NCT04857567

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 23, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

6 months

First QC Date

April 7, 2021

Last Update Submit

July 21, 2021

Conditions

Keywords

residentsurgeryego resiliencemindfulness

Outcome Measures

Primary Outcomes (6)

  • 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.

    Change from baseline at right after 6 cycles of TSC program (up to 24 weeks from baseline)

  • 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.

    Change from baseline at right after 6 cycles of TSC program (up to 24 weeks from baseline)

  • 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.

    Change from baseline at right after 6 cycles of TSC program (up to 24 weeks from baseline)

  • 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).

    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).

  • 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.

    Change from baseline at right after 6 cycles of TSC program (up to 24 weeks from baseline)

  • 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)

    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)

Study Arms (1)

Three Self-Commitment (TSC) program

EXPERIMENTAL
Behavioral: TSC program (Three Self-Commitment program)

Interventions

1. 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. 2. 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 3. 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

Three Self-Commitment (TSC) program

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Heung-Kwon Oh, PhD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heung-Kwon Oh, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 7, 2021

First Posted

April 23, 2021

Study Start

September 1, 2021

Primary Completion

February 28, 2022

Study Completion

July 31, 2022

Last Updated

July 28, 2021

Record last verified: 2021-07