<?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>IRCT20180408039234N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-01</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>The effect of self-care on improving the health of postmenopausal women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Self-care education on health promoting lifestyle in postmenopausal women in Qazvin in 1997</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30561</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The study will use a multi-stage sampling method. First, the city of Qazvin, according to its urban areas, is divided into 3 urban areas and one of the centers of urban health in each region is randomly selected cluster center and from among postmenopausal women referring to these centers The available form will be sampled and women will be included in the study if they meet the criteria for entering the study after completing the written consent. They are then randomly allocated into two groups of intervention and control, in which 84 pieces of paper are written on half of that control word and the other half of the intervention written by the person after signing the consent from one of the envelopes of the paper. has it, Blinding description: Blind technique is used to reduce possible bias in the results. Blindness should be done correctly, ie groups that have the potential to cause bias in the study, our study priority is to be blinded one by one and the information analyst is not aware of the control or interference of the samples. Samples in both groups are aware of which groups are in the study. The researcher also has the knowledge to provide the training in the intervention group.The information analyzer receives information in the form of numerical codes in two groups, because their control or intervention is unknown.</study_design>
      <phase>3</phase>
      <hc_freetext>Lifestyle Improvement Health.</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group:" Education sessions for postmenopausal women will be based on the sub-scales of the health promotion lifestyle questionnaire. These scales include nutrition, physical activity, stress management, health responsibility, interpersonal relationships, and spiritual growth. The training sessions will take place in four sessions in four weeks, and the duration of the sessions is 60 to 90 minutes. The sessions will be held in groups of 12 to 5, and at the end of each meeting, questions will be answered as needed. To increase the impact of education and help to get a better understanding of the booklet in this area related to the topics discussed. In this curriculum, the self-care education content of the Ministry of Health and Medical Education, which is provided by the Vice-Chancellor, and the Clinical Guide and Executive Program of the Health Team for the provision of menopause services to women aged 45-60, will be used as a teacher's guide. Also, in order to better understand the concepts, part of the training was a question and answer. At the end of each session, a brief educational pamphlet will be provided to the participants on the content presented at the meeting. This training will be carried out in Qazvin comprehensive health centers. In the intervention group, filling in the health promotion lifestyle questionnaire will be done one and two and three months after the end of the intervention. Intervention 2: Control group: Control group: In this group, receiving routine care provided by comprehensive health centers. At the beginning of the study, filling in the health promotion lifestyle questionnaire, and repeating this questionnaire in one and two and three months later.</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>Reyhana Sadat Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin University of Medical Sciences، Shahid Bahonar Blvd، Qazvin</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1696815479</zip>
        <telephone>+98 28 3323 7267</telephone>
        <email>reihane.mmw@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reyhana Sadat Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin University of Medical Sciences، Shahid Bahonar Blvd،Qazvin</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1696815479</zip>
        <telephone>+98 28 3323 7267</telephone>
        <email>reihane.mmw@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Postmenopausal natural
Pass one year of the last menstruation
Not participating in other similar studies
Calling number to track
Ability to speak Persian
At least 45 years old</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Taking any alternative hormone drugs in the last 3 months or during the study
Get any training on menopause, in other ways
Need for surgical intervention
Mental illness, according to a person in the last 6 months
The appearance of any spotting in the last year
Use of alcohol or tobacco (cigarettes, hookahs, etc.)
Use a special diet (water therapy, vegetarianism, raw food, etc.)</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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Intervention group:" Education sessions for postmenopausal women will be based on the sub-scales of the health promotion lifestyle questionnaire. These scales include nutrition, physical activity, stress management, health responsibility, interpersonal relationships, and spiritual growth. The training sessions will take place in four sessions in four weeks, and the duration of the sessions is 60 to 90 minutes. The sessions will be held in groups of 12 to 5, and at the end of each meeting, questions will be answered as needed. To increase the impact of education and help to get a better understanding of the booklet in this area related to the topics discussed. In this curriculum, the self-care education content of the Ministry of Health and Medical Education, which is provided by the Vice-Chancellor, and the Clinical Guide and Executive Program of the Health Team for the provision of menopause services to women aged 45-60, will be used as a teacher's guide. Also, in order to better understand the concepts, part of the training was a question and answer. At the end of each session, a brief educational pamphlet will be provided to the participants on the content presented at the meeting. This training will be carried out in Qazvin comprehensive health centers. In the intervention group, filling in the health promotion lifestyle questionnaire will be done one and two and three months after the end of the intervention.</i_keyword>
      <i_keyword>Control group: Control group: In this group, receiving routine care provided by comprehensive health centers. At the beginning of the study, filling in the health promotion lifestyle questionnaire, and repeating this questionnaire in one and two and three months later.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lifestyle Improvement Health. Timepoint: At the beginning of the study (before the intervention), one month and a half and three months later. Method of measurement: Health Promotion Lifestyle Assessment 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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-04</approval_date>
        <contact_name>Ethics Committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Unit 21،  Sepid Tower، Arash Alley، Farhangian Alley،Noobhar Street، Azhgol، Tehran Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
