<?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>IRCT20161126031117N13</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-06</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of couple therapy counseling on the sexual function  in postmenopausal couples</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of the effectiveness of couple therapy counseling based on problem-solving and routine care on the sexual function in postmenopausal couples (couplepause)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69772</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Random block method will be used to assign samples to groups. In this method, similar couples (in terms of age, etc.) will be considered as blocks. Blocks will be considered as 4 blocks (2 pairs for each group) and finally 15 different blocks will be used to assign 60 pairs to two groups. The selection of the block type will be determined by the software program 2 Random Allocation, Blinding description: The evaluation of the consequences will be done by a colleague of the Citizen Project. The researcher, the evaluator and statistician do not know the group the participants belong to when evaluating the outcome.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: menopause. Condition 2: Andropause.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention sessions with the presence of couples will be conducted after completing the pre-test for 60 minutes and during 7 sessions with an interval of one week. People will be contacted once or twice a week to ensure that they complete their assignments. Immediately after the completion of the post-test intervention sessions and the follow-up and re-evaluation of the two groups in terms of sexual function (evaluation of the effectiveness of the treatment, couples' satisfaction with the results, handling of new or ongoing concerns) it will be 2 months later. Intervention 2: Control group: In the control group, after the completion of the study, during a session, pamphlets containing educational materials about menopause care and the role of men and women in supporting each other during menopause will be provided to them.</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:
The information related to the research is shared with the aim of keeping the names of the people and keeping their identities confidential and complying with the 31 code of ethics.

When:
Since 1402

To whom:
All researchers and those interested in research

Conditions:
To conduct review and supplementary research and for the use of therapists Menopausal couples

Where to obtain:
To receive documents or data, to the corresponding author by email
khanisog343@gmail.com and email of counseling student in midwifery with
Email mgoli7098@gmail.com can be accessed. At You can refer to the journal according to the journal's address to print the article.

How to obtain:
First, you must send an email to the author responsible for the article and your request put forward and, if appropriate, the responsible author and the research team Documents and files are provided in a short time.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marziye Goli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran Boulevard, Shahid Bahrami Street</address>
        <city>SARI</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4814956741</zip>
        <telephone>+98 11 3334 1592</telephone>
        <email>mgoli7098@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Soghra Khani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vesal Street, Amir Mazandarani Boulevard, Sari, Mazandaran Province, Iran</address>
        <city>SARI</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816715793</zip>
        <telephone>+98 11 3336 8918</telephone>
        <email>khanisog343@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>At least elementary education
Complete cessation of menstruation in the last 12 months without the use of medication or surgery
Having one wife for men
Living with a spouse
Couple participation in meetings with related content
No drug addiction
Declaration of written consent of the couple to participate in the study
Failure to participate in educational-counseling classes related to sexual performance before conducting the study
Age category 40 years and above</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Receiving effective counseling on sexual function by each couple during the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E28.3</hc_code>
      <hc_code>E29.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Primary ovarian failure</hc_keyword>
      <hc_keyword>Testicular hypofunction</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: Intervention sessions with the presence of couples will be conducted after completing the pre-test for 60 minutes and during 7 sessions with an interval of one week. People will be contacted once or twice a week to ensure that they complete their assignments. Immediately after the completion of the post-test intervention sessions and the follow-up and re-evaluation of the two groups in terms of sexual function (evaluation of the effectiveness of the treatment, couples' satisfaction with the results, handling of new or ongoing concerns) it will be 2 months later.</i_keyword>
      <i_keyword>Control group: In the control group, after the completion of the study, during a session, pamphlets containing educational materials about menopause care and the role of men and women in supporting each other during menopause will be provided to them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual function in postmenopausal women and men with andropause. Timepoint: Determining the sexual function of postmenopausal women and men with andropause before the intervention, after and two months after the intervention. Method of measurement: Female Sexual Function Index (FSFI), International Index of Erectile Function (IIEF), Androgen Deficiency in the Aging Male (ADAM), Male Andropause Symptoms Self-Assessment Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sexual satisfaction in postmenopausal women and men with andropause. Timepoint: Determining the sexual satisfaction of postmenopausal women and men with andropause before the intervention, after and 2 months after the intervention. Method of measurement: Larson's standard sexual satisfaction questionnaire (LSSQ).</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-17</approval_date>
        <contact_name>Ethics committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Moalem square, Moalem street Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
