<?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>IRCT2014110119779N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-05-25</date_registration>
      <primary_sponsor>Vice chancellor for research, Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>effects of teaching sexual health counseling on midwifery students’ clinical skill in providing sexual health counseling</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effects of Standardized Patient and workshop methods of teaching on midwifery students’ clinical skill in providing sexual health counseling</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-10-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>62</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17605</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Other design features: Randomization was performed by using the table of random numbers.</study_design>
      <phase>N/A</phase>
      <hc_freetext>sexual health counseling.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1: In standardized patient-based group, the educational content include definition and fundamentals of sexual health counseling, sexual history taking, normal intercourse, sexual activity during pregnancy, breast feeding and menopause and sexual disorders that were delivered using lecture, slide show and questions and answers in the first day. On the second day the students were divided into five small groups. Education was performed with 5 standard patients with different complains that played five different scenarios. In each small group, students practiced the sexual history taking, diagnosis and treatment for one of standardized patients for 30 minutes. Then all groups joint in a large group and in each session that lasted for nearly 50 minutes, a student from each group, took a sexual history from a SP that previously practiced in small group and presented her diagnosis and treatment plan and answered to the students' questions in this regard. Ultimately researchers presented the required complementary explanation about the SP's complaint and summarized the discussion. Intervention 2: Intervention 2: In workshop group, the educational content and teaching methods were similar to the standardized patient group on the first day. On the second day students were divided into six small groups and each group had 5 times of small group discussion. In each time, they studied a case and discussed about it in 30 minutes. The cases were similar to scenarios of standardized patient of previous group. After each session of discussion about the cases, the small groups joint together and during the next 30 minutes, one of the students presented the results of their group discussion and answered to the students' questions in this regard. Ultimately researchers presented the complementary explanation about each case and answered the students' questions.</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>Mina Ardaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Ibn-Sina Avenue, Crossroads Doktora, Daneshgah Avenue, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3852 8513</telephone>
        <email>Ardaghim911@mums.ac.ir; minaardaghi@gmail.com; mina_ardaghi@yahoo.com</email>
        <affiliation>Faculty of Nursing and Midwifery of Mashhad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Talat Khadivzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Ibn-Sina Avenue, Crossroads Doktora, Daneshgah Avenue, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3852 8513</telephone>
        <email>KhadivzadehT@mums.ac.ir</email>
        <affiliation>Faculty of nursing and midwifery of Mashhad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: undergraduate and postgraduate midwifery students, passing sexual disorders theory, consent to participate in research.&#13;
 Exclusion criteria: the absence in one of educational sessions or course examinations.</inclusion_criteria>
      <agemin>21 years</agemin>
      <agemax>41 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z70.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other sex counselling</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 1: In standardized patient-based group, the educational content include definition and fundamentals of sexual health counseling, sexual history taking, normal intercourse, sexual activity during pregnancy, breast feeding and menopause and sexual disorders that were delivered using lecture, slide show and questions and answers in the first day. On the second day the students were divided into five small groups. Education was performed with 5 standard patients with different complains that played five different scenarios. In each small group, students practiced the sexual history taking, diagnosis and treatment for one of standardized patients for 30 minutes. Then all groups joint in a large group and in each session that lasted for nearly 50 minutes, a student from each group, took a sexual history from a SP that previously practiced in small group and presented her diagnosis and treatment plan and answered to the students' questions in this regard. Ultimately researchers presented the required complementary explanation about the SP's complaint and summarized the discussion.</i_keyword>
      <i_keyword>Intervention 2: In workshop group, the educational content and teaching methods were similar to the standardized patient group on the first day. On the second day students were divided into six small groups and each group had 5 times of small group discussion. In each time, they studied a case and discussed about it in 30 minutes. The cases were similar to scenarios of standardized patient of previous group. After each session of discussion about the cases, the small groups joint together and during the next 30 minutes, one of the students presented the results of their group discussion and answered to the students' questions in this regard. Ultimately researchers presented the complementary explanation about each case and answered the students' questions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Students’ clinical skill in providing sexual health counseling. Timepoint: Once before the intervention and again two weeks after the intervention. Method of measurement: According to step by step checklist.</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>Vice chancellor for research, Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-07-12</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Central Organization of Mashhad University of Medical Sciences, Daneshgah Avenue, Mashhad mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
