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The Efficacy of Mobile Video Counseling for Employees With Emotional Labor

Primary Purpose

Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Stress management counseling
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress, Psychological focused on measuring Resilience, Mobile video counseling, Emotiona labor

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Workers over the age of 19 and under 65
  • In the Perceived Stress Scale 14 points or more
  • If you are currently taking medication due to psychiatric illnesses such as depression, anxiety disorder, insomnia, etc., if the stabilizer is expected to have no change in drug dose during the clinical trial
  • If you understand the protocol and voluntarily agree to participate
  • If you have an Android phone

Exclusion Criteria:

  • Age under 19, adult over 65
  • If you have dementia, intellectual disability, or other cognitive impairment
  • If you have convulsive disorder, stroke, or other neurological disorder
  • If you have psychosis such as schizophrenia or bipolar disorder or you have a history
  • If you have a disease that can affect the reliability of HRV test, such as heart disease or lung disease.
  • Has received non-pharmacological psychiatric or counseling treatment within the current or last 6 months.

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Mobile Video Counseling

Offline Counseling

Selfcare

Arm Description

Utilize mobile imaging equipment, receive a total of 4 stress management consultations every 50 minutes at a time, once a week.

Receive a total of 4 stress management counseling, once a week for 50 minutes each session.

Use stress management materials to manage yourself.

Outcomes

Primary Outcome Measures

Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks
14-item scale developed by Cohen et al. (1983) that emphasizes subjective perception of stress. Measures the degree of perceived unforeseeable, uncontrollable, and overwhelming experience of stress in the past month.

Secondary Outcome Measures

Change from baseline Korean Emotional Labor Assessment Tool score at 4, 8 weeks
The total of 26 items were Emotional expression and control 5 items, organizational monitoring and management system 4 items, forced customer response 4 items, emotional damage 6 items, organizational protection system 7 items, and organizational protection system is reverse coding and summed up. 4 point Likert scale (1 = not at all, 5 = very much), and the possible total score ranges from 26 to 130 points. The higher the score, the more emotional labor means.
Change from baseline Korean abbreviation of Occupational Stress Scale (KOSS) score at 4, 8 weeks
total of 24 items were used, and each item was not at all (from 1 point) to very much (5 points). The higher the score, the more the job stress means. Job demand, Insufficient job control, job insecurity, interpersonal conflict, Organizational system, Lack of reward and Occupational climate.
Change from baseline Patient Health Questionnaire 9 (PHQ-9) score at 4, 8 weeks
The total score is 0 to 27, and the higher the total score, the more severe the depressive symptoms. Cutpoints of 5, 10, 15 and 20 represent the thresholds for mild, moderate, moderate severe, and severe depression, respectively.
Change from baseline Brief resilience scale (BRS) score at 4, 8 weeks
It is composed of 6 questions and is evaluated on the 5-point scale (1: not at all, 5: very much)
Change from baseline Athens Insomnia Scale (AIS) score at 4, 8 weeks
total score of 6 points was used as a breakpoint, this Using the quality index of Pittsburgh Sleep, which is widely used to evaluate the quality of sleep
Change from baseline Depression, Anxiety, Stress Scale (DASS) score at 4, 8 weeks
A total of 21 questions, depression, anxiety, and stress were assessed on a 4-point scale (0: not at all, 3: very or almost always). In this study, only 7 items relating to anxiety were extracted. The lowest score is from 0 to the maximum score of 21, and the higher the score, the more severe anxiety. Anxiety scores above 8 indicate significant anxiety symptoms
Change from baseline Connor-Davidson Resilience Scale (CD-RISC) score at 4, 8 weeks
A total of 25 items were assessed as a 5-point Likert scale (0: not at all, 4: very much). A score of 0-100 means higher resilience
Change from baseline Maslach Burnout Inventory-General Survey (MBI-GS) score at 4, 8 weeks
Evaluate on a total of 16 questions on a 7 point scale (1 point = not at all, 7 points = very much). The higher the total score, the greater the degree of job exhaustion.
Change from baseline Heart rate variability (HRV) and Change from baseline Eletroencephalogram (EEG) score at 4, 8 weeks
The instrument measures the EEG from the headset forehead sensor (EEG measurement of the prefrontal lobe, 2 channel EEG) and measures the pulse at the earlobe (measure the pulse rate in the earlobe vessel using a light sensor). The results of EEG and heart rate variability were calculated by measuring for 5 minutes.

Full Information

First Posted
August 18, 2017
Last Updated
April 4, 2019
Sponsor
Seoul National University Hospital
Collaborators
Ministry of Trade, Industry & Energy, Republic of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT03256682
Brief Title
The Efficacy of Mobile Video Counseling for Employees With Emotional Labor
Official Title
The Efficacy of a Mobile Video Counseling Targeted for Stress Reduction and Resilience Enhancement in Employees With Emotional Labor
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2, 2017 (Actual)
Primary Completion Date
July 3, 2018 (Actual)
Study Completion Date
July 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
Ministry of Trade, Industry & Energy, Republic of Korea

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
The purpose of this study is to verify the effectiveness of mobile video counseling for workers. Subjects who can participate in the screening evaluation are assigned to one of face-to-face counseling group, mobile counseling group, and self-treatment group. The mobile counseling group and the face-to-face counseling group counseld with a total of 4 times, 50 minutes at a time, once a week, and the self-treatment group provides self-education by providing the stress education kit.
Detailed Description
After screening, Pre-evaluation is conducted on the subjects who agreed to participate in the study. Pre-assessment includes questionnaires related to stress, emotional labor, resilience, sleep, etc., and includes stress-related physiological measures using HRV, 2 lead EEG. After the pre-evaluation, the test group will conduct a counseling program with a psychologist for 50 minutes at a time, once a week, for a total of 4 sessions (one month for a period). The place should be placed in a quiet place where the subject thinks comfortably and is designated as the same place to exclude the influence by the place, but the subject does not have to visit the hospital. In the offline counseling group, four counseling sessions are held with the psychologist off-line for a total of 4 counseling sessions, 50 minutes at a time, once a week after the same pre-evaluation. As a self-care control, counseling is not provided and self-learning materials are provided once a week. Mobile counseling group and offline counseling group visit the hospital within one week after termination and within 4 to 5 weeks after pre-evaluation in self-care control group. Also, to see if the effect of mobile counseling is continued even after counseling is completed, visit the counseling clinic one month after counseling is over and conduct the same test. The data obtained from this study showed that the mobile counseling program measured the change in the clinical scale and heart rate variability and EEG such as the stress and resilience of the subjects, and the self-care group using the offline counseling group and stress data and stress related psychological and physiological And compare the effects on the improvement of the indicator.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological
Keywords
Resilience, Mobile video counseling, Emotiona labor

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Healthy individuals recruited through advertisement
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile Video Counseling
Arm Type
Experimental
Arm Description
Utilize mobile imaging equipment, receive a total of 4 stress management consultations every 50 minutes at a time, once a week.
Arm Title
Offline Counseling
Arm Type
Active Comparator
Arm Description
Receive a total of 4 stress management counseling, once a week for 50 minutes each session.
Arm Title
Selfcare
Arm Type
No Intervention
Arm Description
Use stress management materials to manage yourself.
Intervention Type
Behavioral
Intervention Name(s)
Stress management counseling
Intervention Description
stress management counseling based on CBT and relaxation
Primary Outcome Measure Information:
Title
Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks
Description
14-item scale developed by Cohen et al. (1983) that emphasizes subjective perception of stress. Measures the degree of perceived unforeseeable, uncontrollable, and overwhelming experience of stress in the past month.
Time Frame
Baseline and after 4, 8 weeks later
Secondary Outcome Measure Information:
Title
Change from baseline Korean Emotional Labor Assessment Tool score at 4, 8 weeks
Description
The total of 26 items were Emotional expression and control 5 items, organizational monitoring and management system 4 items, forced customer response 4 items, emotional damage 6 items, organizational protection system 7 items, and organizational protection system is reverse coding and summed up. 4 point Likert scale (1 = not at all, 5 = very much), and the possible total score ranges from 26 to 130 points. The higher the score, the more emotional labor means.
Time Frame
Baseline and after 4, 8 weeks later
Title
Change from baseline Korean abbreviation of Occupational Stress Scale (KOSS) score at 4, 8 weeks
Description
total of 24 items were used, and each item was not at all (from 1 point) to very much (5 points). The higher the score, the more the job stress means. Job demand, Insufficient job control, job insecurity, interpersonal conflict, Organizational system, Lack of reward and Occupational climate.
Time Frame
Baseline and after 4, 8 weeks later
Title
Change from baseline Patient Health Questionnaire 9 (PHQ-9) score at 4, 8 weeks
Description
The total score is 0 to 27, and the higher the total score, the more severe the depressive symptoms. Cutpoints of 5, 10, 15 and 20 represent the thresholds for mild, moderate, moderate severe, and severe depression, respectively.
Time Frame
Baseline and after 4, 8 weeks later
Title
Change from baseline Brief resilience scale (BRS) score at 4, 8 weeks
Description
It is composed of 6 questions and is evaluated on the 5-point scale (1: not at all, 5: very much)
Time Frame
Baseline and after 4, 8 weeks later
Title
Change from baseline Athens Insomnia Scale (AIS) score at 4, 8 weeks
Description
total score of 6 points was used as a breakpoint, this Using the quality index of Pittsburgh Sleep, which is widely used to evaluate the quality of sleep
Time Frame
Baseline and after 4, 8 weeks later
Title
Change from baseline Depression, Anxiety, Stress Scale (DASS) score at 4, 8 weeks
Description
A total of 21 questions, depression, anxiety, and stress were assessed on a 4-point scale (0: not at all, 3: very or almost always). In this study, only 7 items relating to anxiety were extracted. The lowest score is from 0 to the maximum score of 21, and the higher the score, the more severe anxiety. Anxiety scores above 8 indicate significant anxiety symptoms
Time Frame
Baseline and after 4, 8 weeks later
Title
Change from baseline Connor-Davidson Resilience Scale (CD-RISC) score at 4, 8 weeks
Description
A total of 25 items were assessed as a 5-point Likert scale (0: not at all, 4: very much). A score of 0-100 means higher resilience
Time Frame
Baseline and after 4, 8 weeks later
Title
Change from baseline Maslach Burnout Inventory-General Survey (MBI-GS) score at 4, 8 weeks
Description
Evaluate on a total of 16 questions on a 7 point scale (1 point = not at all, 7 points = very much). The higher the total score, the greater the degree of job exhaustion.
Time Frame
Baseline and after 4, 8 weeks later
Title
Change from baseline Heart rate variability (HRV) and Change from baseline Eletroencephalogram (EEG) score at 4, 8 weeks
Description
The instrument measures the EEG from the headset forehead sensor (EEG measurement of the prefrontal lobe, 2 channel EEG) and measures the pulse at the earlobe (measure the pulse rate in the earlobe vessel using a light sensor). The results of EEG and heart rate variability were calculated by measuring for 5 minutes.
Time Frame
Baseline and after 4, 8 weeks later
Other Pre-specified Outcome Measures:
Title
Counseling Satisfaction Scale
Description
Evaluate within 7 days of closing psychological counseling. Twelve questions to evaluate the quality of psychological counseling, content, psychological counselor 's attitude, procedures, and six questions to measure accessibility and a written description question for the proposal. The mobile group further includes questions such as system speed, image quality, sound and so on. Evaluating from not at all (1 point) very much (5 points), which means that the higher the score is, the higher the degree of satisfaction is.
Time Frame
After 4 weeks intervention
Title
Change from baseline Working Memory score at 4, 8 weeks
Description
Measure short-term memory, work function known to be sensitive to stress. It consists of forward, backward, sequencing, scored 0 - 14 points, and means that the higher the score, the better the function.
Time Frame
Baseline and after 4, 8 weeks later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Workers over the age of 19 and under 65 In the Perceived Stress Scale 14 points or more If you are currently taking medication due to psychiatric illnesses such as depression, anxiety disorder, insomnia, etc., if the stabilizer is expected to have no change in drug dose during the clinical trial If you understand the protocol and voluntarily agree to participate If you have an Android phone Exclusion Criteria: Age under 19, adult over 65 If you have dementia, intellectual disability, or other cognitive impairment If you have convulsive disorder, stroke, or other neurological disorder If you have psychosis such as schizophrenia or bipolar disorder or you have a history If you have a disease that can affect the reliability of HRV test, such as heart disease or lung disease. Has received non-pharmacological psychiatric or counseling treatment within the current or last 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Hyun Kim, MD, Ph.D
Organizational Affiliation
Seoul National Univerysity Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
13605
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32627860
Citation
Kunzler AM, Helmreich I, Chmitorz A, Konig J, Binder H, Wessa M, Lieb K. Psychological interventions to foster resilience in healthcare professionals. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD012527. doi: 10.1002/14651858.CD012527.pub2.
Results Reference
derived
PubMed Identifier
30348630
Citation
Kim JI, Yun JY, Park H, Park SY, Ahn Y, Lee H, Kim TK, Yoon S, Lee YJ, Oh S, Denninger JW, Kim BN, Kim JH. A Mobile Videoconference-Based Intervention on Stress Reduction and Resilience Enhancement in Employees: Randomized Controlled Trial. J Med Internet Res. 2018 Oct 22;20(10):e10760. doi: 10.2196/10760.
Results Reference
derived

Learn more about this trial

The Efficacy of Mobile Video Counseling for Employees With Emotional Labor

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