<?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>IRCT20161230031662N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-21</date_registration>
      <primary_sponsor>Vice chancellor for research Alborz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of sexual counseling on sexual function in pregnant women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of virtual based cognitive-behavioral sexual counseling on sexual function, satisfaction and intimacy in pregnant women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55918</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Block randomization method is used in the present study. This will be done using a random block internet tool via http://www.sealedenvelope.com/simple-randomiser/v1/lists. Block size is determined 4 and allocation was done upon arranges of codes in the blocks.
Randomization will concealed in sequentially numbered, sealed, opaque envelopes. After producing randomization sequence, 80 opaque envelopes will be provided and each randomization sequence is recorded on a card, then placed in the envelope in order. To keep concealment, envelopes are numbered too. The envelope is sealed and placed in a box in order. At the beginning of the registration of participants, according to the order of entry of eligible participants to study, one of the envelopes will be opened and the assigned group of the participant will be determined.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Eight weekly 90-minute group sex counseling sessions with virtual content based on cognitive behavioral therapy. First, a group will be formed in one of the messaging systems and research samples will be added to it. The studied samples will be included in the Telegram group. The intervention group will then be divided into three groups to participate in Skyroom classes. A 90-minute session is held weekly for each group. The content of the sessions will be prepared by preparing educational PowerPoint, Weiss, and educational video according to the layout designed in the session table in cooperation with and under the supervision of supervisors and counselors who are sufficiently proficient in sexual issues and sexual cognitive-behavioral counseling. Practice and homework on the taught material will be given at the end of the sessions and in the next sessions the homework will be reviewed. The content of all meetings will be recorded and will be uploaded to the Telegram channel for future reviewed and study for absents. The questions and problems of the samples will be answered individually by the researcher. Depending on the content of each session, text, audio, video or online classes will be used. Content of training sessions including: introduction and familiarity with treatment methods, anatomy and physiology, sexual cycle of men and women-Review and explanation of areas of sexual function and its changes during pregnancy, training and practice of emotions and behavior and training in relaxation, study of emotions, thoughts and sexuality dysfunctional behavior during pregnancy-cognitive errors,explaining the pattern of sexual changes during pregnancy, Practicing sexual fantasies-Rational alternatives, description of different position of intimacy during pregnancy, relaxation exercises and Kegel-exercises to change dysfunctional sexual thoughts, Definition of intimacy and its dimensions, Teaching how to establish intimacy, factors affecting sexual satisfaction and concentration, effective communication and greater participation-Review of teaching sexual relations techniques and answering questions. Intervention 2: Control group: 40 pregnant women just receive  routine prenatal 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:
Total potential data can be shared after unidentifiable people

When:
Data will be in access 6 months after publishing the results

To whom:
Only for researchers working in academic and scientific institutions

Conditions:
Scientific studies

Where to obtain:
Using Email Address: marmarmzf@gmail.com

How to obtain:
Up to a week after sending the email address

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Manizheh Fathalian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Medicine, University of Medical Sciences Campus, University of Art, End of West Bou Ali Street, Nobovvat Square, Karaj</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149779453</zip>
        <telephone>+98 26 3419 7685</telephone>
        <email>mahtab.fathi358@gmail.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Razieh Lotfi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1st Golestan Street, South Eshteraki Boulevard, Baghestan, Karaj</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149779453</zip>
        <telephone>+98 912 765 5855</telephone>
        <email>Lotfi_razieh@yahoo.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Sexual function score less than 28
First pregnancy
Single pregnancy
Wanted pregnancy
Gestational age 16 to 24 weeks
Low risk pregnancy
Having access to a phone with Android operating system
Internet literacy
Age 18 to 35 years
No grief in the three months before the study
Living with a spouse</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>High risk pregnancies such as placenta previa, threatened miscarriage, gestational hypertension, gestational diabetes and high risk screening
Smoking and drinking alcohol
Use of drugs and drugs that affect sexual response
Sexual dysfunction in the spouse
Severe mental illness
Attend similar treatment sessions for the past six months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z70.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Counseling related to sexual attitude</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: Eight weekly 90-minute group sex counseling sessions with virtual content based on cognitive behavioral therapy. First, a group will be formed in one of the messaging systems and research samples will be added to it. The studied samples will be included in the Telegram group. The intervention group will then be divided into three groups to participate in Skyroom classes. A 90-minute session is held weekly for each group. The content of the sessions will be prepared by preparing educational PowerPoint, Weiss, and educational video according to the layout designed in the session table in cooperation with and under the supervision of supervisors and counselors who are sufficiently proficient in sexual issues and sexual cognitive-behavioral counseling. Practice and homework on the taught material will be given at the end of the sessions and in the next sessions the homework will be reviewed. The content of all meetings will be recorded and will be uploaded to the Telegram channel for future reviewed and study for absents. The questions and problems of the samples will be answered individually by the researcher. Depending on the content of each session, text, audio, video or online classes will be used. Content of training sessions including: introduction and familiarity with treatment methods, anatomy and physiology, sexual cycle of men and women-Review and explanation of areas of sexual function and its changes during pregnancy, training and practice of emotions and behavior and training in relaxation, study of emotions, thoughts and sexuality dysfunctional behavior during pregnancy-cognitive errors,explaining the pattern of sexual changes during pregnancy, Practicing sexual fantasies-Rational alternatives, description of different position of intimacy during pregnancy, relaxation exercises and Kegel-exercises to change dysfunctional sexual thoughts, Definition of intimacy and its dimensions, Teaching how to establish intimacy, factors affecting sexual satisfaction and concentration, effective communication and greater participation-Review of teaching sexual relations techniques and answering questions.</i_keyword>
      <i_keyword>Control group: 40 pregnant women just receive  routine prenatal care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual function score in Rosen's female sexual performance questionnaire. Timepoint: In two turns, before the study begins and four weeks after the end of intervention. Method of measurement: Rosen women's sexual function questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sexual satisfaction score in the Larson questionnaire. Timepoint: At the beginning of the study and four weeks the end of the study. Method of measurement: Larson sexual satisfaction questionnaire.</sec_outcome>
      <sec_outcome>Sexual intimacy score in the in the Botlani questionnaire. Timepoint: At the beginning of the study and four weeks after the end of the study. 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>Vice chancellor for research Alborz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-26</approval_date>
        <contact_name>Ethics Committee of Alborz university of medical sciences</contact_name>
        <contact_address>Alborz University of Medical Sciences, Shahrake Edari, North Taleghani, Azimieh, Karaj Karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
