<?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>IRCT20220620055229N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-14</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Investigating sexual counseling based on online problem solving on anxiety and sexual intimacy in women with recurrent pregnancy loss</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of sexual counseling based on online problem solving on anxiety and sexual intimacy in women with recurrent pregnancy loss</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64276</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The first-generation random allocation method was used to assign the eligible participants into two intervention and active control groups, each participant was given a number from 1 to 70.
Then, using the website http://www.randomization.com. participants were randomly assigned into two blocks of 35, C and D.  A person external to the study used a random lottery method to select each block as an intervention or active control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sexual dysfunction counseling.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For the intervention group, 8 training sessions will be held online using voice and the possibility of questions and answers with private chat on the internal messaging network of ITA based on the program developed by the second researcher and under the supervision of the first and third researchers. The content of the sessions Includes: explanations about the terms sexual anxiety, sexual intimacy, frequent abortion and problem solving approach, teaching logical problem solving and defining the problem clearly and objectively, setting achievable and realistic goals to solve the problem, learning functional ABCs, training Effective problem solving in real life is through combining emotions and logical thinking, choosing the best solution, evaluating and reviewing. At the beginning of each session, a summary of the previous sessions will be reviewed and the assigned tasks related to the previous session will be reviewed by the researcher. they turn Women are asked to participate in discussions and raise their questions. At the end of each session, a summary of the important topics discussed is presented and people's questions are answered, and women are asked to do their homework in the next sessions. Intervention 2: Control group: The control group will receive 8 sessions of problem solving advice in the form of pamphlets and the possibility of questions and answers by telephone. The content of the sessions includes explanations about the terms sexual anxiety, sexual intimacy, frequent abortion and problem solving approach, teaching logical problem solving and defining the problem clearly and objectively, setting achievable and realistic goals to solve the problem, learning functional ABCs, Teaching effective real-life problem solving through combining emotions and logical thinking, choosing the best solution, evaluating and revising.</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 personal data of participants can be shared after de-identification.

When:
After printing the results

To whom:
The data will be available for researchers working in academic and scientific institutions, and people working in the industry can apply to receive them.

Conditions:
Scientific use

Where to obtain:
mah-bokaie@yahoo.com

How to obtain:
One week after receiving the applicant's email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>mahshid bokaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd, Bu Ali Ave</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877443</zip>
        <telephone>+98 35 2438 5117</telephone>
        <email>mah-bokaie@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>mahshid bokaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd, Bu Ali Ave</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877443</zip>
        <telephone>+98 35 2438 5117</telephone>
        <email>mah-bokaie@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a history of at least two recurrent pregnancy loss
Women aged 18-45 years
Not having major stress such as divorce and death of relatives in the last 3 months
Having a Cellphone  and access to ITA's internal messenger network
Being Iranian</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Pregnancy
patient’s or her spouse’s affliction with serious psychological disorders such as severe depression and psychosis
consumption of any drug affecting sexual relations by the patient or her spouse (self-reported)
history of participating in sexual health education and counseling sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N96</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Recurrent pregnancy loss</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: For the intervention group, 8 training sessions will be held online using voice and the possibility of questions and answers with private chat on the internal messaging network of ITA based on the program developed by the second researcher and under the supervision of the first and third researchers. The content of the sessions Includes: explanations about the terms sexual anxiety, sexual intimacy, frequent abortion and problem solving approach, teaching logical problem solving and defining the problem clearly and objectively, setting achievable and realistic goals to solve the problem, learning functional ABCs, training Effective problem solving in real life is through combining emotions and logical thinking, choosing the best solution, evaluating and reviewing. At the beginning of each session, a summary of the previous sessions will be reviewed and the assigned tasks related to the previous session will be reviewed by the researcher. they turn Women are asked to participate in discussions and raise their questions. At the end of each session, a summary of the important topics discussed is presented and people's questions are answered, and women are asked to do their homework in the next sessions.</i_keyword>
      <i_keyword>Control group: The control group will receive 8 sessions of problem solving advice in the form of pamphlets and the possibility of questions and answers by telephone. The content of the sessions includes explanations about the terms sexual anxiety, sexual intimacy, frequent abortion and problem solving approach, teaching logical problem solving and defining the problem clearly and objectively, setting achievable and realistic goals to solve the problem, learning functional ABCs, Teaching effective real-life problem solving through combining emotions and logical thinking, choosing the best solution, evaluating and revising</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Change in mean sexual anxiety scores. Timepoint: Baseline, end of intervention in week 8 and end of intervention in week 12. Method of measurement: Sexual anxiety Index (Davis et al.).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Change in mean sexual intimacy scores. Timepoint: Baseline, end of intervention in week 8 and end of intervention in week 12. Method of measurement: Sexual Intimacy Index (Bagarouzi et al.).</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-24</approval_date>
        <contact_name>Research Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd</contact_name>
        <contact_address>Yazd, Bahnar Ave Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
