<?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>IRCT20171008036651N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-11-01</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of electronic simulation-based training on non-suicidal self-harm</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of electronic simulation in the field of non-suicidal self-harm on the knowledge, attitudes and Clinical self-efficacy of nursing and emergency medical students: An interprofessional education</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Pending</recruitment_status>
      <url>https://irct.ir/trial/93157</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: In this study, three 30-minute educational videos including text, audio, video, and photos will be used to implement the intervention, as well as real scenarios and scenarios created with the help of artificial intelligence using AI-based tools in the form of talking avatars to increase the impact on students, Randomization description: In this study, stratified randomization will be used to assign participants to study groups. Eligible students—serving as the units of randomization—will first be categorized into separate strata based on their academic semester. Subsequently, participants within each stratum will be allocated to three groups (two intervention groups and one control group) using an equal allocation ratio (1:1:1).
To generate the random allocation sequence, a list of eligible individuals within each stratum will be compiled, and each participant will be assigned a unique numerical code. Then, using a draw-based method, a random sequence for assigning individuals to the three groups will be generated independently for each stratum.
To ensure allocation concealment, sequentially numbered, opaque, sealed envelopes will be used. Following the verification of inclusion criteria, obtaining informed consent, and completing the baseline assessment, the envelope corresponding to each participant will be opened in numerical order to reveal their assigned group. It should be noted that, given the nature of the educational intervention—where both students and researchers may become aware of the specific intervention—blinding of participants and researchers is not feasible; however, the data analyst will remain unaware of the group assignment codes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non-suicidal self-harm.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The educational intervention will be delivered using three 30-minute videos based on electronic simulation and using a variety of media including text, audio, video, and images. The educational content includes six main areas: (1) definition and differentiation of non-suicidal self-injury (NSSI), prevalence, age of onset, and epidemiological trends; (2) causes and motivations, risk and protective factors, and physical, psychological, and social outcomes; (3) influential psychological and social factors and the role of stigma and misbeliefs; (4) identification of signs and symptoms and assessment of NSSI; (5) educational and therapeutic interventions aimed at reducing self-injury; and (6) psychological support and referral principles. In order to increase educational effectiveness, real-life scenarios and scenarios generated with artificial intelligence-based tools in the form of talking avatars will be used. After completing the pre-test, the educational videos will be presented to the intervention groups in three face-to-face sessions over a week. Intervention 2: Control group: The control group will receive routine theoretical and clinical training during the intervention in the intervention groups. Post-test data will be collected online from all three groups immediately after the end of the last session and one month after the intervention. In line with the ethical principles of intervention research, educational videos will also be made available to control group participants after the completion of post-test data collection.</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 There is no additional information available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Yasaman Yaghobi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshjoo Street، Shahid Beheshti Highway</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4146939814</zip>
        <telephone>+98 13 3255 3202</telephone>
        <email>yasamanyaghobi@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yasaman Yaghobi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshjoo Street، Shahid Beheshti Highway</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4146939814</zip>
        <telephone>+98 13 3255 3202</telephone>
        <email>yasamanyaghobi@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
Currently pursuing an undergraduate degree in Nursing or Emergency Medical Services
Completion of at least one course unit in Psychiatric Nursing or Psychiatric and Behavioral Emergencies
No prior experience in providing training on self-harm, nor participation in related training courses</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Employment or a history of professional experience in psychiatric or psychiatric emergency settings
Presence of a physical, sensory, or cognitive limitation affecting the ability to use the electronic simulation platform</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>X78</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Intentional self-harm by sharp object</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 educational intervention will be delivered using three 30-minute videos based on electronic simulation and using a variety of media including text, audio, video, and images. The educational content includes six main areas: (1) definition and differentiation of non-suicidal self-injury (NSSI), prevalence, age of onset, and epidemiological trends; (2) causes and motivations, risk and protective factors, and physical, psychological, and social outcomes; (3) influential psychological and social factors and the role of stigma and misbeliefs; (4) identification of signs and symptoms and assessment of NSSI; (5) educational and therapeutic interventions aimed at reducing self-injury; and (6) psychological support and referral principles. In order to increase educational effectiveness, real-life scenarios and scenarios generated with artificial intelligence-based tools in the form of talking avatars will be used. After completing the pre-test, the educational videos will be presented to the intervention groups in three face-to-face sessions over a week.</i_keyword>
      <i_keyword>Control group: The control group will receive routine theoretical and clinical training during the intervention in the intervention groups. Post-test data will be collected online from all three groups immediately after the end of the last session and one month after the intervention. In line with the ethical principles of intervention research, educational videos will also be made available to control group participants after the completion of post-test data collection.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knowledge of nursing and emergency medical students regarding patients with non-suicidal self-harm. Timepoint: Before the intervention, immediately after the last video, and one month after the intervention. Method of measurement: Researcher-developed questionnaire on knowledge in the field of non-suicidal self-harm: This questionnaire will consist of 18 questions on a two-valued scale of true and false, and the possible score range will be between 0 and 18. Higher scores will indicate better knowledge in the field of NSSI.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Attitudes of nursing and emergency medicine students towards patients with non-suicidal self-harm. Timepoint: Before the intervention, immediately after the last video, and one month after the intervention. Method of measurement: Nurses' Attitudes Towards Patients with Non-Suicidal Self-Injury (NANSSI): This questionnaire consists of 22 questions across four dimensions, including negativity about outcomes of care, adoption of a consultative approach, violation of norms of care, and perceptions about self-injury, designed on a five-point Likert scale with a midpoint of "undecided" (from one: "strongly disagree" to five: "strongly agree"). In the final version of the scale, these items were 1, 3, 10, 18, 19, 20, 21, and 22. The range of possible scores was between 22 and 110. Higher scores indicated a more positive attitude toward patients with NSSI.</sec_outcome>
      <sec_outcome>Clinical Self-Efficacy of Nursing and Emergency Medical Services Students in Encountering Patients with Non-Suicidal Self-Injury. Timepoint: Before the intervention, immediately after the last video, and one month after the intervention. Method of measurement: Self-Efficacy in Dealing with Self-Harm Questionnaire (SEDSHQ): This questionnaire consists of 27 items across three dimensions—self-efficacy in personal skills, communication with the patient, and communication with the patient's support network (family and friends)—designed using a four-point Likert scale ranging from "probably no" to "definitely yes." The total score is calculated by summing the item scores and ranges from 27 to 108; a higher score indicates greater perceived self-efficacy in dealing with individuals who engage in self-harming behavior.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-08-19</approval_date>
        <contact_name>Research Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Opposite 17 Shahrivar Hospital، Siadati Street، Namjoo Street Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
