<?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>IRCT20180310039024N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-27</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Faculty of Behavioral Sciences and Mental Health, IUMS</primary_sponsor>
      <public_title>The effectiveness of "mindfulness -based sexual relationship therapy" and "cognitive behavioral sex therapy" On disorder’s symptoms in women with orgasmic disorder</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of effectiveness of "mindfulness -based sexual relationship therapy" and "cognitive behavioral sex therapy" On disorder’s symptoms in women with orgasmic disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53167</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: 1.	Since the studies conducted on the mentioned objectives are scattered, by examining the above objectives, important information can be identified and information gaps can be clarified.2.	Considering that mindfulness-based treatment methods have recently been considered by researchers in various fields of physical and mental disorders, the design and implementation of this study can provide practical evidence on the effectiveness of these methods in treatment of orgasmic disorders in women.3.	In this study, a treatment package is presented in which the goal is to pay attention and focus on sexual intercourse processes. In this package, some of Mr. and Johnson's sex therapy methods as well as stress reduction exercises based on mindfulness will be used to increase the pleasure experience and orgasm experience.4.	In addition, it is important to note that the limited studies that have been published in this field have mainly focused on the role of mindfulness-based interventions in the treatment of sexual arousal and less attention has been paid to examining the impact of these intervention in treatment of orgasmic disorders in women.5.	On the other hand, the results of this study, along with suggesting the fields of future supplementary studies, can be a suggestion for comparing other factors such as cost-effectiveness and side effects of drugs in clinical decisions, Randomization description: after first educational session,  according to the simple random method, at the individuals level, by execution table, among all eligible individuals participants assign to  two groups (intervention group and  control group (25 people each group), Blinding description: While clients are not morally barred from receiving the necessary services and interventions, and it is explained that the evaluation of their interventions is a study, participants in the study will not know which group is the experimental group. Also, to fill in the outcome assessment forms and to analyze the data, all data based on blind codes are provided to the evaluator and analyst.</study_design>
      <phase>N/A</phase>
      <hc_freetext>female orgasmic disorder - Quality of Sexual Function.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: mindfulness -based sexual relationship therapy Mindfulness therapy is the ability to focus attention on the internal and external experiences that are taking place and help the person become more aware of the present and increase non-judgmental observation and subsequent Reduce auto responders. In the forthcoming intervention, this method is designed using the mindfulness-based stress reduction method and the Masters and Johnson sexual therapy method in order to increase attention and focus on the sexual intercourse process and increase the pleasure and quality of orgasm. This method consists of eight intervention sessions. Intervention 2: Control group: cognitive behavioral sex therapy                                                        It is one of the treatment methods for mental illnesses that tries to treat various problems from anxiety and depression to various personality disorders by relying on human mentality and behavior. In the field of treatment of sexual disorders, cognitive-behavioral interventions are used as a common and well-known model, the therapeutic consequences of which have been confirmed in several studies. This method consists of eight intervention sessions.</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 and findings of the study will be published in the form of reports, articles, presentations and lectures in accordance with the diversity of stakeholders and in accordance with the objectives of the study.

When:
After the end of the study around August 1400

To whom:
Research team and study supervisors

Conditions:
Other researchers, clinical therapists, counselors, and health-related field managers

Where to obtain:
Principle Investigator: atoofi.m@iums.ac.ir

How to obtain:
Send an email stating the reasons for requesting the use of the data

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehrdad Kazemzadeh Atoofi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1, Sattarkhan St., Mansouri Ave., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613111</zip>
        <telephone>+98 21 6655 1666</telephone>
        <email>atoofi.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehrdad Kazemzadeh Atoofi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1, Sattarkhan St., Mansouri Ave., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613111</zip>
        <telephone>+98 21 6655 1666</telephone>
        <email>atoofi.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>In this project, among the patients referred to family clinics, sex disorder clinics and university psychiatric clinics, 50 women are invited to do the research who meet the conditions for inclusion in the study as follows:                                                                      1- Be married.
2-The diagnosis of female orgasm disorder has been set for them) Criteria for diagnosing the opinion of experts in the field of sexual disorders.
3-Do not have physical disorders related to this disease with the approval of a gynecologist.
4-According to the findings of the SCL-4 questionnaire, the total score of the person is less than the disruptive cutting point .
5-in the last 2 months do not use psychedelics and alcohol.
6- Not during pregnancy and lactation.
7- According to the experts in the field of sexual disorders, there are no other sexual dysfunctions in couples.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>1-Reluctance to cooperate with the study at any stage of the project</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F52.31</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female orgasmic disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: mindfulness -based sexual relationship therapy Mindfulness therapy is the ability to focus attention on the internal and external experiences that are taking place and help the person become more aware of the present and increase non-judgmental observation and subsequent Reduce auto responders. In the forthcoming intervention, this method is designed using the mindfulness-based stress reduction method and the Masters and Johnson sexual therapy method in order to increase attention and focus on the sexual intercourse process and increase the pleasure and quality of orgasm. This method consists of eight intervention sessions.</i_keyword>
      <i_keyword>Control group: cognitive behavioral sex therapy                                                        It is one of the treatment methods for mental illnesses that tries to treat various problems from anxiety and depression to various personality disorders by relying on human mentality and behavior. In the field of treatment of sexual disorders, cognitive-behavioral interventions are used as a common and well-known model, the therapeutic consequences of which have been confirmed in several studies. This method consists of eight intervention sessions</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Orgasm disorder. Timepoint: before intervention, Immediately after the end of the treatment program and quarterly follow-up. Method of measurement: questionnaires.</prim_outcome>
      <prim_outcome>Sexual function. Timepoint: before intervention, Immediately after the end of the treatment program and quarterly follow-up. Method of measurement: questionnaires.</prim_outcome>
      <prim_outcome>Quality of orgasm experience. Timepoint: before intervention, Immediately after the end of the treatment program and quarterly follow-up. Method of measurement: questionnaires.</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, Faculty of Behavioral Sciences and Mental Health, IUMS</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-22</approval_date>
        <contact_name>Ethics committee of Iran University of MedicalIran University of Medical Sciences</contact_name>
        <contact_address>Tehran, Hemmat Highway next to Milad Tower, Research Deputy Headquarters Building Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
