<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04416074</url>
  </required_header>
  <id_info>
    <org_study_id>5-week Identity intervention</org_study_id>
    <nct_id>NCT04416074</nct_id>
  </id_info>
  <brief_title>An Online 5-week Professional Identity Group Psychotherapy</brief_title>
  <official_title>An Online 5-week Professional Identity Group Psychotherapy for Nursing Student During Clinical Rotation Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central South University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Central South University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an online 5-week group psychological intervention for the nursing students during&#xD;
      clinical rotation practice. It aims at promoting the professional identity and career&#xD;
      sefl-efficacy for them.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Those 110 participants come from two classes in the same grade. One will be randomly&#xD;
      allocated as the intervention group, the other will be control group. The intervention will&#xD;
      be delivered via an online meeting software, like Zoom. The control group will received five&#xD;
      messages fo self care messages forward by the researcher.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 10, 2020</start_date>
  <completion_date type="Actual">June 20, 2020</completion_date>
  <primary_completion_date type="Actual">June 13, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Professional identity</measure>
    <time_frame>We will measure the score of professional identity before intervention and immediately after intervention.</time_frame>
    <description>Professional identity in recent one week measured by Chinese Profession identity scale for nursing student, ranging from 17 to 85, with higher score reflects higher level of idnetity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Career self-efficacy</measure>
    <time_frame>We will measure the score of career self-efficacy before intervention and immediately after intervention.</time_frame>
    <description>Career self-efficacy in recent one week measured by the Chinese career self-efficacy scale for nursing student, ranging from 27-135, with higher score reflects higher level of career self-efficacy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stress</measure>
    <time_frame>We will measure the score of stress before intervention and immediately after intervention.</time_frame>
    <description>A reflection of one's perceived stress in recent month measured by the subscale from the Depression, Anxiety, and Stress Scale (DASS-21). The score rangs from 0-21, with higher score reflects higher level of stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resilience</measure>
    <time_frame>We will measure the score of resilience before intervention and immediately after intervention.</time_frame>
    <description>Resilience in recent one week measured by the Chinese version of Connor-Davidson Resilience Scale-10. The score ranges from 0-40, with higher score reflects higher level of resilience.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>General rating</measure>
    <time_frame>We will measure this immediately after intervention.</time_frame>
    <description>Several descriptive question to gather the feedback of the intervention. Each question will be rated from 0 to 5, with higher score reflects higher level of satisfaction.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Identification (Psychology)</condition>
  <arm_group>
    <arm_group_label>Group psychotherapy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Students will be intervened by an online 5-week professional identity group psychotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controlled message push group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Students will receive online messages of self-care knowledge forward by researchers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>An online 5-week professional identity group psychotherapy</intervention_name>
    <description>This is an online 5-week group psychological intervention for the nursing students during clinical rotation practice. It aims at promoting the professional identity and career sefl-efficacy for them. There are five sessions in the intervention, and each session lasts from 60min to 90min at each week. The intervention will be delivered via an online meeting software, like Zoom. There will be 15-20 students in one meeting group.</description>
    <arm_group_label>Group psychotherapy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Message push</intervention_name>
    <description>Controlled group will receive online messages of self-care knowledge forward by researchers once per week. The knowledge contain stress regulation, strategies for relaxation, self-protection during clinical practice.</description>
    <arm_group_label>Controlled message push group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Full time nursing student&#xD;
&#xD;
          -  During clinical rotation practice&#xD;
&#xD;
          -  Able to comprehend the intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Visual impairment&#xD;
&#xD;
          -  Absent more than twice of the intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anni Wang, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>School of Nursing, Fudan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School of Nursing, Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>20023</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Ohlen J, Segesten K. The professional identity of the nurse: concept analysis and development. J Adv Nurs. 1998 Oct;28(4):720-7. doi: 10.1046/j.1365-2648.1998.00704.x.</citation>
    <PMID>9829659</PMID>
  </reference>
  <reference>
    <citation>Kirpal, S.J.C.D.I., Work identities of nurses: Between caring and efficiency demands. 2004.</citation>
  </reference>
  <reference>
    <citation>Roberts SJ. Development of a positive professional identity: liberating oneself from the oppressor within. ANS Adv Nurs Sci. 2000 Jun;22(4):71-82. doi: 10.1097/00012272-200006000-00007.</citation>
    <PMID>10852670</PMID>
  </reference>
  <reference>
    <citation>Megginson LA. RN-BSN education: 21st century barriers and incentives. J Nurs Manag. 2008 Jan;16(1):47-55. doi: 10.1111/j.1365-2934.2007.00784.x.</citation>
    <PMID>18211335</PMID>
  </reference>
  <reference>
    <citation>Cook TH, Gilmer MJ, Bess CJ. Beginning students' definitions of nursing: an inductive framework of professional identity. J Nurs Educ. 2003 Jul;42(7):311-7. doi: 10.3928/0148-4834-20030701-08.</citation>
    <PMID>12873061</PMID>
  </reference>
  <reference>
    <citation>Hunter B, Segrott J. Re-mapping client journeys and professional identities: a review of the literature on clinical pathways. Int J Nurs Stud. 2008 Apr;45(4):608-25. doi: 10.1016/j.ijnurstu.2007.04.001. Epub 2007 May 23.</citation>
    <PMID>17524406</PMID>
  </reference>
  <reference>
    <citation>Yamagishi M, Kobayashi T, Nakamura Y. Effects of web-based career identity training for stress management among Japanese nurses: a randomized control trial. J Occup Health. 2008;50(2):191-3. doi: 10.1539/joh.l7086. No abstract available.</citation>
    <PMID>18403870</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Anni Wang</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Professional identity</keyword>
  <keyword>Career self-efficacy</keyword>
  <keyword>Resilience</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The participants are not willing to share the data.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 3, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT04416074/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04416074
org study id: 5-week Identity intervention
nct id: NCT04416074
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This is an online 5-week group psychological intervention for the nursing students during
      clinical rotation practice. It aims at promoting the professional identity and career
      sefl-efficacy for them.
Those 110 participants come from two classes in the same grade. One will be randomly
      allocated as the intervention group, the other will be control group. The intervention will
      be delivered via an online meeting software, like Zoom. The control group will received five
      messages fo self care messages forward by the researcher.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Professional identity
time frame: We will measure the score of professional identity before intervention and immediately after intervention.
description: Professional identity in recent one week measured by Chinese Profession identity scale for nursing student, ranging from 17 to 85, with higher score reflects higher level of idnetity.
measure: Career self-efficacy
time frame: We will measure the score of career self-efficacy before intervention and immediately after intervention.
description: Career self-efficacy in recent one week measured by the Chinese career self-efficacy scale for nursing student, ranging from 27-135, with higher score reflects higher level of career self-efficacy.
measure: Stress
time frame: We will measure the score of stress before intervention and immediately after intervention.
description: A reflection of one's perceived stress in recent month measured by the subscale from the Depression, Anxiety, and Stress Scale (DASS-21). The score rangs from 0-21, with higher score reflects higher level of stress.
measure: Resilience
time frame: We will measure the score of resilience before intervention and immediately after intervention.
description: Resilience in recent one week measured by the Chinese version of Connor-Davidson Resilience Scale-10. The score ranges from 0-40, with higher score reflects higher level of resilience.
measure: General rating
time frame: We will measure this immediately after intervention.
description: Several descriptive question to gather the feedback of the intervention. Each question will be rated from 0 to 5, with higher score reflects higher level of satisfaction.
arm group label: Group psychotherapy group
arm group type: Experimental
description: Students will be intervened by an online 5-week professional identity group psychotherapy.
arm group label: Controlled message push group
arm group type: Other
description: Students will receive online messages of self-care knowledge forward by researchers.
intervention type: Behavioral
intervention name: An online 5-week professional identity group psychotherapy
description: This is an online 5-week group psychological intervention for the nursing students during clinical rotation practice. It aims at promoting the professional identity and career sefl-efficacy for them. There are five sessions in the intervention, and each session lasts from 60min to 90min at each week. The intervention will be delivered via an online meeting software, like Zoom. There will be 15-20 students in one meeting group.
arm group label: Group psychotherapy group
intervention type: Other
intervention name: Message push
description: Controlled group will receive online messages of self-care knowledge forward by researchers once per week. The knowledge contain stress regulation, strategies for relaxation, self-protection during clinical practice.
arm group label: Controlled message push group
criteria: 
gender: All
gender based: Yes
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Anni Wang, Dr.
role: Principal Investigator
affiliation: School of Nursing, Fudan University
facility: 
country: China
citation: Ohlen J, Segesten K. The professional identity of the nurse: concept analysis and development. J Adv Nurs. 1998 Oct;28(4):720-7. doi: 10.1046/j.1365-2648.1998.00704.x.
PMID: 9829659
citation: Kirpal, S.J.C.D.I., Work identities of nurses: Between caring and efficiency demands. 2004.
citation: Roberts SJ. Development of a positive professional identity: liberating oneself from the oppressor within. ANS Adv Nurs Sci. 2000 Jun;22(4):71-82. doi: 10.1097/00012272-200006000-00007.
PMID: 10852670
citation: Megginson LA. RN-BSN education: 21st century barriers and incentives. J Nurs Manag. 2008 Jan;16(1):47-55. doi: 10.1111/j.1365-2934.2007.00784.x.
PMID: 18211335
citation: Cook TH, Gilmer MJ, Bess CJ. Beginning students' definitions of nursing: an inductive framework of professional identity. J Nurs Educ. 2003 Jul;42(7):311-7. doi: 10.3928/0148-4834-20030701-08.
PMID: 12873061
citation: Hunter B, Segrott J. Re-mapping client journeys and professional identities: a review of the literature on clinical pathways. Int J Nurs Stud. 2008 Apr;45(4):608-25. doi: 10.1016/j.ijnurstu.2007.04.001. Epub 2007 May 23.
PMID: 17524406
citation: Yamagishi M, Kobayashi T, Nakamura Y. Effects of web-based career identity training for stress management among Japanese nurses: a randomized control trial. J Occup Health. 2008;50(2):191-3. doi: 10.1539/joh.l7086. No abstract available.
PMID: 18403870
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Anni Wang
investigator title: Principal Investigator
sharing ipd: No
ipd description: The participants are not willing to share the data.
provided document: 