<?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>IRCT2015100324322N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-07-08</date_registration>
      <primary_sponsor>Research Committee, Ahvaz Jundishapur University of Medical Sciences,  Ahvaz, Iran</primary_sponsor>
      <public_title>Efficacy of Cognitive Behavior Therapy on Sexual function and satisfaction among post-menopausal women</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of Cognitive Behavior Therapy on Sexual function and satisfaction among post-menopausal women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>4</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20553</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Menopause sexual dysfunction.</hc_freetext>
      <i_freetext>Single case( multiple baseline), intervention will be held 8 sessions of 90 minutes according to researcher-made protocol based on cognitive behavioral therapy for every four participants held weekly..</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary>           Efficacy of Cognitive Behavior Therapy on Sexual function and satisfaction among post-menopausal women&lt;br /&gt;&#13;
Abstract&lt;br /&gt;&#13;
Background and aim: Menopause is one of the factors that can affect sexual function. Many postmenopausal women suffer from sexual dysfunction at this time. The purpose of the present study was the impact of Cognitive Behavior Therapy on sexual function and satisfaction of post-menopausal women. &lt;br /&gt;&#13;
Methods: This study was a single-case design (multiple baselines) according to the cognitive behavior therapy. The study samples were 4 post-menopausal women aged 45 to 65. To gather the data a demographic questionnaire, Female Sexual Function Index (FSFI) and Index of Sexual Satisfaction (ISS) were used. Cognitive behavior therapy was administered for 8 weeks, with one session per week. In order to follow up, all women re-evaluated two months after treatment, every 20 days.&lt;br /&gt;&#13;
Results: The result of this study demonstrated that the score of desire, sexual arousal, vaginal moisture, orgasm and sexual function and satisfaction increased significantly in women in the interventional program. Also the score of pain decreased significantly (except for participant No 3). These results were the same at the end of study and after follow-up. &lt;br /&gt;&#13;
Conclusion: Based on the findings of the present study, that cognitive behavioral therapy is an effective program to improve sexual function and satisfaction, among postmenopausal women.&lt;br /&gt;&#13;
Key Words: menopause, Cognitive Behavior Therapy, sexual function, sexual satisfaction&lt;br /&gt;&#13;
</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>Hajar Haghighi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 611336754360</telephone>
        <email>haghighi.h@ajums.ac.ir; negar8606@yahoo.com</email>
        <affiliation>Ahwaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Parvin Abedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61 3373 8331</telephone>
        <email>parvinabedi@ymail.com</email>
        <affiliation>School of Nursing &amp; Midwifery, Ahvaz Jundishapur University  of Medical Sciences, Ahvaz, Iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: menopausal women aged between 45- 60 year old (at least one year after amenorrea);  married with stable life with her husband; first married; natural menopause; monogamy;  FSFI&lt;26;  ISS&lt;75; minimum education: diploma and accessible for 6 months. &#13;
Exclusion criteria: not having sex during the study; vaginal/ cervical/ pelvic infection( by examination); diagnosed psychological illness; history of sexual abuse or sexual harassment; addiction ( alcohol, drugs and other psychotropic drugs); occurrence of mishap events ( death, accidents with disabilities, treason, etc.) during the last 6 months; chronic diseases affect sexuality for menopausal women or her husband such as diabetes, cardiovascular disease, hypertension, cancer, vascular damage caused by accidents, thyroid disorders, spinal disorders, parkinson's disease, MS; the use of hormone replacement therapy (HRT) or topical estrogen for last 6 months.</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N95.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified menopausal and perimenopausal disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Single case( multiple baseline), intervention will be held 8 sessions of 90 minutes according to researcher-made protocol based on cognitive behavioral therapy for every four participants held weekly.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Menopausal sexual function. Timepoint: Before intervention, during intervention, two months after intervention. Method of measurement: Female sexual function index (FSFI).</prim_outcome>
      <prim_outcome>Menopausal sexual satisfaction. Timepoint: Before intervention, during intervention, two months after intervention. Method of measurement: Female sexual function index (FSFI).</prim_outcome>
      <prim_outcome>Menopausal sexual distress. Timepoint: Before intervention, during intervention, two months after intervention. Method of measurement: Female sexual function index (FSFI).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sexual desire in menopausal wemon. Timepoint: Before intervention, during intervention, two months after intervention. Method of measurement: Female Sexual Function Index.</sec_outcome>
      <sec_outcome>Sexual arousal in menopausal wemon. Timepoint: Before intervention, during intervention, two months after intervention. Method of measurement: Female Sexual Function Index.</sec_outcome>
      <sec_outcome>Sexual lubrication in menopausal wemon. Timepoint: Before intervention, during intervention, two months after intervention. Method of measurement: Female Sexual Function Index.</sec_outcome>
      <sec_outcome>Orgasm  in menopausal wemon. Timepoint: Before intervention, during intervention, two months after intervention. Method of measurement: Female Sexual Function Index.</sec_outcome>
      <sec_outcome>Sexual satisfaction in menopausal wemon. Timepoint: Before intervention, during intervention, two months after intervention. Method of measurement: Female Sexual Function Index.</sec_outcome>
      <sec_outcome>Sexual pain in menopausal wemon. Timepoint: Before intervention, during intervention, two months after intervention. Method of measurement: Female Sexual Function Index.</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>Research Committee, Ahvaz Jundishapur University of Medical Sciences,  Ahvaz, Iran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-06-20</approval_date>
        <contact_name>Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran</contact_name>
        <contact_address>Ahvaz- Golestan Blvd Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
