<?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>IRCT20180710040407N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-15</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of counseling based of PLISSIT model focused on sexual dysfunctional beliefs on sexual function and quality of sexual life of women with sexual dysfunction</public_title>
      <acronym></acronym>
      <scientific_title>The effect of counseling based of PLISSIT model focused on sexual dysfunctional beliefs on sexual function and quality of sexual life of women with sexual  dysfunction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33863</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: in the intervention group, counseling of dysfunctional sexual beliefs is based on a PLISSIT model by a researcher whose competence has been approved by the supervisor and counselor. Meetings are held in three individual sessions and a 60 minute group session with intervals of one week based on four stages of the PLISSIT model.control group receive routin care of health center, Randomization description: The method of allocating centers to intervention and control groups is simple in lottery form, Blinding description: Data analysis is performed by a statistician who is unaware of the allocation of individuals to groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>sexual dysfunction.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group will receive three individual counseling sessions (60 minutes) weekly and a group counseling session (90minutes) based on on four stages of the PLISSIT model focused on sexual dysfunctional beliefs. Intervention 2: The control group will provided with routine services by the staff in healthcare centers.</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:
The results of this study will be provided to the library of the Faculty of Nursing and Midwifery of Mashhad for the use of students and research units as well as enthusiasts as the senior dissertation on midwifery. A copy of this study was also made available to relevant authorities upon request.
Publication of the results in prestigious scientific and research journals will be done in compliance with the authors' rights in all publications resulting from this research project.

When:
Probably from the Mehr 1398

To whom:
Researchers, students and research units as well as other enthusiasts

Conditions:
The use of thesis in articles or any scientific article is subject to the mention of the source and in accordance with the publication regulations of Mashhad University of Medical Sciences.

Where to obtain:
Library of the School of Nursing and Midwifery of Mashhad

How to obtain:
Contact e-mail with supervisor and registered author

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Malihe Mohammadzadeh Moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Crossroad of the Doktora - School of Nursing and Midwifery-</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>mohammadzadehmm3@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery - Crossroad of the doktora - mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>MoradiM@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranian and resident of Mashhad.
At the age of fertility and above 18 years old.
Having sex during the last month.
The woman is living with her husband.
First marriage
Having sexual dysfunction according to the FSFI scale
Having at least one dysfunctional sexual belief according to the SDBQ questionnaire</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having depression, stress, or anxiety, according to the DASS-21 scale.
Having a medical or mental illness that could have an effect on sexual function
Using a drug that could have an effect on sexual function.
Has taken part in an educational or counseling course.
Having burdensome or severe incidents in the last 6 months.
being in pregnancy or lactation period (having child younger than two years old).
Existence of mental or physical disability in a woman or spouse.
Having infertility.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F52.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other sexual dysfunction not due to a substance or known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group will receive three individual counseling sessions (60 minutes) weekly and a group counseling session (90minutes) based on on four stages of the PLISSIT model focused on sexual dysfunctional beliefs.</i_keyword>
      <i_keyword>The control group will provided with routine services by the staff in healthcare centers.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual function. Timepoint: The beginning of the study and after the consultation sessions and one month after the consultation sessions. Method of measurement: The Female Sexual Function Index (FSFI).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of sexual life. Timepoint: The beginning of the study and after the consultation sessions and one month after the consultation sessions. Method of measurement: The sexual quality of life-female questionnaire (SQOL-F).</sec_outcome>
      <sec_outcome>Sexual function. Timepoint: The beginning of the study and after the consultation sessions and one. Method of measurement: FSFI 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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-18</approval_date>
        <contact_name>Ethics committee of the Mashhad University of Medical Sciences</contact_name>
        <contact_address>opposite to University Street 18 .University Street - Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
