<?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>IRCT20150608022609N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-04</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of peer education on premenstrual syndrome</public_title>
      <acronym></acronym>
      <scientific_title>A Comparison between the Effects of School-based Education Programs provided by Peer Group versus Health Practitioners on Premenstrual Syndrome in Adolescents</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19476</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: 1- from purposefully selected high schools in Iran’s educational system 2- Randomization at school level (using a random number table) and Allocated to peer-group education (IG1), health practitioner group education (IG2) and comparison group (CG). 3- Random selection of the eligible students in each group based on the required sample size, n=30, (using the built-in random number generator in Microsoft Excel).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Premenstrual syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group (1): Training of peer educators: At first, ten eligible volunteer students will be selected as potential peer educators to educate their peers. They will educate about life skills (include problem-solving, critical thinking, effective communication skills, decision-making, creative thinking, interpersonal relationship skills, self-awareness building skills, empathy, and coping with stress and emotions), puberty, menarche, physiology of menstruation, PMS, and its management (such as dietary changes and the use of aerobic exercise) by PI during six face-to-face 60-minutes sessions, in 3 weeks (twice a week). In the following, six of them who are qualified from school staff as well as PI's point of view will be select as peer educators to implement the intervention. The PI is a Master of Science degree student in midwifery and counseling.  Peer group education: Participants in this group (IG1, n=30, three subgroups with ten members) educated by two peer educators in each subgroup in six-60-minutes sessions for 3 weeks (twice a week) which will be supervised by the PI. The sessions will be in form of online in WhatsApp application and include: voice records, audio PowerPoint, short video clips, educational pamphlets, and at the end of every session, sometime will be dedicated to question and answer. The content of sessions will include issues like puberty, menarche and menstrual cycles, PMS, and its management. Intervention 2: Intervention Group (2): Health practitioner education: Simultaneously with the peer group education, participants in IG2 (n=30) will be educated by a health practitioner in six-60-minutes sessions for 3 weeks (twice a week). The content and delivery route of each session will be similar in two intervention groups. Intervention 3: Comparison group: The CG (n=30), as well as IGs, will receive school routine education provided by school counselors. In the Iranian educational system, in each school, a counselor position has been defined that she usually answers students' questions in many different areas as well as menstrual concerns.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data and effects are shared after being unidentifiable and ethical.

When:
Starting the access period from 2020

To whom:
Researchers working in academia and academia

Conditions:
Analysis and modification of data and other documentation is not permitted

Where to obtain:
Farzaneh Babapour
f.bbp1991@gmail.com

How to obtain:
Send the email and complete introduction and request the requested file

Adaptation to the terms of submission by the Dedicated Information Engine

Posting if matching

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farzaneh Babapour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 61, Babapour Alley, Alinejad St., Asgari Mohammadian Boulevard, Railway Square</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4814785138</zip>
        <telephone>+98 11 3332 5205</telephone>
        <email>f.bbp1991@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zohre Shahhosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasibeh School of Nursing and Midwifery, Vesal St., Amir Mazandarani Blvd.</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3397148157</zip>
        <telephone>+98 11 3379 5555</telephone>
        <email>z.shahhosseini@yahoo.com</email>
        <affiliation>Mazandaran 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>single
satisfaction of students and their parents attending the study,
, regular period of menstruation from 21 to 35 days
moderate to severe PMS according to the Premenstrual Syndrome Screening Tool (PSST)
not a professional athlete</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>18 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>use of therapies due to PMS, at baseline and during the study
hormonal or psychiatric drug intake affecting PMS, at baseline and during the study
diagnosis of a chronic disease
occurrence of unfortunate/stressful events for adolescents or their family in the last six months and during the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N94.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Premenstrual tension syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group (1): Training of peer educators: At first, ten eligible volunteer students will be selected as potential peer educators to educate their peers. They will educate about life skills (include problem-solving, critical thinking, effective communication skills, decision-making, creative thinking, interpersonal relationship skills, self-awareness building skills, empathy, and coping with stress and emotions), puberty, menarche, physiology of menstruation, PMS, and its management (such as dietary changes and the use of aerobic exercise) by PI during six face-to-face 60-minutes sessions, in 3 weeks (twice a week). In the following, six of them who are qualified from school staff as well as PI's point of view will be select as peer educators to implement the intervention. The PI is a Master of Science degree student in midwifery and counseling.  Peer group education: Participants in this group (IG1, n=30, three subgroups with ten members) educated by two peer educators in each subgroup in six-60-minutes sessions for 3 weeks (twice a week) which will be supervised by the PI. The sessions will be in form of online in WhatsApp application and include: voice records, audio PowerPoint, short video clips, educational pamphlets, and at the end of every session, sometime will be dedicated to question and answer. The content of sessions will include issues like puberty, menarche and menstrual cycles, PMS, and its management.</i_keyword>
      <i_keyword>Intervention Group (2): Health practitioner education: Simultaneously with the peer group education, participants in IG2 (n=30) will be educated by a health practitioner in six-60-minutes sessions for 3 weeks (twice a week). The content and delivery route of each session will be similar in two intervention groups.</i_keyword>
      <i_keyword>Comparison group: The CG (n=30), as well as IGs, will receive school routine education provided by school counselors. In the Iranian educational system, in each school, a counselor position has been defined that she usually answers students' questions in many different areas as well as menstrual concerns.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of  premenstrual syndrome. Timepoint: Daily record of severity of premenstrual syndrome's problems within 2 consecutive months ( 2menstrual cycles)before intervention and within 2 consecutive months( 2menstrual cycles) after the end of the intervention. Method of measurement: Premenstrual Symptoms Screening Tool  (PSST) AND Daily Record of Severity of Problems Chart (DRSP).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Frequency of PMDD. Timepoint: At the baseline and after the intervention. Method of measurement: PSST questionnaire.</sec_outcome>
      <sec_outcome>General Health score. Timepoint: At the baseline and after the intervention. Method of measurement: General Health Questionnaire- 28 Items (GHQ-28).</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-23</approval_date>
        <contact_name>Ethics Committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Nasibeh School of Nursing and Midwifery, Vesal St., Amir Mazandarani Blvd., Sari, Mazandaran Province Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
