<?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>IRCT20161126031117N17</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-11-12</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of integrative couple counseling on sexual desire discrepancy after delivery</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of midwife-led integrative couple counseling with routine care on sexual desire discrepancy in couples after their delivery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/79978</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, the samples are matched based on the duration of marriage, the number of births and breastfeeding, and the block method will be used for the random allocation of the samples. For this purpose, two blocks will be considered. Two possible blocks are TC and CT, where T is for the intervention group and C is for the control group. The numbers will be generated randomly (with the RANDBETWEEN command in Excel software and in domain 1 and 2) And according to the production values of one of the blocks (production number 1 for CT block , production number 2 for TC blocks) will be selected and samples will be allocated. The sampling method will be done in convenience method, Blinding description: The evaluation of the consequences will be done using the PORSLINE through the social networks Eitaa or WhatsApp. The researcher and the evaluator do not know the group to which the participant belongs when evaluating the outcome.</study_design>
      <phase>N/A</phase>
      <hc_freetext>sexual desire discrepancy of couples.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Counseling sessions with the presence of couples will be conducted for an average of 60 minutes and during 5 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 intervention sessions, there will be a post-test and a session to follow up and re-evaluate the two groups in terms of the couples' sexual desire discrepancy and sexual satisfaction, four weeks later. Intervention 2: Control group: Control group: In addition to receiving routine midwifery care, after completing the study, they will be provided with a pamphlet containing educational materials about  sexual desire discrepancy of couples and sexual satisfaction after delivery and solutions to improve it in a session.</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 1404

To whom:
All researchers and those interested in research

Conditions:
To conduct review and supplementary research and for the use of Therapists and counselors of couples' sexual disorders

Where to obtain:
In order to receive documents or data, the corresponding author can be reached by email at khanisog343@gmail.com and counseling student in midwifery at f.tousheh@gmail.com. If the article is published according to the journal address, you can refer to that journal.

How to obtain:
First, you should send an email to the responsible author of the article and make your request, and if the responsible author and the research team deem it appropriate, the documents and files will be provided in a short period of time.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Tousheh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamzehkala Square</address>
        <city>babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4731714576</zip>
        <telephone>+98 11 3234 1294</telephone>
        <email>f.tousheh@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>Vasal St, Amir Mazandarani Blvd</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>Declaration of written consent of both couples to participate in the study
Women of childbearing age
At least 10 weeks have passed after their delivery
Return of menstruation
Living with a spouse
Access to a smartphone (to complete the form and questionnaires in the Porsline)
Availability in Length of the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>54 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Other chronic physical diseases
Addiction
Pregnancy
Suffering from mental disorders (depression, anxiety and stress based on the DASS-21 questionnaire) or physical diseases that interfere with their daily functioning.
Consumption Psychiatric drugs
Participating in educational and counseling courses related to improving sexual function in the last 6 months
History of genital or pelvic surgeries (such as hysterectomy) that affect their sexual desire</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F52.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hypoactive sexual desire disorder</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: Counseling sessions with the presence of couples will be conducted for an average of 60 minutes and during 5 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 intervention sessions, there will be a post-test and a session to follow up and re-evaluate the two groups in terms of the couples' sexual desire discrepancy and sexual satisfaction, four weeks later.</i_keyword>
      <i_keyword>Control group: Control group: In addition to receiving routine midwifery care, after completing the study, they will be provided with a pamphlet containing educational materials about  sexual desire discrepancy of couples and sexual satisfaction after delivery and solutions to improve it in a session.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual desire discrepancy of couples. Timepoint: Determining the sexual desire discrepancy of couples before, immediately and 4 weeks after the intervention. Method of measurement: Using Halbert Sexual Desire Questionnaire, the sexual desire score of each couple will be calculated. The couple's desire discrepancy scores will be calculated as the difference between the couple's sexual desire scores in the Halbert questionnaire, after standardization. That is, men's Z score from women's Z score will be reduced. For the discrepancy to be significant, the absolute value of the Z score with a 95% confidence interval should be greater than 1.96.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sexual satisfaction. Timepoint: Determining the sexual satisfaction of couples before, immediately and 4 weeks after the intervention. Method of measurement: Larson's standard sexual 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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-10-01</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>
