<?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>IRCT20170607034381N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-05-24</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>The impact of counseling on the performance and intimacy of pregnant women.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of counseling with the good enoughsex model (GES) on sexual function and sexual intimacy of pregnant women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/83039</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After determining the sequences, individuals will be selected using a simple random method and assigned to two groups using block randomization with a block size of 4. The procedure is as follows: the group assignments, based on the generated sequence, will be placed in sealed envelopes, and the envelopes will be numbered. For each individual, according to their order of entry into the study, the corresponding numbered envelope will be opened, and they will be assigned to one of the groups without the participant being aware.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Sexual dysfunction. Condition 2: Sexual intimacy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Implementing the first three dimensions of the GES model and explaining the importance of sexual activity; teaching the definition of sexual satisfaction and function, and the factors affecting it; describing the four stages of the sexual response cycle; explaining the impact of pregnancy on sexual function and its mechanism; correcting misconceptions and superstitions about sexual intercourse and creating an optimistic attitude; reviewing previous learning and summarizing the previous session; and implementing dimensions four, five, and six of the GES model; teaching healthy nutrition and performing Kegel exercises; teaching mindfulness skills and concentration exercises, and a three-minute breathing exercise; providing a timed table for noting the individual's thoughts and mindset during pleasant sexual experiences, unpleasant experiences, aversion, pain, and muscle contractions in the body; teaching how to enjoy each other; implementing the seventh, eighth, and ninth dimensions of the GES model; considering the problems and concerns noted by clients during the previous weeks; counseling for physical adaptation to anatomical changes; helping to maintain verbal and emotional connection with the spouse and emphasizing the importance of foreplay and lovemaking between couples; describing and examining the pattern of sexual changes and potential physical problems during pregnancy and focusing on the fivefold goal in orgasm; identifying five principles for sexual intercourse; accepting multiple intentions from both parties; avoiding unilateral and inflexible goals and clarifying the sexual agenda; describing different coital positions and styles of sexual stimulation; combining styles and creating variety in the relationship. Implementing the tenth, eleventh, and twelfth dimensions of the GES model; counseling and education about the physical and psychological differences between men and women in each stage of the sexual cycle; teaching communication skills; teaching skills for creating and maintaining intimacy. Intervention 2: Control group: Routine pregnancy care.</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:
All data is potentially shareable after unidentifiable individuals

When:
12 months after the results are published

To whom:
Researchers working in scientific and academic institutions

Conditions:
En According to the terms and conditions of Shahroud Medical Sciences University, the data can be used

Where to obtain:
Fateme Mohtadi fatememohtadi713@gmail.com

How to obtain:
Written request and consent of the Executor of the project and colleagues

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Mohtadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hafte Tir Square</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>36147-73943</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>Fatememohtadi713@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Mohtadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hafte Tir Square</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>36147-73943</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>fmohtadii21@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>First pregnancy
Informed consent
Low-risk pregnancy
Presence of spouse
Literacy</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F52</hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sexual dysfunction not due to a substance or known physiological condition</hc_keyword>
      <hc_keyword></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: Implementing the first three dimensions of the GES model and explaining the importance of sexual activity; teaching the definition of sexual satisfaction and function, and the factors affecting it; describing the four stages of the sexual response cycle; explaining the impact of pregnancy on sexual function and its mechanism; correcting misconceptions and superstitions about sexual intercourse and creating an optimistic attitude; reviewing previous learning and summarizing the previous session; and implementing dimensions four, five, and six of the GES model; teaching healthy nutrition and performing Kegel exercises; teaching mindfulness skills and concentration exercises, and a three-minute breathing exercise; providing a timed table for noting the individual's thoughts and mindset during pleasant sexual experiences, unpleasant experiences, aversion, pain, and muscle contractions in the body; teaching how to enjoy each other; implementing the seventh, eighth, and ninth dimensions of the GES model; considering the problems and concerns noted by clients during the previous weeks; counseling for physical adaptation to anatomical changes; helping to maintain verbal and emotional connection with the spouse and emphasizing the importance of foreplay and lovemaking between couples; describing and examining the pattern of sexual changes and potential physical problems during pregnancy and focusing on the fivefold goal in orgasm; identifying five principles for sexual intercourse; accepting multiple intentions from both parties; avoiding unilateral and inflexible goals and clarifying the sexual agenda; describing different coital positions and styles of sexual stimulation; combining styles and creating variety in the relationship. Implementing the tenth, eleventh, and twelfth dimensions of the GES model; counseling and education about the physical and psychological differences between men and women in each stage of the sexual cycle; teaching communication skills; teaching skills for creating and maintaining intimacy.</i_keyword>
      <i_keyword>Control group: Routine pregnancy care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual Function. Timepoint: Before the intervention, immediately after the intervention, one month after the intervention. Method of measurement: Rosen Sexual Function Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sexual Intimacy. Timepoint: Before the intervention, immediately after the intervention, one month after the intervention. Method of measurement: Botlani Sexual Intimacy 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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-04-13</approval_date>
        <contact_name>Research Ethics Committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>Hafte Tir Square Shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
