<?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>IRCT20220413054521N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-03-02</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of anger management training program on aggression and social problem solving</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of anger management training program on aggression and social problem solving of nursing students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-04-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75508</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: In this combined study, education includes a workshop, individual counseling, and motivational text messages, Randomization description: Sampling will be conducted using an accessible and convenient method. After determining the sample size using the blocked permutation method, participants will be divided into two groups, intervention and control. To ensure proportional allocation in blocks and the number of interventions, 40 individuals will be assigned to the intervention and control groups using blocked permutation. For random allocation of samples into 5 blocks of 8, initially, a set of 8 cases or units is considered. Then, these 8 units are divided into 5 blocks with an equal number, so each block includes 8 samples from these units. Subsequently, the order of units in each block is determined randomly using permutation methods. By assigning units to blocks and their random permutation, we will ensure that the random effects of variable distributions are preserved in the study. The random allocation list will be generated using the Random Allocation software, Blinding description: In this study, one-way blinding is used and blinding will be done in relation to the statistical analyst.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: aggression. Condition 2: Social problem solving.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group: The intervention group in the anger management education program will participate in four sessions, each lasting 1.5 hours, with two group workshops per week. These workshops will cover self-control techniques and effective communication, decision-making, mindfulness, cognitive errors, and mental rehearsal. The education will be conducted by the researcher in collaboration with and under the supervision of the nursing psychology department professors. One week after completing the workshops, each participant will receive individual counseling sessions for four days, one session per week, aiming to address anger management issues and apply techniques, facilitated by a psychiatric nurse. One week after completing the individual counseling, motivational text messages aligned with the lessons will be sent daily by the researcher to the intervention group for ten days. Participants will complete the Buss and Perry Aggression Questionnaire and Social Problem-Solving Inventory immediately after the intervention and again four weeks later. Intervention 2: Control Group: Throughout the study, the control group will not receive any intervention. At the end of the study, they will attend one educational workshop session and receive the materials in pamphlet form.</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 Not specified.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Narjes Nick</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemeh School of Nursing and Midwifery, Namazi Square, Zand Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4249</telephone>
        <email>nikn@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Narjes Nick</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Namazi Square, Zand BLVD Fatemeh School of Nursing and Midwifery</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4249</telephone>
        <email>nikn@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>3rd and 4th semester nursing students of Shiraz University of Medical Sciences
Willingness to participate in the study
Completing the informed consent form</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suffering from psychological diseases
Participation in workshops or similar courses</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F60.3</hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Borderline personality disorder</hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group: The intervention group in the anger management education program will participate in four sessions, each lasting 1.5 hours, with two group workshops per week. These workshops will cover self-control techniques and effective communication, decision-making, mindfulness, cognitive errors, and mental rehearsal. The education will be conducted by the researcher in collaboration with and under the supervision of the nursing psychology department professors. One week after completing the workshops, each participant will receive individual counseling sessions for four days, one session per week, aiming to address anger management issues and apply techniques, facilitated by a psychiatric nurse. One week after completing the individual counseling, motivational text messages aligned with the lessons will be sent daily by the researcher to the intervention group for ten days. Participants will complete the Buss and Perry Aggression Questionnaire and Social Problem-Solving Inventory immediately after the intervention and again four weeks later.</i_keyword>
      <i_keyword>Control Group: Throughout the study, the control group will not receive any intervention. At the end of the study, they will attend one educational workshop session and receive the materials in pamphlet form.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Aggression: Changes in scores based on the "Buss and Perry Aggression Questionnaire". Timepoint: before the intervention, immediately after the intervention and four weeks after the end of the intervention. Method of measurement: "Bass and Perry Aggression" Questionnaire.</prim_outcome>
      <prim_outcome>Social Problem-Solving: Changes in scores based on the "Revised Social Problem-Solving Inventory (SPSI-R) Questionnaire". Timepoint: before the intervention, immediately after the intervention and four weeks after the end of the intervention. Method of measurement: Questionnaire "Revised Social Problem Solving by D'Zurilla et al.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-01-26</approval_date>
        <contact_name>Research Ethics Committee of Schools of Nursing and Midwifery, Management and Medical Information sc</contact_name>
        <contact_address>Shiraz - Namazi Square, entrance of Namazi Hospital, Hazrat Fatemeh College of Nursing and Midwifery Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
