<?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>IRCT2014070318338N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-08-03</date_registration>
      <primary_sponsor>Vice Chancellor for research, Kashan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of cognitive-behavioral therapy and treatment with sildenafil on sexual function and marital satisfaction in women</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of cognitive-behavioral therapy and treatment with sildenafil in the treatment of arousal and orgasm disorders, sexual satisfaction and marital satisfaction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>86</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16657</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>female sexual dysfunction.</hc_freetext>
      <i_freetext>Intervention 1: Treatment with 50 mg sildenafil orally one hour before intercourse. Intervention 2: Cognitive-behavioral therapy weekly for 8 sessions was conducted by a female therapist with a PhD in clinical psychology according to the following protocol: from the first to the third session: Introduction, general understanding of different types of sexual disorders and their effect on marital quality, explaining the value and importance of its treatment, determining the main problem, evaluating the method of intercourse, communication skills training, provide sex education and sexual knowledge, identifying irrational thoughts and beliefs and correct assertiveness training/ from the fourth to the sixth session: Cognitive restructuring and changing negative attitudes toward sexual issues, type one sensory concentration, type two sensory concentration, training Kegel exercises, using educational tools, penetration without orgasm, relaxation techniques to minimize everyday-life anxiety/ the seventh and the eighth sessions: the turning point maneuver, intercourse and orgasm, problem solving skills training and its application in everyday-life to minimize the distressing situations, summing up the points made during therapy sessions, elucidating the likelihood of recurrence of symptoms after treatment and responding correctly at the time of symptoms recurrence.</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>Dr.Fatemeh Mehrzad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Psychiatry Group, Kargarnejad Hospital, Ghotbe Ravandi Blvd.</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 5554 0036</telephone>
        <email>Fateme_mehrzad@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Fatemeh Mehrzad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Psychiatry Group, Kargarnejad Hospital, Ghotbe Ravandi Blvd.</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 5554 0036</telephone>
        <email>Fateme_mehrzad@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Being in a monogamous relationship with only one guy for at least 6 months prior to participation in the study; The presence of sexual functioning disorders diagnosed by a psychiatrist. Exclusion criteria: symptomatic heart diseases; untreated psychiatric disorders; spinal cord injuries; uncontrolled diabetes mellitus; history of drug abuse; alcohol use; stroke during at least the six previous months; heart attack  during at least the six previous months; physical problems of female reproductive tract diagnosed by the gynecologist; those who do not have the willingness to have sex due to familial conflicts</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F52.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>other sexual dysfunction, not caused by organic disorder or disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Treatment with 50 mg sildenafil orally one hour before intercourse</i_keyword>
      <i_keyword>Cognitive-behavioral therapy weekly for 8 sessions was conducted by a female therapist with a PhD in clinical psychology according to the following protocol: from the first to the third session: Introduction, general understanding of different types of sexual disorders and their effect on marital quality, explaining the value and importance of its treatment, determining the main problem, evaluating the method of intercourse, communication skills training, provide sex education and sexual knowledge, identifying irrational thoughts and beliefs and correct assertiveness training/ from the fourth to the sixth session: Cognitive restructuring and changing negative attitudes toward sexual issues, type one sensory concentration, type two sensory concentration, training Kegel exercises, using educational tools, penetration without orgasm, relaxation techniques to minimize everyday-life anxiety/ the seventh and the eighth sessions: the turning point maneuver, intercourse and orgasm, problem solving skills training and its application in everyday-life to minimize the distressing situations, summing up the points made during therapy sessions, elucidating the likelihood of recurrence of symptoms after treatment and responding correctly at the time of symptoms recurrence</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual desire. Timepoint: before the intervention/4weeks after the intervention/8weeks after the intervention/12weeks after the intervention(end of intervention). Method of measurement: FSFI standardized questionnaire.</prim_outcome>
      <prim_outcome>Sexual excitment. Timepoint: before the intervention/4weeks after the intervention/8weeks after the intervention/12weeks after the intervention(end of intervention). Method of measurement: FSFI standardized questionnaire.</prim_outcome>
      <prim_outcome>Vaginal lubrication. Timepoint: before the intervention/4weeks after the intervention/8weeks after the intervention/12weeks after the intervention(end of intervention). Method of measurement: FSFI standardized questionnaire.</prim_outcome>
      <prim_outcome>Orgasm. Timepoint: before the intervention/4weeks after the intervention/8weeks after the intervention/12weeks after the intervention(end of intervention). Method of measurement: FSFI standardized questionnaire.</prim_outcome>
      <prim_outcome>Sexual satisfaction. Timepoint: before the intervention/4weeks after the intervention/8weeks after the intervention/12weeks after the intervention(end of intervention). Method of measurement: FSFI standardized questionnaire.</prim_outcome>
      <prim_outcome>Dysparonia. Timepoint: before the intervention/4weeks after the intervention/8weeks after the intervention/12weeks after the intervention(end of intervention). Method of measurement: FSFI standardized 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>Vice Chancellor for research, Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-10-26</approval_date>
        <contact_name>Kashan University of Medical Sciences ethics committee</contact_name>
        <contact_address>Vice chancellor for research, Kashan Medical Sciences complex, Ghotbe Ravandi Blvd., Kashan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
