<?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>IRCT20230716058792N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-14</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The impact of the empowerment program on the health and quality of life of postmenopausal women</public_title>
      <acronym></acronym>
      <scientific_title>Designing and evaluating the impact of the empowerment program on the health and quality of life of postmenopausal women: The application of the PRECEDE‑PROCEED model and the Longwe empowerment framework</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71544</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: With the formation of the elite panel and based on their opinions, 43 health centers in Shiraz are considered and divided into three groups of health centers in prosperous (rich), medium urban (relatively rich) and undeveloped (less rich) areas. In this study, the health centers of Shiraz city were selected as clusters, which were randomly selected using NCSS-PASS version 15 (2020) software from each of the 2 cluster areas, and were selected as control and intervention groups using randomization allocation method with equal blocks of each of these 2 clusters. Then, by referring to the selected health centers and reviewing the records of postmenopausal women covered by the center, postmenopausal women eligible to participate in the study will be invited by telephone to participate in the research project with consecutive sampling until the desired sample size is reached in each cluster.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Menopause.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The educational program for the intervention group is designed to cater to their specific needs and literacy levels. It is conducted through face-to-face meetings, lasting 90 minutes each, once a week. The timing of these meetings is agreed upon by the participants. The sessions are conducted in a collaborative manner, with group discussions focusing on problem-solving and feedback provision.The participants are provided with a booklet that contains information on various aspects related to menopause. This includes education on menopause symptoms, healthy nutrition, physical activity, menopause health, seeking healthcare, and social support. The content of the booklet is based on the guidelines provided by the Office of Education and Health Promotion as well as the Office of Population, Family Health, and Madrasa under the deputy health department of Iran's Ministry of Health, Treatment, and Medical Education. Intervention 2: Control group: No intervention is performed and they only receive routine care. However, after the last post-test, they will be provided with an educational booklet aimed at increasing their knowledge about menopause and self-care practices during this period.</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:
All data is potentially shareable after de-identifying individuals.

When:
The access period starts 6 months after the results are published.

To whom:
Researchers working in academic and scientific institutions.

Conditions:
Confirmation of Professor Mohammad Hossein Kaveh.

Where to obtain:
Kaveh@sums.ac.ir

How to obtain:
Through the corresponding author of the articles within a period of 1 week to 1 month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Khadijeh Khademi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Health school., Razi Blvd.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7153675541</zip>
        <telephone>+98 71 3725 1005</telephone>
        <email>khademikhadijeh@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Hossein Kaveh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Health school., Razi Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7153675541</zip>
        <telephone>+98 71 3725 1005</telephone>
        <email>Kaveh@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be between the ages of 45 and 65.
According to the scientific definition, they are considered menopause.
At least one year has passed since their menopause.
Have reading and writing literacy at least the end of the third grade or equivalent or higher.
To participate in the study, declare your agreement and sign the informed consent form.</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>under the care of a psychiatrist due to suffering from mental illnesses.
Suffering from chronic diseases (including diabetes, hypertension, heart failure, kidney failure) and cancer.
Use of hormone therapy during the last 6 months.
History of hysterectomy and oophorectomy.
Suffering from abnormal vaginal bleeding.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N95.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Menopausal and female climacteric states</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The educational program for the intervention group is designed to cater to their specific needs and literacy levels. It is conducted through face-to-face meetings, lasting 90 minutes each, once a week. The timing of these meetings is agreed upon by the participants. The sessions are conducted in a collaborative manner, with group discussions focusing on problem-solving and feedback provision.The participants are provided with a booklet that contains information on various aspects related to menopause. This includes education on menopause symptoms, healthy nutrition, physical activity, menopause health, seeking healthcare, and social support. The content of the booklet is based on the guidelines provided by the Office of Education and Health Promotion as well as the Office of Population, Family Health, and Madrasa under the deputy health department of Iran's Ministry of Health, Treatment, and Medical Education.</i_keyword>
      <i_keyword>Control group: No intervention is performed and they only receive routine care. However, after the last post-test, they will be provided with an educational booklet aimed at increasing their knowledge about menopause and self-care practices during this period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life score in World Health Organization Questionnaire. Timepoint: Before, 2 weeks and 4 months after the educational intervention. Method of measurement: World Health Organization Quality of Life Questionnaire.</prim_outcome>
      <prim_outcome>Health score in Women's Health Questionnaire. Timepoint: Before, 2 weeks and 4 months after the educational intervention. Method of measurement: Women's Health Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Self-care score in Menopause Self-care Questionnaire. Timepoint: Before, 2 weeks and 4 months after the educational intervention. Method of measurement: Menopause Self-care Questionnaire.</sec_outcome>
      <sec_outcome>The score of knowledge and attitude towards menopause in the knowledge and attitude towards menopause questionnaire. Timepoint: Before, 2 weeks and 4 months after the educational intervention. Method of measurement: knowledge and attitude towards menopause questionnaire.</sec_outcome>
      <sec_outcome>Self-care knowledge and attitude score in self-care knowledge and attitude questionnaire. Timepoint: Before, 2 weeks and 4 months after the educational intervention. Method of measurement: Self-care knowledge and attitude questionnaire.</sec_outcome>
      <sec_outcome>Self-efficacy score in the General Self-Efficacy beliefs Scale. Timepoint: Before, 2 weeks and 4 months after the educational intervention. Method of measurement: General Self-Efficacy beliefs Scale.</sec_outcome>
      <sec_outcome>Perceived health control score in MHLC- C for postmenopausal women. Timepoint: Before, 2 weeks and 4 months after the educational intervention. Method of measurement: MHLC- C for postmenopausal women.</sec_outcome>
      <sec_outcome>Social support score in MSPSS. Timepoint: Before, 2 weeks and 4 months after the educational intervention. Method of measurement: MSPSS.</sec_outcome>
      <sec_outcome>The score of enabling factors in the women's perceived health enablers questionnaire. Timepoint: Before, 2 weeks and 4 months after the educational intervention. Method of measurement: women's perceived health enablers 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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-25</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Health school., Razi Blvd. Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
