<?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>IRCT20240813062743N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-08-24</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of cognitive behavioral therapy on health promoting lifestyle in students with premenstrual syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The effect of cognitive behavioral therapy on health promoting lifestyle in students with premenstrual syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78524</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling in a non-probability way and by the method of randomly assigning the intervention of people and by the method of randomized permutation blocks with a random block size of 4 (using the table related to random permutations) with one-to-one allocation (18 to 4 blocks) ) is The randomization list will be prepared by the statistician. The intervention used in this research is allocated according to the randomized list by a person outside the study who is not aware of the research objectives and according to the corresponding codes in the closed envelopes, and any measure to hide the sequence until the interventions are determined is done.Allocation concealment and blinding According to the nature of this study, it is not possible to blind researchers and participants, but after randomization, the codes assigned to each of the participants are kept by an unknown person in order to hide the expertise, so neither the participants nor The researcher is not aware of the order of allocation until the start of the intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Premenstrual syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The first intervention group: cognitive behavioral counseling for 8 sessions and the duration of each session is 60 minutes.  group. Intervention 2: Control group: no intervention is done, only two sessions of cognitive behavioral counseling are done as a thank you.</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:
After conducting the research, the data file can be shared for all researchers and professors to access the main result and the second result after de-identifying people.

When:
After one year from the time of printing the results, it will be possible to access up to 10 years after the printing of the results.

To whom:
The ways are accessible to all people who need them.

Conditions:
Any condition or analysis that in any way causes this research to contribute to the progress of other research or to help other researchers in retrospective research or review articles.

Where to obtain:
azadehmoteaghi@gmail.com
Mobile phone number 00989161720249

How to obtain:
As soon as we know about the request of people to receive documents, we will send the documents via email or mobile phone number.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azadeh Moteraghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Farazmand Menzel, Azadegan Bridge, Vetri Square, Behbehan, Khuzestan</address>
        <city>Behbahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6361763559</zip>
        <telephone>+98 61 5283 6152</telephone>
        <email>moteraghi.a@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azadeh Moteraghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Farazmand Menzel, Azadegan Bridge, Vetri Square, Behbehan, Khuzestan</address>
        <city>Behbahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6361763559</zip>
        <telephone>+98 61 5283 6152</telephone>
        <email>moteraghi.a@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18-30 years
Single
Suffering from moderate and severe type of premenstrual syndrome
Having regular menstruation with intervals of 24-35 days
Obtaining a score of less than 156 from the health promoting lifestyle questionnaire</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The presence of mental stress in the last three months, such as the death of relatives
Surgery (Surgeries that require sedation during the recovery period and uterus and ovary surgery or operations that require chemotherapy or radiation therapy afterwards.)
Suffering from physical diseases
Abnormal bleeding
History of mental illness
Taking antidepressants
Taking hormonal drugs
Having regular sports activity
Any specific treatment for Premenstrual syndrome( PMS)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The first intervention group: cognitive behavioral counseling for 8 sessions and the duration of each session is 60 minutes.  group.</i_keyword>
      <i_keyword>Control group: no intervention is done, only two sessions of cognitive behavioral counseling are done as a thank you.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cognitive-behavioral counseling on reducing premenstrual syndrome by filling out the premenstrual syndrome questionnaire and reducing the behavioral, psychological and physical symptoms of this syndrome- and the effect of this counseling on lifestyle and changing dimensions and spiritual growth and self-fulfillment, responsibility in health, relationships between Individual, stress management, physical activity and nutrition by filling in the questionnaire of Walker et al. Timepoint: .   Before the start of the intervention, immediately after the start of the intervention, one month and two months after the intervention, the effect of cognitive behavioral counseling on the dimensions of premenstrual syndrome. Method of measurement: PSST premenstrual syndrome questionnaire [2]: This questionnaire has two parts and 19 questions, the first part contains 14 questions about mood-behavioral and physical symptoms, and the second part contains 5 questions about the effect of premenstrual symptoms on performance. It examines people's lives. In this questionnaire, 4 main criteria are mentioned for each question: not at all, mild, moderate and severe, which are scored based on a Likert scale from 0 to 3. For each question, 4 criteria were mentioned: not at all, mild, moderate and severe, which were graded from 0 to 3. In order to diagnose moderate or severe PMS, the following three conditions must be present together: 1- From options 1 to 4, at least one case should be moderate or severe, 2- In addition to the previous case, from options 1 to 14, at least 4 cases should be moderate or severe and 3- In the section on the impact of symptoms on life (the last 5 options), there should be a moderate or severe case. In order to diagnose PMDD, the following three conditions must be present together: 1- From options 1 to 4, at least one case should be severe. 2- In addition to In the previous case, from options 1 to 14, at least 4 cases should be moderate or severe, and 3- there should be a severe case in the impact of symptoms on life (last 5 options). In this study, moderate and severe cases are included in the study. Lifestyle questionnaire: this questionnaire has 52 questions and 6 dimensions of spiritual growth and self-actualization (11 questions, from questions 1 to 11), responsibility for health (13 questions, from questions 12 to 24), interpersonal relationships (8 questions, from questions 25 to 32), stress management (6 questions, from questions 33 to 38), sports and physical activities (7 questions, from questions 39 to 45) and nutrition (7 questions, from questions 46 to 52). In this questionnaire, usually 4 answers are considered for each question and a score is given to each answer. A score of 1, 2, 3, and 4 is given to each of the questions in the questionnaire, respectively, for the answers of never, sometimes, most of the time, and always. The minimum score is 52 and the maximum is 208. The lifestyle score can be divided into three levels: a score of less than 103 is a poor lifestyle, 104-155 is an average lifestyle, and a score of 156 and above is considered a good lifestyle.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-08-11</approval_date>
        <contact_name>Ethics Committee of Jundishapur Ahvaz University</contact_name>
        <contact_address>Farazmand Manzel, Azadegan Bridge, Vetri Square, Khuzestan, Behbahan Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
