<?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>IRCT2017021324469N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-03-08</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences, Vice chancellor for research</primary_sponsor>
      <public_title>Effectiveness of counseling pregnant women on quality of sexual life and sexual satisfaction couples in pregnancy</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of counseling pregnant women on the PLISSIT model on quality of sexual life and sexual satisfaction couples in pregnancy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>256</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20647</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: subjects were allocated to each group of intervention and control randomly by Table of random numbers.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Effectiveness of counseling pregnant women on quality of sexual life and sexual satisfaction couples in pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: Before intervention, Quality of sexual life (SQOL-F) and sexual satisfaction questionnaire(LSSQ) will be filled in by intervention group. two sessions (60 to 90 minutes) will be held by a midwife researcher based on PLISSIT model with one week gap. A Consultant starts her speech by asking some open question about sexual satisfaction. Then pregnant woman begins to speak. Therefore, consultant will be aware of her mistake thought, false belief, incomplete information and worries. In addition, using a few pictures will be helpful to explain anatomy and physiology of the reproductive system. A midwife provides consultation for all members of intervention group. Educational booklet will be given to the spouses of intervention group including anatomy and physiology of the reproductive system, and information and recommendation about pregnancy sex issues. Quality of sexual life and sexual satisfaction will be evaluated two and four weeks after intervention. Intervention 2: Routine care consultation will be provided for control group.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Najmeh Dehlari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad Faculty of Nursing and Midwifery, Ebne Sina St, Doktora Crossroads</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+95 5138477339</telephone>
        <email>dehlarin921@mums.ac.ir</email>
        <affiliation>School of Nursing and Midwifery</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Khadijeh Mirzaii Najmabad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad Faculty of Nursing and Midwifery, Ebne Sina St, Doktora Crossroads</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>00</telephone>
        <email>mirzaiikh@mums.ac.ir</email>
        <affiliation>School of Nursing and Midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria&#13;
 Pregnant woman:&#13;
giving a written consent; having literacy; Being Iranian and living in Mashhad; Being 18 to 35 years old; Be a planned pregnancy; Has an alive singleton pregnancy; Be the first, second, third or fourth pregnancy; Does not have medical history; Does not have obstetric complications during her pregnancy or high risk pregnancy; Has’nt sexual dissatisfaction during her pregnancy.&#13;
Inclusion criteria&#13;
husband&#13;
giving a written consent; having literacy; Being Iranian and living in Mashhad; Be a planned pregnancy for her spouse; Does not have medical history; Has’nt sexual dissatisfaction during her pregnancy.&#13;
Exclusion criteria at the beginning of the study&#13;
Pregnant woman:&#13;
Current Pregnancy is after infertility treatment; Tobacco smoking, drug user, alcohol consumption or psychoactive drug; Mental problem history; happening stressful events during the past 6 months; Has experienced abortion; Takes medicine affecting on mental health; Has sexually transmitted disease; Does have vaginal intercourse due to hit in pelvic area or penis deformity.&#13;
Exclusion criteria during the study&#13;
Pregnant woman:&#13;
Lack of tendency of pregnant woman to continue her cooperation; Incomplete questionnaires; Be admitted to the hospital due to problems related to pregnancy during the study; Occur stressful event during the study; Be inaccessible in the second and the fourth week after consultation; Questionnaire is not filled in by the spouse of the pregnant woman.&#13;
Exclusion criteria at the beginning of the study&#13;
Husband&#13;
Tobacco smoking, drug user, alcohol consumption or psychoactive drug; Mental problem history; happening stressful events during the past 6 months; Takes medicine affecting on mental health; Has sexually transmitted disease; Taking medications effecting sexual function; Does have vaginal intercourse due to hit in pelvic area or penis deformity.&#13;
Exclusion criteria during the study&#13;
Husband&#13;
Lack of tendency to continue his cooperation; Incomplete questionnaires; Occur stressful event during the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F52</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>sexual dysfunction, not caused by organic disorder or disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Before intervention, Quality of sexual life (SQOL-F) and sexual satisfaction questionnaire(LSSQ) will be filled in by intervention group. two sessions (60 to 90 minutes) will be held by a midwife researcher based on PLISSIT model with one week gap. A Consultant starts her speech by asking some open question about sexual satisfaction. Then pregnant woman begins to speak. Therefore, consultant will be aware of her mistake thought, false belief, incomplete information and worries. In addition, using a few pictures will be helpful to explain anatomy and physiology of the reproductive system. A midwife provides consultation for all members of intervention group. Educational booklet will be given to the spouses of intervention group including anatomy and physiology of the reproductive system, and information and recommendation about pregnancy sex issues. Quality of sexual life and sexual satisfaction will be evaluated two and four weeks after intervention.</i_keyword>
      <i_keyword>Routine care consultation will be provided for control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual satisfaction. Timepoint: Before the intervention and 2 and 4 weeks after begining of intervention. Method of measurement: Larson sexual satisfaction questionnaire (LSSQ).</prim_outcome>
      <prim_outcome>Quality of sexual life. Timepoint: Before the intervention and 2 and 4 weeks after begining of intervention. Method of measurement: Quality of sexual life questionnaire (SQOL).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Mashhad University of Medical Sciences, Vice chancellor for research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-05-17</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Mashhad University of Medical Sciences, Vice chancellor for research, Ghoraishy Building, University St Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
