<?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>IRCT20190625044002N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-06</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Influence of the implementation of Leventhal self-regulation model on Illness perception and pain severity of primary dysmenorrhea</public_title>
      <acronym>Leventhal model study</acronym>
      <scientific_title>Influence of the implementation of Leventhal self-regulation model on Illness perception and pain severity of primary dysmenorrhea</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44363</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>N/A</phase>
      <hc_freetext>Primary dysmenorrhea.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Training based on Leventhal self-regulation model. Based on the Leventhal self-regulation model and based on the results obtained from subscales of questionnaires completed by girls, educational content will be provided. The number of sessions for the test group will be set at three sessions and each session lasts 60 to 90 minutes and for three consecutive weeks (one session per week) in groups of 8-10. In total, 12 groups (6 test and 6 control groups) will be formed and 18 training sessions will be held within 2 months at the school. Individual counseling sessions related to dysmenorrhea and common personal problems will be conducted as far as the researcher can. The first session: Based on the 5 dimensions of understanding the disease will be designed. The therapist will first assess the adolescent's understanding of the nature of menstrual distress. The study includes psychological symptoms related to menstrual distress such as anxiety, depression, and physical disorders such as fatigue, pain and weakness. It also examines adolescents' beliefs and hearings about the prevalence of menstrual distress and its complications (beliefs related to the identity of the disease). The next step in adolescents' understanding of the cause of the disease and one's beliefs about menstrual distress is to eliminate false beliefs (beliefs related to the cause of the disease). Then the duration of the illness and the adolescent's understanding of the duration of the illness will be examined (timetable). The next step deals with the distressing effects of menstruation on adolescent life (Consequences). Finally, the researcher examines the adolescent's perception of the efficacy of existing treatments to control and improve the severity of menstrual pain and relieve menstrual distress symptoms (treatment and improvement ideas). This session will use techniques of self-control, verbal encouragement, exercise-related stress reduction, feedback, and behavior assessment, use of successful illness experiences, and adolescents will be asked to practice these techniques. Pre-adolescent session tutorials will be asked to talk about their feelings and ambiguities about menstrual distress and their beliefs and knowledge will be challenged by the therapist. The training will be to change the misperceptions and the negative about the disease. They 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 and teens will be asked to practice these techniques. Third Session (Evaluation and Closing): Teens from the previous session will be notified of this closing session. Pre-session tutorials will be reviewed first, and then teens will be asked about the impact of new training and experiences. Problems and obstacles for each teenager will be explored, rehearsals of the previous session will be repeated, and their questions answered. Different methods will be used to increase the effectiveness of the training program. To achieve the content needed by adolescents in cognitive and psychological dimensions, a booklet will be used in addition to individual and face-to-face education. The content of this booklet is easy to understand for all teens. It is an attempt to increase understanding of the disease by providing simple illustrations with textual explanations. The educational content of this leaflet includes the identification and definition of menstrual distress, a brief explanation of misconceptions about menstrual cycles and activities authorized and unauthorized during this period, personal hygiene, physical activity and exercise, nutrition and stress control techniques and relaxation. will be. The qualitative content of this booklet will be reviewed by ten faculty members. At the end of three sessions, this leaflet will be given to the intervention group. In addition, if you have any further questions about the study or illness, the teen will be contacted. 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:
En 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>Somayeh Asgari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery, Qazvin university of Medical Science, Bahonar blvd.</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 Asgari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery, Qazvin university of Medical Science, Bahonar blvd.</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 old</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>19 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The presence of secondary dysmenorrhoea and its underlying causes
History of known mental illnesses
Substance abuse history (self-declaration)
Surgical history of women
Unwilling to participate in the study.
Being Married
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>N94.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Primary dysmenorrhea</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: Training based on Leventhal self-regulation model. Based on the Leventhal self-regulation model and based on the results obtained from subscales of questionnaires completed by girls, educational content will be provided. The number of sessions for the test group will be set at three sessions and each session lasts 60 to 90 minutes and for three consecutive weeks (one session per week) in groups of 8-10. In total, 12 groups (6 test and 6 control groups) will be formed and 18 training sessions will be held within 2 months at the school. Individual counseling sessions related to dysmenorrhea and common personal problems will be conducted as far as the researcher can. The first session: Based on the 5 dimensions of understanding the disease will be designed. The therapist will first assess the adolescent's understanding of the nature of menstrual distress. The study includes psychological symptoms related to menstrual distress such as anxiety, depression, and physical disorders such as fatigue, pain and weakness. It also examines adolescents' beliefs and hearings about the prevalence of menstrual distress and its complications (beliefs related to the identity of the disease). The next step in adolescents' understanding of the cause of the disease and one's beliefs about menstrual distress is to eliminate false beliefs (beliefs related to the cause of the disease). Then the duration of the illness and the adolescent's understanding of the duration of the illness will be examined (timetable). The next step deals with the distressing effects of menstruation on adolescent life (Consequences). Finally, the researcher examines the adolescent's perception of the efficacy of existing treatments to control and improve the severity of menstrual pain and relieve menstrual distress symptoms (treatment and improvement ideas). This session will use techniques of self-control, verbal encouragement, exercise-related stress reduction, feedback, and behavior assessment, use of successful illness experiences, and adolescents will be asked to practice these techniques. Pre-adolescent session tutorials will be asked to talk about their feelings and ambiguities about menstrual distress and their beliefs and knowledge will be challenged by the therapist. The training will be to change the misperceptions and the negative about the disease. They 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 and teens will be asked to practice these techniques. Third Session (Evaluation and Closing): Teens from the previous session will be notified of this closing session. Pre-session tutorials will be reviewed first, and then teens will be asked about the impact of new training and experiences. Problems and obstacles for each teenager will be explored, rehearsals of the previous session will be repeated, and their questions answered. Different methods will be used to increase the effectiveness of the training program. To achieve the content needed by adolescents in cognitive and psychological dimensions, a booklet will be used in addition to individual and face-to-face education. The content of this booklet is easy to understand for all teens. It is an attempt to increase understanding of the disease by providing simple illustrations with textual explanations. The educational content of this leaflet includes the identification and definition of menstrual distress, a brief explanation of misconceptions about menstrual cycles and activities authorized and unauthorized during this period, personal hygiene, physical activity and exercise, nutrition and stress control techniques and relaxation. will be. The qualitative content of this booklet will be reviewed by ten faculty members. At the end of three sessions, this leaflet will be given to the intervention group. In addition, if you have any further questions about the study or illness, the teen will be contacted</i_keyword>
      <i_keyword>Control group: no intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity of primary dysmenorrheal. Timepoint: Measurement of menstrual pain intensity one and two months before the intervention, one month and three months after the intervention. Method of measurement: Measurement of menstrual pain with visual analog scale for pain.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Illness Perception. Timepoint: Measurement of Illness Perception before the intervention, one month and three months after the intervention. Method of measurement: Illness Perception 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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-17</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 Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
