<?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>IRCT20190625044002N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-03</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of implementation of Leventhal self-regulation model on menstrual distress</public_title>
      <acronym>Leventhal model study</acronym>
      <scientific_title>Investigating the effect of implementation of Leventhal self-regulation model on menstrual distress among adolescent girls</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>74</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40573</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Because the presence of intervention and control group members in a school is likely to cause information leakage, random group assignment will be made. For this purpose, two schools will be randomly selected for intervention group and two schools will be randomly selected for control group.Random allocation will be done by simple random method using random number table.</study_design>
      <phase>3</phase>
      <hc_freetext>Menstural distress.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Learning based on the Leventhal self-regulation model.Based on the Leventhal coordinate model and the results obtained from the subscales of the questionnaires completed by the girls, educational content will be provided. The number of sessions for the test group will be three sessions and the duration of each session is 60 to 90 minutes. In the first session, after initial communication with the patient, questions will be asked about their understanding and understanding of the current disease and its consequences. The meeting is based on five dimensions of understanding the illness and the impact of understanding the disease on psychological outcomes. These dimensions will include the nature of the disease (symptoms related to illness such as fatigue, weakness), the cause of the disease, the duration or perception of the individual during the illness, the outcome and expected outcomes of the disease, the effectiveness of control, treatment and improvement of the disease. Interventions for understanding illness will include self-control techniques, verbal encouragement, goal-setting (eg, reducing stress with exercise), feedback, and evaluating behaviors, using successful people's experiences in the field. In the second session, after reviewing the patient's pre-session training, she will be asked to talk about her feelings and ambiguities. Training will be designed to change the negative and negative perceptions of the disease. Patients will be asked to ask the researcher if there is a question from the previous session. The final 30 minutes of stress and relaxation strategies will be taught for 30 minutes. Participants will be asked to practice these techniques. Third Session (Evaluation and Closure): The patient will be informed of the closure of the previous session. First, the training sessions are reviewed, and the patient will be asked about the impact of new training and experiences. Problems and obstacles for each patient will be reviewed, exercises for the previous session will be repeated, and participants' questions will be answered. At the end of the third session a booklet will be provided to the patient including issues such as disease identification and definition, personal hygiene, physical activity and exercise, a brief explanation of the misconceptions about menstruation developed by the researcher. Intervention 2: Control group: No intervention.</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:
Individual data will be published as an attachment in the article after being unidentifiable

When:
After completing the study and simultaneously publishing the results

To whom:
All researchers interested in the subject of research

Conditions:
Written request for reasons requiring the use of data to be sent to the author

Where to obtain:
Corresponding to the author

How to obtain:
one month

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Somaye Asgari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahonar blevard, Qazvin university of Medical Science, School of Nursing &amp; Midwifery</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419759811</zip>
        <telephone>+98 28 3333 6003</telephone>
        <email>s.asgari71@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>somaye</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahonar blevard, Qazvin university of Medical Science, School of Nursing &amp; Midwifery</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419759811</zip>
        <telephone>+98 28 3333 6003</telephone>
        <email>s.asgari71@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The resident of Qazvin
Have regular menstruation
Experience at least 2 years of menstruation
Severity of pain in menstruation 4 or more than 4
Enroll in high school
Ages 14 to 19 years</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>19 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The presence of secondary dysmenorrhoea and its underlying causes
2. History of known mental illnesses
Substance abuse history (self-declaration)
Surgical history of women
Being Married
Unwilling to participate in the study
. Mandatory drug use in the last 6 months
Not attending meetings (attendance at all meetings is obligatory)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N94</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain and other conditions associated with female genital organs and menstrual cycle</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Learning based on the Leventhal self-regulation model.Based on the Leventhal coordinate model and the results obtained from the subscales of the questionnaires completed by the girls, educational content will be provided. The number of sessions for the test group will be three sessions and the duration of each session is 60 to 90 minutes. In the first session, after initial communication with the patient, questions will be asked about their understanding and understanding of the current disease and its consequences. The meeting is based on five dimensions of understanding the illness and the impact of understanding the disease on psychological outcomes. These dimensions will include the nature of the disease (symptoms related to illness such as fatigue, weakness), the cause of the disease, the duration or perception of the individual during the illness, the outcome and expected outcomes of the disease, the effectiveness of control, treatment and improvement of the disease. Interventions for understanding illness will include self-control techniques, verbal encouragement, goal-setting (eg, reducing stress with exercise), feedback, and evaluating behaviors, using successful people's experiences in the field. In the second session, after reviewing the patient's pre-session training, she will be asked to talk about her feelings and ambiguities. Training will be designed to change the negative and negative perceptions of the disease. Patients will be asked to ask the researcher if there is a question from the previous session. The final 30 minutes of stress and relaxation strategies will be taught for 30 minutes. Participants will be asked to practice these techniques. Third Session (Evaluation and Closure): The patient will be informed of the closure of the previous session. First, the training sessions are reviewed, and the patient will be asked about the impact of new training and experiences. Problems and obstacles for each patient will be reviewed, exercises for the previous session will be repeated, and participants' questions will be answered. At the end of the third session a booklet will be provided to the patient including issues such as disease identification and definition, personal hygiene, physical activity and exercise, a brief explanation of the misconceptions about menstruation developed by the researcher.</i_keyword>
      <i_keyword>Control group: No intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Menstrual distress. Timepoint: Measurement of menstrual distress before intervention, one month and three months after intervention. Method of measurement: Moos menstrual distress 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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-26</approval_date>
        <contact_name>Ethics Committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Ghazvin, Shahid Bahonar Blvd. Ghazvin University of Medical Sciences قزوین Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
