<?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>IRCT20170114031930N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-11-28</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Communication Skills Education Program on Quality of Parent-Daughter Relationship and Coping with Menstrual Complaints Among Adolescent Girls</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Communication Skills Education Program on Quality of Parent-Daughter Relationship and Coping with Menstrual Complaints Among Adolescent Girls</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24994</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: The randomization method in this study is a binary random block.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Premenstrual syndrome. Condition 2: Dysmenorrhea.</hc_freetext>
      <i_freetext>Intervention 1: Control group: before the intervention, the control group will be given brochures containing information about the knowledge of psychological coping with premenstrual syndrome and dysmenorrhea. In the control group, their girls and their fathers receive n. Intervention 2: Intervention group: Before the intervention, the intervention group will be given brochures containing information about the knowledge of psychological coping with  Menstrual complaints. After completing the questionnaires, communication skills education .</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></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sahar Rekab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran Nursing and Midwifery Faculty, Rashid Yasemi St., Vali-e-Asr Ave., Vanak Square, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 4365 1000</telephone>
        <email>saharsepideh70@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.  Nahid Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran Nursing and Midwifery Faculty, Rashid Yasemi St., Vali-e-Asr Ave., Vanak Square, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 4365 1000</telephone>
        <email>akbari1420@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Single female students (15-18 years old) and their fathers
Diagnosis of premenstrual syndrome or dysmenorrhea in three cycles of menstruation
Having a regular menstrual cycle (the duration of bleeding in the menstrual cycle is 7-10 days with a 28-33 days interval between two menstrual cycles)
Fathers and daughters have not lived apart, nor have they been step father and daughter
Father and mother live together
Fathers and daughters have not used psychiatric medications for the last 6 months
Having no mother with depression
Not taking oral contraceptive pills for the last 6 months
No specific physical and mental illnesses in fathers and daughters
No severe life crises such as death and divorce in the last three months</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Immigration and lack of access to the samples
The occurrence of any chronic or severe mental or physical illness
The occurrence of any crisis in the individual life (occurrence of death in the first degree relatives, parents’ divorce or severe family disputes)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N94.3</hc_code>
      <hc_code>N94.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Premenstrual tension syndrome</hc_keyword>
      <hc_keyword>Primary dysmenorrhoea</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: before the intervention, the control group will be given brochures containing information about the knowledge of psychological coping with premenstrual syndrome and dysmenorrhea. In the control group, their girls and their fathers receive n</i_keyword>
      <i_keyword>Intervention group: Before the intervention, the intervention group will be given brochures containing information about the knowledge of psychological coping with  Menstrual complaints. After completing the questionnaires, communication skills education </i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Parent-child relationship quality. Timepoint: Before, immediately, four weeks, eight weeks after the intervention. Method of measurement: Parent-Child Relationship Scale Questionnaire (PCRS).</prim_outcome>
      <prim_outcome>Premenstrual syndrome. Timepoint: Before, immediately, four weeks, eight weeks after the intervention. Method of measurement: PSST Questionnaire and Pre-menstrual Coping measure (PMCM).</prim_outcome>
      <prim_outcome>Special communication skills training. Timepoint: Before, immediately, four weeks, eight weeks after the intervention. Method of measurement: Training to a one-day workshop is held in the form of a speech, role play, film, etc.</prim_outcome>
      <prim_outcome>Duration of bleeding. Timepoint: Before intervention. Method of measurement: Demographic questionnaire.</prim_outcome>
      <prim_outcome>The amount of menstrual bleeding. Timepoint: Before intervention. Method of measurement: Demographic questionnaire.</prim_outcome>
      <prim_outcome>Menstrual cycle duration. Timepoint: Before intervention. Method of measurement: Demographic questionnaire.</prim_outcome>
      <prim_outcome>Regular bleeding courses. Timepoint: Before intervention. Method of measurement: Demographic questionnaire.</prim_outcome>
      <prim_outcome>Pain during menstruation. Timepoint: Before intervention. Method of measurement: Demographic questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Parent-child relationship quality. Timepoint: Before, immediately, four weeks, eight weeks after the intervention. Method of measurement: Parent-Child Relationship Scale Questionnaire (PCRS).</sec_outcome>
      <sec_outcome>Premenstrual syndrome. Timepoint: Before, immediately, four weeks, eight weeks after the intervention. Method of measurement: PSST Questionnaire and Pre-menstrual Coping measure (PMCM).</sec_outcome>
      <sec_outcome>Dysmenorrhea. Timepoint: Before, immediately, four weeks, eight weeks after the intervention. Method of measurement: Demographic 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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-08-03</approval_date>
        <contact_name>"Ethics Committee of Iran University of Medical Sciences"</contact_name>
        <contact_address>Campus of Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
