<?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>IRCT20220310054250N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-15</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Emotion regulation skills training versus self-helper mood tracking software on female sexual modes, female sexual distress and husband’s sexual satisfaction in medical university students undergoing premenstrual dysphoric disorder</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness comparison of  two interventions emotion regulation skills training versus self-helper mood tracking software on female sexual modes, female sexual distress and husband’s sexual satisfaction in medical university students undergoing premenstrual dysphoric disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62440</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In parallel Randomized Clinical Trial, recruitment is made Shahid Sadoughi University student groups. 68 eligible women are given number from 1 to 68. Using random allocation software, women are randomly assigned to group 1, emotion regulation or group 2, using mood monitoring software, based on software output table. Each group of 34 women is then randomly divided into two subgroups 17 women. Blinding is not possible.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Premenstural Dysphoric Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  group 1 receives the intervention emotion regulation training in Skyroom and WhatsApp in one-hour sessions one day a week for eight weeks. Intervention 2: Intervention group: group 2 users of mood monitoring software are given explanations related to software installation by the therapist and are asked to, in addition to daily recording of mood, other related factors such as sleep quality, nutritional status, meditation, compassion, relaxation, communication Record with spouse, family and friends as well as favorite pastimes. In addition, a diary of the explanations for these emotions, the cause of their occurrence, and the behavioral responses to these emotions are recorded. They are asked to share mood monitoring software data with the therapist via WhatsApp once a week.</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>Tahmineh Farajkhoda</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bouali</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۹۱۶۸۷۷۴۴۳</zip>
        <telephone>+98 35 3824 1754</telephone>
        <email>farajkhoda_t@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tahmineh Farajkhoda</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bouali</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۹۱۶۸۷۷۴۴۳</zip>
        <telephone>+98 35 3824 1754</telephone>
        <email>farajkhoda_t@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Married female students of Shahid Sadoughi University of Medical Sciences aged 19-49
Desire to participate in the study
Having an Android or iOS smartphone
History of diagnosis and treatment of premenstrual dysphoric disorder based on the seven criteria of DSM5 and in at least two consecutive cycles according to the calendar of premenstrual syndrome and clinical interviews,  symptoms are still presence.
Having sex with  spouse until the end of the study
Negative sexual modes
Having sexual distress
Low spouse sexual satisfaction</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Pregnancy
Presence of sexual dysfunction disorder in first half of mensural cycle
Having systemic illness
Having sever mental disorder
Being alcohol or drug abuser
Simultaneously participation in other similar study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.31</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mood disorder due to known physiological condition with depressive features</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  group 1 receives the intervention emotion regulation training in Skyroom and WhatsApp in one-hour sessions one day a week for eight weeks.</i_keyword>
      <i_keyword>Intervention group: group 2 users of mood monitoring software are given explanations related to software installation by the therapist and are asked to, in addition to daily recording of mood, other related factors such as sleep quality, nutritional status, meditation, compassion, relaxation, communication Record with spouse, family and friends as well as favorite pastimes. In addition, a diary of the explanations for these emotions, the cause of their occurrence, and the behavioral responses to these emotions are recorded. They are asked to share mood monitoring software data with the therapist via WhatsApp once a week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Female sexual modes. Timepoint: Baseline, completion of intervention at week 8, follow-up at week 12 from baseline. Method of measurement: Female sexual modes questionnaire.</prim_outcome>
      <prim_outcome>Female sexual distress. Timepoint: Baseline, completion of intervention at week 8, follow-up at week 12 from baseline. Method of measurement: Female Sexual Distress Scale.</prim_outcome>
      <prim_outcome>Woman's opinion about her husband's sexual satisfaction. Timepoint: Baseline, completion of the intervention in week 8, follow-up of study completion in week 12 from baseline. Method of measurement: Visual Analogue Scale.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-02</approval_date>
        <contact_name>Research Ethics committee of Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Bahonar Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
