consideration, at the end of the study, the educational booklet will be give to women in control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: Before and two months after training. Method of measurement: MENQOL questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Menopause coping. Timepoint: Before and two months after training. Method of measurement: Researcher made 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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-02</approval_date>
        <contact_name>Ethic's committee of school of public health - Shahid Sadoughi university of medical sciences</contact_name>
        <contact_address>Alem squer Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
