<?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>IRCT20180904040952N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-26</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of educational methods of small groups and peers, with the participation of mothers on menstrual hygiene behaviors in school students</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of educational methods of small groups and peers, with the participation of mothers on menstrual hygiene behaviors in school students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35180</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Among the high schools in Mashhad, three schools are designated from one district, and each school is assigned to one of the three study groups through the lottery. In each school, two classes are selected at the age of 15-13, and all girls who meet the criteria for entering these classes are enrolled in the study. Then people in each group are randomly selected.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Menstrual health.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: In the peer group, a limited number of students are selected and they are explained in two 45-60 minutes sessions about menstrual hygiene (in the areas of personal hygiene, nutrition, physical activity, pain relief and psychological support), and each of them teach to a number of their classmates. For mothers, the training is done in two 2-hour sessions with the same educational content. The menstrual hygiene behaviors questionnaire is completed before the intervention and after the end of the first and second menstrual periods. Intervention 2: Intervention group2: Training small groups, four sessions of 45 to 60 minutes a week about menstrual hygiene (in the areas of personal hygiene, nutrition, physical activity, pain relief and  psychological support). The members are divided into groups of 3 to 4, In each session, individual, two to two study, a group discussion is done and eventually one will deliver the results of the discussion to the entire group. For mothers, the training is done in two 2-hour sessions with the same educational content. The menstrual hygiene behaviors questionnaire is completed before the intervention and after the end of the first and second menstrual periods. Intervention 3: Control group: In the control group, routine school education is done on menstrual menstrual hygiene (in the areas of personal hygiene, nutrition, physical activity, pain relief and  psychological support).</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 The release plan is still unknown.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reihaneh Jarrahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Daneshgah Ave, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>jarrahir951@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Golmakani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Daneshgah Ave, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>GolmakaniN@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranian and resident of Mashhad
A female student is in the 7th or 8th grade
The student and mother are interested in participating in the study and have written consent
Be single
Age of 15-13 years
Have a history of at least one menstruation
Regular menstrual cycles (within the range of 21 to 35 days)
Live with her mother.
The mother has literacy to read and write.
Have a phone number</inclusion_criteria>
      <agemin>13 years</agemin>
      <agemax>15 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Use of medicines affecting the psyche (three-ring anti-depressant drugs, monoamine oxidase inhibitors and benzodiazepines)
Over the past 6 months, she has experienced any disastrous or stressful incidents (deaths of first degree relatives, severe familial disorders, financial problems, major changes in living conditions, academic failure and probation, emotional problems)
Follow certain diets such as diets of obesity, weight loss, vegetarianism, water therapy.
Lack of physical health (a history of medical illness such as diabetes, thyroid disorders, Cushing's disease, pituitary tumors, genital diseases such as myoma, endometriosis, ovarian cysts, pelvic inflammatory disease).
She has already participated in menstrual hygiene education classes.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z00.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for examination for normal comparison and control in clinical research program</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: In the peer group, a limited number of students are selected and they are explained in two 45-60 minutes sessions about menstrual hygiene (in the areas of personal hygiene, nutrition, physical activity, pain relief and psychological support), and each of them teach to a number of their classmates. For mothers, the training is done in two 2-hour sessions with the same educational content. The menstrual hygiene behaviors questionnaire is completed before the intervention and after the end of the first and second menstrual periods.</i_keyword>
      <i_keyword>Intervention group2: Training small groups, four sessions of 45 to 60 minutes a week about menstrual hygiene (in the areas of personal hygiene, nutrition, physical activity, pain relief and  psychological support). The members are divided into groups of 3 to 4, In each session, individual, two to two study, a group discussion is done and eventually one will deliver the results of the discussion to the entire group. For mothers, the training is done in two 2-hour sessions with the same educational content. The menstrual hygiene behaviors questionnaire is completed before the intervention and after the end of the first and second menstrual periods.</i_keyword>
      <i_keyword>Control group: In the control group, routine school education is done on menstrual menstrual hygiene (in the areas of personal hygiene, nutrition, physical activity, pain relief and  psychological support)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Student's menstrual health behaviors. Timepoint: Before the onset of intervention, at the end of the first and second menstrual cycle. Method of measurement: Menstrual health behavior 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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-31</approval_date>
        <contact_name>The Ethics Committee of the Mashhad Medical Science University</contact_name>
        <contact_address>Mashhad, University Street, Quraishi Building Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
