<?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>IRCT20211205053281N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-30</date_registration>
      <primary_sponsor>Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of training couples communication skills using multimedia software on menopausal symptoms, quality of life and marital satisfaction</public_title>
      <acronym></acronym>
      <scientific_title>The effect of couple communication skills training using multimedia software on menopausal symptoms, quality of life and marital satisfaction among women in menopausal transition</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60535</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: 2 Comprehensive centers for providing health services based on the lottery, will be assigned to intervention groups (training of couple communication skills using multimedia software) and control group (one center each). Then in the centers, samples will be entered into the study based on available (easy) sampling. Randomization is simple and the randomization units are clustered and randomization is done by tossing coins.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Menopausal and other perimenopausal disorders.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Forming an intervention group in WhatsApp software, conducting training programs in 6 sections (2 hours each section) during two sessions per week for the participants of the intervention group. Intervention in the multimedia group will be as follows: A schedule will be provided to the intervention group, according to which the training sections will be sent to them in WhatsApp messenger (separately for each couple). Each educational section will include educational materials prepared according to the program along with images, audio, content, videos, etc., which will help to better understand the content. The scientific content of the educational program sections will be prepared using the latest reference books and also according to the content of the booklets and educational materials published by the Ministry of Health and Medical Education and will be available to 10 reproductive health specialists and gynecologists for approval. And counseling will be included. The topics of the sessions include: introducing the expression of goals and methods of work, self-awareness, recognizing the healthy personality, the importance of self-confidence, marital life skills, heart dialogue, intimacy, love commitment, intimacy, resilience conflict, satisfying sexual relaxation. Intervention 2: Control group: Form a control group in WhatsApp software. Only PDF tutorials are included in this group and also three questionnaires to complete.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Akram gholami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Phase Two Army</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9744163459</zip>
        <telephone>+98 56 3130 8772</telephone>
        <email>helya.gholami1397@gmail.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Narjes bahri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gonabad - Asian Roadside - University Campus</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>000000000000000</zip>
        <telephone>+98 51 5722 0575</telephone>
        <email>nargesbahri@yahoo.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>40-55 years old
having written consent to participate in the study
having literacy
having the ability to use WhatsApp messenger
being married and living with a spouse
not having hormone replacement therapy
no history of hysterectomy or ovariectomy
no Using herbal remedies to reduce menopausal symptoms
not being diagnosed with mental and sexual disorders (according to the participant)
not taking psychiatric drugs or addiction (according to the participant)
not having physical and ground disease In couples (such as cancer, cardiovascular disease, stroke)
no adverse life events in the last 6 months</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Untimely death of one of the spouses
absence of more than one session
unwillingness to continue studying</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>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Forming an intervention group in WhatsApp software, conducting training programs in 6 sections (2 hours each section) during two sessions per week for the participants of the intervention group. Intervention in the multimedia group will be as follows: A schedule will be provided to the intervention group, according to which the training sections will be sent to them in WhatsApp messenger (separately for each couple). Each educational section will include educational materials prepared according to the program along with images, audio, content, videos, etc., which will help to better understand the content. The scientific content of the educational program sections will be prepared using the latest reference books and also according to the content of the booklets and educational materials published by the Ministry of Health and Medical Education and will be available to 10 reproductive health specialists and gynecologists for approval. And counseling will be included. The topics of the sessions include: introducing the expression of goals and methods of work, self-awareness, recognizing the healthy personality, the importance of self-confidence, marital life skills, heart dialogue, intimacy, love commitment, intimacy, resilience conflict, satisfying sexual relaxation</i_keyword>
      <i_keyword>Control group: Form a control group in WhatsApp software. Only PDF tutorials are included in this group and also three questionnaires to complete</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of menopausal symptoms. Timepoint: At the beginning of the study, immediately after the intervention, three months after the intervention. Method of measurement: Menopause Symptoms Rating Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life. Timepoint: At the beginning of the study, immediately after the intervention, three months after the intervention. Method of measurement: Quality of life questionnaire.</sec_outcome>
      <sec_outcome>Marital Satisfaction. Timepoint: At the beginning of the study, immediately after the intervention, three months after the intervention. Method of measurement: Marital Satisfaction 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>Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-13</approval_date>
        <contact_name>Ethics Committee of Gonabad University of Medical Sciences</contact_name>
        <contact_address>Phase Two Army birjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
