<?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>IRCT20221218056861N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-18</date_registration>
      <primary_sponsor>Office of Research and Technology of Shahid Sadoughi University of Medical Sciences, Yazd, Iran</primary_sponsor>
      <public_title>Stress management skills training by 4A facilitation model and the mobile health self-help program in nursing students</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness comparison of stress management skills training by 4A facilitation model with the mobile health self-help program on clinical stress, self-efficacy, and professional identity of nursing students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67491</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Based on the inclusion criteria, using the online software (using the website www.random.org/sequences/), students are randomly assigned to two groups, the 4A facilitation model and the mobile health self-help program (45 people in each group). For random assignment, a code is given to each student between 1 and 90, and their random assignment is done based on the output of the mentioned software and after completing the informed consent by the participants. Again, each group is divided into five subgroups of 9 people by a simple random method. In this way, the study is conducted with the two main groups of the 4A facilitation model and the mobile health self-help program. The participants of group 4A are divided into 5 subgroups of 9 people. Participants will be told that there is a 50% chance of falling into each of these groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Clinical stress, self-efficacy and professional identity of students.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: implementation of the intervention in the 4A facilitation model group: after completing the questionnaires upon arrival (baseline), the people of this group will be offered five consecutive weeks of stress management skills training with the 4A model with the presence of a facilitator. During the training of this method, in the first step (asking), the student asks himself whether the stress he feels is a sign of distress caused by a clinical problem or is it a common annoyance? The purpose of this stage is to know the source of stress in nursing students. In the second stage (Affirmation), by sharing his feelings with others, the student is sure of the existence of stress and its cause, and initial efforts to manage and reduce it begin. In the third stage (Assess), the student identifies the source of discomfort and stress, which is personal or environmental, estimates the intensity of his stress and prepares himself for the action stage. In the last stage (act), the student tries to reduce stress both personally and professionally and uses strategies to achieve this goal. It is not uncommon for a person to go back to previous stages. The important thing is that the person tries to maintain his individual integrity after entering the action stage. Daily follow-up by sending text messages to keep the participants active and continue to practice the skills learned in the classes from the beginning of the study until one month after the end of the fifth week (the end of the ninth week). Intervention 2: Control group: Control group: implementation of the intervention in the self-help health program group: in order to keep the control group active during the study, training with the same content for five weeks at the same time as group 4A classes, in the form of textual content, photos, videos or audio files in This group is at the discretion of the students. In addition to the presented content, a stress reduction software (usable on IOS and Android operating systems) is introduced to students. The software is installed on the student's mobile phone participating in this group. The description of how to use the software is explained step by step through a video file. The person is requested to complete all the information requested in the stress reduction software daily. Daily follow-up by sending text messages to keep the participants active and completing the software daily from the beginning of the study until one month after the end of the fifth week (the end of the ninth week).</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:
All data can be shared after de-identifying individuals.

When:
Data accessibility will start 6 months after publication of the results.

To whom:
The data will be accessible to researchers working in academic and scientific institutions as well as people working in the industry.

Conditions:
Regarding the need for data to perform meta-analysis, more data (if applicable) will be provided after communication with the responsible author and approval of the research team.

Where to obtain:
Via an email request to the principle investigator and corresponding author:
Dr. Fatemeh Bakhshi, Faculty member
Research Center for Nursing and Midwifery Care, Shahid Sadoughi
University of Medical Sciences, Yazd, Iran Safaeih, Buali St.,
Yazd 8916877443, Iran
Email addresses: fateme.bakhshii@gmail.com; f.bakhshi@ssu.ac.ir

How to obtain:
Ten days after receiving the email, data will be provided if approved by the research team

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Bakhshi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahnar square, central building of Shahid Sadougi University of Medical Sciences</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916978477</zip>
        <telephone>+98 35 3824 1751</telephone>
        <email>F.bakhshi@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Bakhshi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahnar square, central building of Shahid Sadougi University of Medical Sciences</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916978477</zip>
        <telephone>+98 35 3824 1751</telephone>
        <email>F.bakhshi@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
Internet accessibility during the research period
Having the physical and mental ability to complete the questionnaire
Passing at least two academic semesters and one internship unit</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Occurrence of stressful events (such as death of family members, marriage or divorce)
A history of neurological and mental diseases or acute mental problems during the last year
Using psychiatric drugs
Experiencing stressful event(s) at least 6 months before the study
Participation in stress management skills training workshops</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z73.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stress, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: implementation of the intervention in the 4A facilitation model group: after completing the questionnaires upon arrival (baseline), the people of this group will be offered five consecutive weeks of stress management skills training with the 4A model with the presence of a facilitator. During the training of this method, in the first step (asking), the student asks himself whether the stress he feels is a sign of distress caused by a clinical problem or is it a common annoyance? The purpose of this stage is to know the source of stress in nursing students. In the second stage (Affirmation), by sharing his feelings with others, the student is sure of the existence of stress and its cause, and initial efforts to manage and reduce it begin. In the third stage (Assess), the student identifies the source of discomfort and stress, which is personal or environmental, estimates the intensity of his stress and prepares himself for the action stage. In the last stage (act), the student tries to reduce stress both personally and professionally and uses strategies to achieve this goal. It is not uncommon for a person to go back to previous stages. The important thing is that the person tries to maintain his individual integrity after entering the action stage. Daily follow-up by sending text messages to keep the participants active and continue to practice the skills learned in the classes from the beginning of the study until one month after the end of the fifth week (the end of the ninth week).</i_keyword>
      <i_keyword>Control group: Control group: implementation of the intervention in the self-help health program group: in order to keep the control group active during the study, training with the same content for five weeks at the same time as group 4A classes, in the form of textual content, photos, videos or audio files in This group is at the discretion of the students. In addition to the presented content, a stress reduction software (usable on IOS and Android operating systems) is introduced to students. The software is installed on the student's mobile phone participating in this group. The description of how to use the software is explained step by step through a video file. The person is requested to complete all the information requested in the stress reduction software daily. Daily follow-up by sending text messages to keep the participants active and completing the software daily from the beginning of the study until one month after the end of the fifth week (the end of the ninth week).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The clinical stress score of the students in Ebel's Clinical Stress Questionnaire. Timepoint: Measuring the clinical stress score at baseline and at the end of the ninth week of the study. Method of measurement: Ebel's Clinical Stress Questionnaire (1991)                                                     Clinical stress questionnaire: The clinical stress questionnaire was created by Abell (1991) and has 25 Items. This questionnaire evaluates  problems related to people's mental pressure. A higher score indicates more problems or higher severity. Habibi (2013) mentioned the content validity of the questionnaire as appropriate and obtained the reliability using Cronbach's alpha method of 0.88.</prim_outcome>
      <prim_outcome>Professional identity score of students in Macleod Clark's professional identity questionnaire. Timepoint: Measuring the professional identity score at the baseline and at the end of the ninth week of the study. Method of measurement: Macleod Clark Professional Identity Questionnaire                                        Macleod Clark Professional Identity Questionnaire: This scale was developed based on the theory of social identity and includes 9 items under the subscales of professional dynamics, intra-group and professional communication, feeling of belonging to this profession and self-evaluation. The possible total score is between 9 and 54, which means the higher score, the higher the professional identity.  Bakhshi et al. (2020) evaluated the psychometric validation of the original version of the McLeod Clark Professional Identity Questionnaire (MCPIS).</prim_outcome>
      <prim_outcome>Self-efficacy score of students in the clinical self-efficacy questionnaire. Timepoint: Measuring the self-efficacy score at the baseline and at the end of the ninth week of the study. Method of measurement: Clinical Performance Self-Efficacy Scale: This scale was designed and psychometrically evaluated by Cheraghi et al (2010). In this questionnaire, self-efficacy means the judgment of nursing students in the ability to organize and administer nursing care independently and based on the nursing process in the bedside. The minimum and maximum total scores are 37 to 148 respectively.</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>Office of Research and Technology of Shahid Sadoughi University of Medical Sciences, Yazd, Iran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-11</approval_date>
        <contact_name>Research Ethics Committees of Reproductive Sciences Institute - Shahid Sadoughi University of Medica</contact_name>
        <contact_address>Safaiyeh, Bu Ali St., Yazd Infertility Research and Treatment Center Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
