<?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>IRCT20191125045489N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-27</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>The effect of midwifery counseling  on menopausal complications and marital conflicts</public_title>
      <acronym></acronym>
      <scientific_title>The effect of midwifery counseling with Solution-based approach on menopausal complications and marital conflicts in menopausal women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43748</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Once participants in research are determined, they are randomly assigned into intervention and control group using four blokes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Women Menopause Complications. Condition 2: Marital Conflict of Menopausal Women.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:The training program for the intervention group will be presented in 6 sessions for 90 minutes. The intervention principle in the intervention group is on the basis of the effectiveness of midwifery counseling will be with a solution-based approach . The training of menopausal women will be done according to the protocol presented in two group of 25 participants. During the training session, combination methods such as lecture, face-to-face teaching, group discussion are used. The idea that change is inevitable is the basis of solution-based consulting. Small changes provide the basis for big changes. Example of techniques used in solution-based therapy,  Exceptions and miraculous questions techniques is using. For example,  client are asked: when there is no problem? or What time you're better off? or , For example, if you fall asleep tonight and a miracle happens while you sleep and your problem will be solved, what do you think is the first sign to show what a miracle has happened?. solution-based therapy helps client find other ways to think, feel and behave instead of what he has done so far with the important word "instead". Solution-based treatment is based on the assumption that people are healthy and competent, and they have the ability to create solutions that improve their lives. So the basic strategy is the therapist's initiative to identify their abilities. The solution-based treatment process usually involves five steps: 1- Identify the problem and the purpose, 2- Identify and increase exceptions, 3- Interventions or tasks designed to identify and increase exceptions, 4- Assess the impact of interventions, 5- Reassess the problem and purpose, In this project we will use the solution-based protocol and the title of the meetings is as follows: 1- First session: Getting to know and confidence of participating women. 2- Second session: Investigating the goals of women, 3- Third session: Empowering women and identifying exceptions, Fourth session: Helping women find new ways and express miracle questions, 5- Fifth session: Creating solutions and fixing them, 6- Sixth session: Summing up and concluding all sessions . Intervention 2: Control group: A 3-session training course will be provided according to the research ethics in order to thank the control group attendance.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is The study is not finished yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fereshteh Naeimifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.10, Sajajid Ally, south Iranzamin ST.,  Mokhbery St.,  Ponak Square, Tehran Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1476613691</zip>
        <telephone>+98 21 4449 5826</telephone>
        <email>f.naimifar50@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahrbano Salehin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahroud University of Medical Sciences, Haft Tir Square, Shahroud</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614773955</zip>
        <telephone>+98 23 3239 5018</telephone>
        <email>drbsalehin@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Married women
Women who have sex
Women aged between 45 to 60
Women with menopausal complications
Women who can write and read in persian
Women who are consenting to participate in this project
Lack of severe illness that may interfere with sex</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Women who did not attend more than one session
Women who have premature menopause before the age of forty
Women who have had  hysterectomy and oophorectomy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_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:The training program for the intervention group will be presented in 6 sessions for 90 minutes. The intervention principle in the intervention group is on the basis of the effectiveness of midwifery counseling will be with a solution-based approach . The training of menopausal women will be done according to the protocol presented in two group of 25 participants. During the training session, combination methods such as lecture, face-to-face teaching, group discussion are used. The idea that change is inevitable is the basis of solution-based consulting. Small changes provide the basis for big changes. Example of techniques used in solution-based therapy,  Exceptions and miraculous questions techniques is using. For example,  client are asked: when there is no problem? or What time you're better off? or , For example, if you fall asleep tonight and a miracle happens while you sleep and your problem will be solved, what do you think is the first sign to show what a miracle has happened?. solution-based therapy helps client find other ways to think, feel and behave instead of what he has done so far with the important word "instead". Solution-based treatment is based on the assumption that people are healthy and competent, and they have the ability to create solutions that improve their lives. So the basic strategy is the therapist's initiative to identify their abilities. The solution-based treatment process usually involves five steps: 1- Identify the problem and the purpose, 2- Identify and increase exceptions, 3- Interventions or tasks designed to identify and increase exceptions, 4- Assess the impact of interventions, 5- Reassess the problem and purpose, In this project we will use the solution-based protocol and the title of the meetings is as follows: 1- First session: Getting to know and confidence of participating women. 2- Second session: Investigating the goals of women, 3- Third session: Empowering women and identifying exceptions, Fourth session: Helping women find new ways and express miracle questions, 5- Fifth session: Creating solutions and fixing them, 6- Sixth session: Summing up and concluding all sessions .</i_keyword>
      <i_keyword>Control group: A 3-session training course will be provided according to the research ethics in order to thank the control group attendance</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Menopausal Complications Score in the Menopause symptoms severity Inventory-38 Questionnaire. Timepoint: Before intervention, One week after intervention, One month after intervention. Method of measurement: Menopause symptoms severity Inventory-38 Questionnaire.</prim_outcome>
      <prim_outcome>Menopausal Marital Conflict Score in Marital Conflict Questionnaire. Timepoint: Before intervention, One week after intervention, One month after intervention. Method of measurement: Marital conflict 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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-21</approval_date>
        <contact_name>Ethics committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>University of Medical Sciences, Haft Tir square, Shahroud Town Shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
