<?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>IRCT20170430033718N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-07</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Comparison the Effectiveness of counseling  based on  PLISSIT and BETTER models on sexual function and sexual self-disclosure of women after childbirth</public_title>
      <acronym></acronym>
      <scientific_title>Comparision the Effectiveness of Counseling  based on two models of PLISSIT and BETTER on Sexual function and Sexual self-disclosure of women after childbirth</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25932</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: subjects were allocated to each group of intervention and control randomly by Table of random numbers. First group will receive PLISSIT model and BETTER model will be implemented for the second group. Both groups will participate in two sessions. All enrolled subjects will be assessed for demographic characteristics, sexual function, sexual self-disclosure, stress, depression and anxiety, Randomization description: The initial selection of samples was a multistage cluster. From the five health centers of Mashhad, two comprehensive health services were selected randomly (centers number 1 and 3). Then, among the centers of health center number one, two centers (one in city and the other is the margin) through the lottery. For the health center number three, we also work the same way. Of the 4 centers selected (2 centers are in the margin area and 2 centers in the non-marginal area of ​​Mashhad) we select one health center by lottery, which collects 4 base stations. Of all 4 centers and 4 bases, 10 eligible samples are selected as unpredictable. In order to prevent the exchange of information,  Participants in centers and sub-bases receive counseling in two different ways.</study_design>
      <phase>N/A</phase>
      <hc_freetext>sexual function.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: First, the FSFI and DASS-21 questionnaires and the Hulbert sexual self-disclosure questionnaire are measured by the individuals and the sexual function, sexual self-disclosure, and the degree of anxiety, depression and stress.PLISSIT model (Permission, Limited Information, Specific Suggestions, Intensive Therapy):The subjects in this group will receive five 60-90 minute therapy sessions. Sessions 1, 2 are all adapted from the PLISSIT treatment model including four therapeutic stages. St1: Permission; client freely talks about her sexual concerns. Permission also is given to those non-problematic sexual behaviors which subject has already experienced. St2: Limited Information; therapist provides patient with limited information about the given problem. St3: Specific Suggestions; specific recommendations are offered enabling patient to manage her sexual problems. The fourth stage: Intensive Therapy; psycho-sexual therapy is performed by the researcher or Co-I psychiatrist. All subjects will be provided the two therapy sessions even if they might not need to receive intensive therapy. Researcher will be in contact with the subjects regularly to avoid missing follow up as well as addressing their concerns related to the therapy. Interventions for the subjects will be free of charge. One month after the last session, sexual self-disclosure and sexual function are re-measured. Intervention 2: Intervention group2: Intervention group1: First, the FSFI and DASS-21 questionnaires and the Hulbert sexual self-disclosure questionnaire are measured by the individuals and the sexual function, sexual self-disclosure, and the degree of anxiety, depression and stress. BETTER model(Bring up,Explain,Tell,Time,Educate,Record). The subjects in this group will receive five 60-90 minute therapy sessions. Sessions 1, 2 are all adapted from the BETTER treatment model including six therapeutic stages. St1: Bring up; In the first step, the counselor simply speaks to the client about sexual issues and tells them that he can talk quite comfortable. In fact, this step is to give the client a chance to talk about sexual issues and identify her attitudes. St2: Explain; The consultant explains the importance and impact of sexual issues on quality of life, and also tells the reader that it is completely free to talk about this. It helps to normalize sexual discourse and reduce feelings of shame.St3: TELL; The consultant assures the client that she will provide all his information to solve her problem. St4:Time; The counseling time is determined on the basis of the patient's preference. Since rebuilding sex is a continuous process, the counselor should be available to address the concerns and respond to the patient's questions. St5: Educate; The counselor will educate the patient about the complications of childbirth, the effects of childbirth and lactation on sexual matters, so that her concerns go away. The counselor must be familiar with the client's knowledge of how to deal with sexual problems in order to correct misconceptions about proximity to delivery. St6: Record; Assessments, interventions and therapeutic outcomes are recorded. In order to prevent samples from falling and respond to their health problems, the researcher will frequently contact with the individuals during the visits. At the end one month after the last session, the degree of sexual self-confidence and performance score Sex is measured again.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farzaneh karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad Nursing and Midwifery Faculty, Doktora Crossroads, Avicenna Street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3605 0971</telephone>
        <email>Karimifr941@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rahele Babazadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad Nursing and Midwifery Faculty, Doktora Crossroads, Avicenna Street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3605 0971</telephone>
        <email>BabazadehR@mums.ac.ir</email>
        <affiliation>Mashhad 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>
    </countries>
    <criteria>
      <inclusion_criteria>Giving a written consent
Having literacy
Being iranian and living in Mashhad
Having a single child in recent pregnancy
Age 20 t0 45 years
Married and having an intact marriage
Participate in study from 4 week to 6 months after delivery
Having sex after delivery
Score 28 or less than 28 in FSFI questionnaire
Do not have chronic medical history that affect on sexual function
Term pregnancy</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Alcohol and other form of drug abuse
Severe mental disorder
Participate in sexual educational sessions outside the study enviroment
Taking medications that affect sexual function in woman or her husband
Prostatic and sexual dysfunction in husband
postpartum complications in recent delivery
History of surgical procedures or pelvic radiotherapy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F52.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: First, the FSFI and DASS-21 questionnaires and the Hulbert sexual self-disclosure questionnaire are measured by the individuals and the sexual function, sexual self-disclosure, and the degree of anxiety, depression and stress.PLISSIT model (Permission, Limited Information, Specific Suggestions, Intensive Therapy):The subjects in this group will receive five 60-90 minute therapy sessions. Sessions 1, 2 are all adapted from the PLISSIT treatment model including four therapeutic stages. St1: Permission; client freely talks about her sexual concerns. Permission also is given to those non-problematic sexual behaviors which subject has already experienced. St2: Limited Information; therapist provides patient with limited information about the given problem. St3: Specific Suggestions; specific recommendations are offered enabling patient to manage her sexual problems. The fourth stage: Intensive Therapy; psycho-sexual therapy is performed by the researcher or Co-I psychiatrist. All subjects will be provided the two therapy sessions even if they might not need to receive intensive therapy. Researcher will be in contact with the subjects regularly to avoid missing follow up as well as addressing their concerns related to the therapy. Interventions for the subjects will be free of charge. One month after the last session, sexual self-disclosure and sexual function are re-measured.</i_keyword>
      <i_keyword>Intervention group2: Intervention group1: First, the FSFI and DASS-21 questionnaires and the Hulbert sexual self-disclosure questionnaire are measured by the individuals and the sexual function, sexual self-disclosure, and the degree of anxiety, depression and stress. BETTER model(Bring up,Explain,Tell,Time,Educate,Record). The subjects in this group will receive five 60-90 minute therapy sessions. Sessions 1, 2 are all adapted from the BETTER treatment model including six therapeutic stages. St1: Bring up; In the first step, the counselor simply speaks to the client about sexual issues and tells them that he can talk quite comfortable. In fact, this step is to give the client a chance to talk about sexual issues and identify her attitudes. St2: Explain; The consultant explains the importance and impact of sexual issues on quality of life, and also tells the reader that it is completely free to talk about this. It helps to normalize sexual discourse and reduce feelings of shame.St3: TELL; The consultant assures the client that she will provide all his information to solve her problem. St4:Time; The counseling time is determined on the basis of the patient's preference. Since rebuilding sex is a continuous process, the counselor should be available to address the concerns and respond to the patient's questions. St5: Educate; The counselor will educate the patient about the complications of childbirth, the effects of childbirth and lactation on sexual matters, so that her concerns go away. The counselor must be familiar with the client's knowledge of how to deal with sexual problems in order to correct misconceptions about proximity to delivery. St6: Record; Assessments, interventions and therapeutic outcomes are recorded. In order to prevent samples from falling and respond to their health problems, the researcher will frequently contact with the individuals during the visits. At the end one month after the last session, the degree of sexual self-confidence and performance score Sex is measured again.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual Function. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: female sexual function index.</prim_outcome>
      <prim_outcome>Sexual self-disclosure. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Hurlbert Sexual Self-disclosure questionnaire.</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</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-02</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 Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
