<?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>IRCT20201226049833N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-05-28</date_registration>
      <primary_sponsor>Jeeroft University of Medical Sciences</primary_sponsor>
      <public_title>The effect of menopausal self-care application on the severity of menopausal symptoms in postmenopausal women</public_title>
      <acronym></acronym>
      <scientific_title>Designing a menopausal self-care application and examining its effect on the severity of menopausal symptoms in postmenopausal women referring to health centers in Jiroft in 2020</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53556</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: To assign people to two groups, cards called control A and intervention B will be designed and these cards will be placed in an envelope and the person will randomly pick up a card from the envelope. If he picks up card A, he enters the control group and if he picks up card B, he enters the intervention group.</study_design>
      <phase>3</phase>
      <hc_freetext>Severity of menopausal symptoms.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For members of the intervention group, an application made via Bluetooth will be installed on their smartphones and they will be taught how to use them. In fact, our study intervention is educational-consulting materials available in the application, which will be provided to the intervention group for 8 weeks.Content of educational-counseling materials in the form of multimedia contents such as video, image and audio and with graphic and visual features appropriate to the age group of adults, including education on physical and mental symptoms of postmenopausal women and ways to reduce them, nutrition, exercise, Personal hygiene, sexual issues, supplementation and danger signs of women in this period. No training session will be held.                             The application was designed and implemented with the cooperation of two gynecologists, two senior midwives, two psychiatrists, one medical informatics specialist and two software experts.In order to develop the application under the Android platform using the Java language, the technical requirements for this purpose will be identified and first the trial version and then the final version of the application will be created. The application can be easily installed and run with common hardware. Researchers will be in touch with members of the intervention group by telephone and will contact them twice a week, asking them to read the contents of the application, and if the members of the intervention group have any questions, They respond and encourage them to read the content in the app. Intervention 2: Control group: The created application will not be available to the control group and they will receive the usual care for postmenopausal women. Routine care includes care such as blood pressure control for all middle-aged men and women in health centers.</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:
After the data is not identifiable, part of the data related to the main outcome of the study will be published.

When:
Start of access period from article printing up to 6 months after

To whom:
The data will be available only to researchers working in academic and scientific institutions.

Conditions:
If you send a written request from the academic and scientific institutions, data file unrecognizable to them and they will be allowed to perform paired t-test, independent t-test, chi-square test and analysis of covariance are.

Where to obtain:
A written request should be sent by the University and Scientific Institute with the name and personal details to the e-mail address n.pourshahrokhi95@gmail.com.

How to obtain:
First, a written request will be sent to the mentioned e-mail address, and after reviewing the request by the relevant person, and within 2 weeks, the result will be sent to the requesting person via e-mail.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Neda Dastyar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jiroft - Shahed Square of Jiroft University of Medical Sciences and Health Services</address>
        <city>jiroft</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7861756447</zip>
        <telephone>+98 34 4331 6490</telephone>
        <email>dr.neda@yahoo.com</email>
        <affiliation>Jeeroft University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Neda Dastyar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jiroft - Shahed Square of Jiroft University of Medical Sciences and Health Services</address>
        <city>jiroft</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7861756447</zip>
        <telephone>+98 34 4331 6490</telephone>
        <email>dr.neda@yahoo.com</email>
        <affiliation>Jeeroft University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ages 45 to 60
Complete cessation of menstruation in the last 12 months without the use of medication or surgery
Literacy and access to smart phones</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Use any medication to reduce menopausal symptoms
Having any mental illness</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For members of the intervention group, an application made via Bluetooth will be installed on their smartphones and they will be taught how to use them. In fact, our study intervention is educational-consulting materials available in the application, which will be provided to the intervention group for 8 weeks.Content of educational-counseling materials in the form of multimedia contents such as video, image and audio and with graphic and visual features appropriate to the age group of adults, including education on physical and mental symptoms of postmenopausal women and ways to reduce them, nutrition, exercise, Personal hygiene, sexual issues, supplementation and danger signs of women in this period. No training session will be held.                             The application was designed and implemented with the cooperation of two gynecologists, two senior midwives, two psychiatrists, one medical informatics specialist and two software experts.In order to develop the application under the Android platform using the Java language, the technical requirements for this purpose will be identified and first the trial version and then the final version of the application will be created. The application can be easily installed and run with common hardware. Researchers will be in touch with members of the intervention group by telephone and will contact them twice a week, asking them to read the contents of the application, and if the members of the intervention group have any questions, They respond and encourage them to read the content in the app</i_keyword>
      <i_keyword>Control group: The created application will not be available to the control group and they will receive the usual care for postmenopausal women. Routine care includes care such as blood pressure control for all middle-aged men and women in health centers.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of menopausal symptoms. Timepoint: Before starting the study And after the intervention in two shifts, the second and eighth week will be measured. Method of measurement: Menopause Rating Scale (MRS).</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>Jeeroft University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-26</approval_date>
        <contact_name>Ethics Committee of Jiroft University of Medical Sciences</contact_name>
        <contact_address>Jiroft - Sepah Square - Nomadic Martyrs Building - Headquarters of Jiroft University of Medical Sciences and Health Services jiroft Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
