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
About this trial
This is an interventional supportive care trial for Burn Out (Psychology) focused on measuring resident, surgery, ego resilience, mindfulness
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
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
NCT ID
NCT04857567
First Posted
April 7, 2021
Last Updated
July 21, 2021
Sponsor
Seoul National University Hospital
Collaborators
Mind Works Clinical Psychologist Group
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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