The Effect of Neurofeedback-assisted Mindfulness Training in Employees With Emotional Labor
9 stycznia 2019 zaktualizowane przez: Seoul National University Hospital
The Effect of Neurofeedback-assisted Mindfulness Training on Stress Reduction in Employees With Emotional Labor
The purpose of this study is to verify the effect of neurofeedback-assisted mindfulness training for workers.
Subjects who can participate in the screening are assigned to one neurofeedback-assisted mindfulness training group, mindfulness only training group, and self-treatment group.
The neurofeedback-assisted mindfulness group and the mindfulness group meet with psychologist and have education for the mindfulness training with or without neurofeedback respectively, a total of 4 times, once a week.
On the other hand, the self-treatment group provides self-education by providing the stress education kit.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
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 neurofeedback-assisted mindfulness and mindfulness training group will have education sessions with a psychologist for 30 minutes at a time, once a week, for a total of 4 sessions (one month for a period).
The education includes the instruction of the application including mindfulness training, with or without neurofeedback, and the review for the accomplishment of the training.
Participants should follow the instruction and the training schedule which is arranged in advance.
On the other hand, for a self-care control, the education sessions are not provided and self-learning materials are provided once a week.
The purpose of the study is to find the effectiveness of mindfulness training on reduction of stress and severity of emotional labor.
Especially, mindfulness training group with neurofeedback might be expected to show the highest improvement in various clinical scales and biomarkers including EEG and HRV.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
96
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Gyeonggi-do
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Seongnam, Gyeonggi-do, Republika Korei, 13605
- Seoul National University Bundang Hospital
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
19 lat do 65 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
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., the dose must be stabilized for last 6 months, 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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Mindfulness training with neurofeedback
mindfulness training with neurofeedback using mobile application instruction and review of the application will be provided
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mindfulness training using mobile application
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Aktywny komparator: Mindfulness training
mindfulness training using mobile application instruction and review of the application will be provided
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mindfulness training using mobile application
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Brak interwencji: Self-care
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks
Ramy czasowe: Baseline and after 4, 8 weeks later
|
The full name: Perceived Stress Scale - 10 item form 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.
Although the 14-item PSS tend to exhibit good reliability, four of the items tend to perform poorly when evaluated using exploratory factor analysis (Cohen et al., 1988).
As a result, the PSS is commonly implemented using the 10-item form.
The questions are rated on 5-point Likert scale; 0 (never), 1 (almost never), 2 (sometimes), 3 (fairly often), 4 (very often).
Higher scores represent worse outcomes.
The scores of each scale sum into the total score.
Thus the total score ranges from 0 to 40.
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Baseline and after 4, 8 weeks later
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change from baseline Korean Emotional Labor Assessment Tool score
Ramy czasowe: Baseline and after 4, 8 weeks later
|
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.
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Baseline and after 4, 8 weeks later
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Change from baseline Korean abbreviation of Occupational Stress Scale (KOSS) score
Ramy czasowe: Baseline and after 4, 8 weeks later
|
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.
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Baseline and after 4, 8 weeks later
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Change from baseline Patient Health Questionnaire 9 (PHQ-9) score
Ramy czasowe: Baseline and after 4, 8 weeks later
|
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.
|
Baseline and after 4, 8 weeks later
|
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Change from baseline Brief resilience scale (BRS) score
Ramy czasowe: Baseline and after 4, 8 weeks later
|
It is composed of 6 questions and is evaluated on the 5-point scale (1: not at all, 5: very much)
|
Baseline and after 4, 8 weeks later
|
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Change from baseline Athens Insomnia Scale (AIS) score
Ramy czasowe: Baseline and after 4, 8 weeks later
|
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
|
Baseline and after 4, 8 weeks later
|
|
Korean Mindful Attention Awareness Scale; K-MAAS
Ramy czasowe: Baseline and after 4, 8 weeks later
|
Modified from the Mindful Attention Awareness Scale, developed by Brown and Ryan (2003).
15-item scale designed to assess a core characteristic of dispositional mindfulness, namely, open or receptive awareness of and attention to what is taking place in the present.
|
Baseline and after 4, 8 weeks later
|
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Stroop test
Ramy czasowe: Baseline and after 4, 8 weeks later
|
assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute
|
Baseline and after 4, 8 weeks later
|
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Heart Rate Variability (HRV)
Ramy czasowe: Baseline and after 4, 8 weeks later
|
HRV is recorded with a device (neuroNicle FX2, Laxtha) which include EEG and HRV recording system.
HRV is calculated from pulse rate signal recorded at earlobe.
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Baseline and after 4, 8 weeks later
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Quantitative electroencephalography (QEEG)
Ramy czasowe: Baseline and after 4, 8 weeks later
|
EEG is recorded with a device (neuroNicle FX2, Laxtha) which include EEG and HRV recording system. EEG signal is acquired at the prefrontal area, two channels (FP1, FP2) on forehead. Power spectrum analysis of the EEG data will be performed using Fourier analysis. And absolute power, relative power, of each frequency band, symmetry are included. |
Baseline and after 4, 8 weeks later
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Śledczy
- Główny śledczy: Jeong Hyun Kim, MD, Ph.D, Seoul National Univerysity Bundang Hospital
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
7 sierpnia 2018
Zakończenie podstawowe (Rzeczywisty)
31 grudnia 2018
Ukończenie studiów (Rzeczywisty)
31 grudnia 2018
Daty rejestracji na studia
Pierwszy przesłany
23 grudnia 2018
Pierwszy przesłany, który spełnia kryteria kontroli jakości
23 grudnia 2018
Pierwszy wysłany (Rzeczywisty)
26 grudnia 2018
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
11 stycznia 2019
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
9 stycznia 2019
Ostatnia weryfikacja
1 grudnia 2018
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- B-1807/483-303
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .