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The Efficacy Study of the Evidence-Based Psychological Intervention for Improving Resilience and Preventing Burnout of Residents

Primary Purpose

Burn Out (Psychology)

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TSC program (Three Self-Commitment program)
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Burn Out (Psychology) focused on measuring resident, surgery, ego resilience, mindfulness

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Surgical trainees (residents and clinical fellows) at Bundang Seoul National University Hospital, who is 20 years of age or older, regardless of sex or race.

Exclusion Criteria:

  • Subjects who do not consent to the study
  • Subjects with meditation experience

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Three Self-Commitment (TSC) program

    Arm Description

    Outcomes

    Primary Outcome Measures

    TCI, Temperament and Character Inventory
    A test developed by Clononger, Przybeck, Svrakic and Wetzel (1994) and currently widely used in various countries such as the United States, France, and Spain. A tool that measures personality traits such as autonomy, solidarity, and self-transcendence, along with individual traits such as stimulation seeking, risk aversion, social sensitivity, and endurance. In this study, the Korean version (Min et al., 2007) of the German version of TCI-RS, the standardized test, is adapted : Based on the test result, the individual's personality characteristics of the resident are identified and applied.
    MBI, Maslach Burnout Inventory
    As a test developed by Maslach and Jackson (1981), MBI is a tool that measures the sub-concepts of burnout, such as emotional burnout, dehumanization, and personal sense of accomplishment. MBI is a measurement tool used in more than 90% of empirical exhaustion research worldwide, and a test developed to measure the exhaustion of personnel providing interpersonal services including medical workers. In this study, MBI adapted and validated by Kang Jeong-hee and Kim Cheol-woong (2012) is used. Participate in the program according to the type of burnout of the client and measure the change in the burnout level of the participants before and after.
    ER89, Ego Resilience Scale
    A test developed by Block and Kremen (1996) that measures sub-concepts of self-elasticity such as interpersonal relationships, vitality, emotional control, curiosity, and optimism. In this study, a scale adapted by Park Eun-hee (1997), which was verified as 76-79, is used and measures the change in the participant's ego-elasticity before and after participating in the program.
    DASS-21, Depression Anxiety StressScale
    A test developed by Lovibond and Lovibond (1995) to measure depression, anxiety, and stress corresponding to psychological distress. The internal agreement was verified as 0.87~0.91, 0.83~0.89, and 0.83~0.92 for depression, anxiety, and stress, respectively (Youngsun Lee et al, 2019; Jun et al, 2018).
    Subjective Well-being
    A test developed by Diener E (1985) to measure subjective satisfaction with daily life. A tool showing the internal consistency reliability of 0.87 and the test-retest reliability of 0.82.
    SCS, Self-Compassion Scale
    Developed by Neff (2003) and validated as a Korean version by Kim et al. (2008) / 26 items / 6 sub-factors: self-kindness, self-judgment, universal humanity, isolation, mindfulness, hyper-identification on a 5-point scale (minimum 6 to maximum 30, the higher the score, the better the outcome)

    Secondary Outcome Measures

    Full Information

    First Posted
    April 7, 2021
    Last Updated
    July 21, 2021
    Sponsor
    Seoul National University Hospital
    Collaborators
    Mind Works Clinical Psychologist Group
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04857567
    Brief Title
    The Efficacy Study of the Evidence-Based Psychological Intervention for Improving Resilience and Preventing Burnout of Residents
    Official Title
    The Efficacy Study of the Evidence-Based Psychological Intervention for Improving Resilience and Preventing Burnout of Residents
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2021 (Anticipated)
    Primary Completion Date
    February 28, 2022 (Anticipated)
    Study Completion Date
    July 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Hospital
    Collaborators
    Mind Works Clinical Psychologist Group

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    There are few systematic studies on the working environment and mental health of residents who are at the forefront of Korean medical care. In particular, there is no scientific research on burnout prevention. Since preventing burnout of surgical residents is directly related not only to personal well-being but the health of the patients, it is necessary to care for the individual's psychological state at a social level. This psychological intervention program that is expected to improve recovery resilience in stressful situations of residents and prevent burnout is implemented, and its effectiveness is to be verified.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Burn Out (Psychology)
    Keywords
    resident, surgery, ego resilience, mindfulness

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Three Self-Commitment (TSC) program
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    TSC program (Three Self-Commitment program)
    Intervention Description
    Self-Competence program - A program for residents who experience exhaustion due to the spirit of volunteerism and high expectations of therapeutic competency in the case of experiencing a decrease in personal achievement. Self-Care program - A program to help individuals who experience dehumanization due to emotional suppression and develop exhaustion in the process of suppressing emotions to protect themselves from excessive feelings of compassion experienced in the medical scene Self-Compassion program - A program for residents who experience emotional burnout and exhaustion due to pressure of failure because medical professionals should be competent and excellent
    Primary Outcome Measure Information:
    Title
    TCI, Temperament and Character Inventory
    Description
    A test developed by Clononger, Przybeck, Svrakic and Wetzel (1994) and currently widely used in various countries such as the United States, France, and Spain. A tool that measures personality traits such as autonomy, solidarity, and self-transcendence, along with individual traits such as stimulation seeking, risk aversion, social sensitivity, and endurance. In this study, the Korean version (Min et al., 2007) of the German version of TCI-RS, the standardized test, is adapted : Based on the test result, the individual's personality characteristics of the resident are identified and applied.
    Time Frame
    Change from baseline at right after 6 cycles of TSC program (up to 24 weeks from baseline)
    Title
    MBI, Maslach Burnout Inventory
    Description
    As a test developed by Maslach and Jackson (1981), MBI is a tool that measures the sub-concepts of burnout, such as emotional burnout, dehumanization, and personal sense of accomplishment. MBI is a measurement tool used in more than 90% of empirical exhaustion research worldwide, and a test developed to measure the exhaustion of personnel providing interpersonal services including medical workers. In this study, MBI adapted and validated by Kang Jeong-hee and Kim Cheol-woong (2012) is used. Participate in the program according to the type of burnout of the client and measure the change in the burnout level of the participants before and after.
    Time Frame
    Change from baseline at right after 6 cycles of TSC program (up to 24 weeks from baseline)
    Title
    ER89, Ego Resilience Scale
    Description
    A test developed by Block and Kremen (1996) that measures sub-concepts of self-elasticity such as interpersonal relationships, vitality, emotional control, curiosity, and optimism. In this study, a scale adapted by Park Eun-hee (1997), which was verified as 76-79, is used and measures the change in the participant's ego-elasticity before and after participating in the program.
    Time Frame
    Change from baseline at right after 6 cycles of TSC program (up to 24 weeks from baseline)
    Title
    DASS-21, Depression Anxiety StressScale
    Description
    A test developed by Lovibond and Lovibond (1995) to measure depression, anxiety, and stress corresponding to psychological distress. The internal agreement was verified as 0.87~0.91, 0.83~0.89, and 0.83~0.92 for depression, anxiety, and stress, respectively (Youngsun Lee et al, 2019; Jun et al, 2018).
    Time Frame
    In this study, changes in participant's psychological pain are measured at each session during the program (6 cycles of TSC program, 3-4 weeks interval, up to 24 weeks from baseline).
    Title
    Subjective Well-being
    Description
    A test developed by Diener E (1985) to measure subjective satisfaction with daily life. A tool showing the internal consistency reliability of 0.87 and the test-retest reliability of 0.82.
    Time Frame
    Change from baseline at right after 6 cycles of TSC program (up to 24 weeks from baseline)
    Title
    SCS, Self-Compassion Scale
    Description
    Developed by Neff (2003) and validated as a Korean version by Kim et al. (2008) / 26 items / 6 sub-factors: self-kindness, self-judgment, universal humanity, isolation, mindfulness, hyper-identification on a 5-point scale (minimum 6 to maximum 30, the higher the score, the better the outcome)
    Time Frame
    Change from baseline at right after 6 cycles of TSC program at the end of Cycle 6 (each cycle is 4 weeks, up to 24 weeks from baseline)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Surgical trainees (residents and clinical fellows) at Bundang Seoul National University Hospital, who is 20 years of age or older, regardless of sex or race. Exclusion Criteria: Subjects who do not consent to the study Subjects with meditation experience
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Heung-Kwon Oh, PhD
    Phone
    +82-31-787-7105
    Email
    crsohk@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Heung-Kwon Oh, PhD
    Organizational Affiliation
    Seoul National University Bundang Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    The Efficacy Study of the Evidence-Based Psychological Intervention for Improving Resilience and Preventing Burnout of Residents

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