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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04964102
Other study ID # 20MMHIS092e
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 14, 2020
Est. completion date May 13, 2022

Study information

Verified date August 2021
Source Mackay Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to explore associations of burn out, stress, communication skills, interpersonal effectiveness and empathy level using data collected in pre and post assessments from "Workshop of Enhancing Interpersonal Effectiveness, Emotional Regulation and Clinical Communication Skills".


Description:

The medical community is paying more and more attention to the nature of burnout, physiological, or physical stress of health care professionals (HCP). Burn out and stress not only affects the HCP themselves, but subsequently their team members, medical institutions, and patients. Recent research has found that HCP's stress, burnout, and dissatisfaction with work are associated with their practice time and leaving the job; as well as declines in quality of care, poor patient results, and medical errors. There seems to be a two-way correlation between burn out and empathy. On the one hand, the more burn out, the lower the degree of empathy; on the other hand, the deficits in perspective substitution seems to be a risk factor for burn out. The increase in multiple perspectives and empathic attention seems prevent burn out. Other studies found that practicing clinical communication skills through practices and role-plays, and using emotional regulation methods to enable participants to express their attitudes and feelings about communicating difficult problems may help HCP improve their degree of empathy and communication skills. When such communication courses add combinations of stress management and social skills training can not only improve communication skills, increase empathy, but also prevent burnout and exhaustion. Therefore, this study aims to explore associations of burn out, stress, communication skills, interpersonal effectiveness, and empathy level using data collected in pre- and post- assessments from 'Workshops of Enhancing Interpersonal Effectiveness, Emotional Regulation, and Clinical Communication Skills'. Before and after the workshop, information regarding HCP's burn out, perceived stress, empathy level, and interpersonal effectiveness will be assessed in order to understand whether the workshop has reached its goals and teaching effectiveness. All information regarding personal data will be de-identified and encrypted. These assessments are designed to evaluate the effectiveness of teaching activities in a general teaching environment. This study will also focus on the reliability and validity analysis of the short form research measures which used. It will conduct validation studies comparing the Chinese version of the measures which used with internationally well known but long research measures to make sure the reliability and validity. If these shorter forms have well validity, it may be able to use the short and simplified questionnaires for related research in the future.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date May 13, 2022
Est. primary completion date May 13, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria: - age between 20 and 65 years old - willing to attend the workshop and willing to participate this study Exclusion Criteria: - age less than 20 or over 65 years old

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Workshop of Enhancing Interpersonal Effectiveness, Emotional Regulation and Clinical Communication Skills
Workshop of Enhancing Interpersonal Effectiveness, Emotional Regulation and Clinical Communication Skills

Locations

Country Name City State
Taiwan Mackay Memorial Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Perceived Stress Scale (PSS) Score before and after workshop and Week 24 Assessed The PSS scores is a rating tool used to gauge the course of stree. The minimum total score possible is 0 and the maximum total score possible is 40. Higher values represent a worse outcome. Before and after workshop and 24 weeks
Secondary Differences in Empathy Scale before and after workshop and Week 24 Assessed The Empathy Scale is one of the first measures to achieve widespread use, contains four separate dimensions: social self-confidence, even-temperedness, sensitivity, and nonconformity. The instrument is scored on a scale of 0 (being the least empathetic possible) to 80 (being the most empathetic possible). Before and after workshop and 24 weeks
Secondary Differences in Insomnia Severity index (ISI) before and after workshop and Week 24 Assessed The ISI is a rating tool used to gauge of sleeping. Higher values represent a worse outcome. Before and after workshop and 24 weeks
Secondary Differences in the State and Trait Anxiety Index (STAI) before and after the workshop and Week 24 Assessed The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety. Before and after workshop and 24 weeks
Secondary Differences in Generalized Anxiety Disorder 7-item (GAD-7) before and after the workshop and Week 24 Assessed Self-administered 7 item instrument that uses some of the DSM-V criteria for GAD (General Anxiety Disorder) to identify probable cases of GAD along with measuring anxiety symptom severity. It can also be used as a screening measure of panic, social anxiety, and PTSD. It was modeled after the PHQ9 to be used quickly and effectively within a primary care setting. Before and after workshop and 24 weeks
Secondary Differences in Patient Health Questionnaire-9 (PHQ-9) before and after the workshop and Week 24 Assessed The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Before and after workshop and 24 weeks
Secondary Differences in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) before and after the workshop and Week 24 Assessed Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF; Endicott et al,1993). The Q-LES-Q-SF evaluates general activities that are assessed in the longer form of the Q- LES-Q. Each item uses a 5-point scale ranging from 1 (very poor) to 5 (very good). A total score is derived from 14 items with a maximum score of 70 and with higher scores indicating greater life satisfaction and enjoyment. Before and after workshop and 24 weeks
Secondary Differences in Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL) before and after the workshop and Week 24 Assessed Differences in Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL) may have coped with stressful events in life. The Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL) is a 59-item self-report scale designed to assess participants' use of DBT skills (e.g., acceptance, cognitive reappraisal, problem-solving) and maladaptive coping responses. The DBT-WCCL is a checklist designed to gauge ways of coping. As subjects go through the 59 questions, they can think about and evaluate different ways in which they may have coped with stressful events in life. Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL) effective coping subscale. Minimum score: 0. Maximum score: 3. Higher score indicates more frequent use of adaptive coping strategies. Lower score indicates less frequent use of adaptive coping strategies. Before and after workshop and 24 weeks
Secondary Differences in Jefferson Scale of Empathy (JSE) before and after the workshop and Week 24 Assessed The Jefferson Scale of Empathy (JSE) is to measure empathy in physicians, and other health professionals involved in patient care in a clinical setting; as well as students studying medicine and other forms of health care in preparation for working in a clinical setting. The minimum and maximum scores for JSE-HPS can be reached to 20 and 140, respectively. The more the higher scores indicate more empathic aspect or vice versa. Before and after workshop and 24 weeks
Secondary Differences in Interpersonal Reactivity Index (IRI) before and after the workshop and Week 24 Assessed The Interpersonal Reactivity Index (IRI) is a published measurement tool for the multi-dimensional assessment of empathy. 28 items using 5-point scales (A = does not describe me well to E = describes me very well) Sub-scales 4 sub-scales, each with 7 items: Fantasy assesses the extent to which individuals identify with fictional characters.
Perspective-taking assesses the extent to which individuals spontaneously (try to) adopt others' points of view.
Empathetic concern assesses the extent of individuals' "feelings of warmth, compassion, and concern for others." Personal distress assesses the extent of individuals "feelings of anxiety and discomfort" as a result of "another's negative experience." scores would range from 28 to 140
Before and after workshop and 24 weeks
Secondary Differences in Maslach Burnout Inventory (MBI) before and after the workshop and Week 24 Assessed The Maslach Burnout Inventory (MBI) is a psychological assessment instrument comprising 22 symptom items pertaining to occupational burnout. All MBI items are scored using a 7 level frequency ratings from "never" to "daily." The MBI has three component scales: emotional exhaustion (9 items), depersonalization (5 items) and personal achievement (8 items). Each scale measures its own unique dimension of burnout. Scales should not be combined to form a single burnout scale. Maslach, Jackson, and Leiter[1] described item scoring from 0 to 6. There are score ranges that define low, moderate and high levels of each scale based on the 0-6 scoring. Before and after workshop and 24 weeks
Secondary Differences in Professional Fulfillment Index (PFI) before and after the workshop and Week 24 Assessed Professional Fulfillment Index (PFI) is a 16-item instrument to assess physicians' professional fulfillment and burnout, designed for sensitivity to change attributable to interventions or other factors affecting physician well-being. All burnout items are scored on a 5-point Likert scale with options ranging from "not at all" to "extremely" for burnout items and "not at all true" to "completely true" for professional fulfillment items. Aggregate scores for burnout and professional fulfillment were calculated using the published approach, with possible scores ranging from 0 to 40 and 0 to 24, respectively. Before and after workshop and 24 weeks
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