- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03787407
The Effect of Neurofeedback-assisted Mindfulness Training in Employees With Emotional Labor
The Effect of Neurofeedback-assisted Mindfulness Training on Stress Reduction in Employees With Emotional Labor
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Gyeonggi-do
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Seongnam, Gyeonggi-do, Corea, Repubblica di, 13605
- Seoul National University Bundang Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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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Comparatore attivo: 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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Nessun intervento: Self-care
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks
Lasso di tempo: 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.
|
Baseline and after 4, 8 weeks later
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change from baseline Korean Emotional Labor Assessment Tool score
Lasso di tempo: 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
|
Change from baseline Korean abbreviation of Occupational Stress Scale (KOSS) score
Lasso di tempo: 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.
|
Baseline and after 4, 8 weeks later
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Change from baseline Patient Health Questionnaire 9 (PHQ-9) score
Lasso di tempo: 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
|
Change from baseline Brief resilience scale (BRS) score
Lasso di tempo: 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
|
Change from baseline Athens Insomnia Scale (AIS) score
Lasso di tempo: 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
Lasso di tempo: 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.
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Baseline and after 4, 8 weeks later
|
Stroop test
Lasso di tempo: 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
|
Heart Rate Variability (HRV)
Lasso di tempo: 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.
|
Baseline and after 4, 8 weeks later
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Quantitative electroencephalography (QEEG)
Lasso di tempo: 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
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Jeong Hyun Kim, MD, Ph.D, Seoul National Univerysity Bundang Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- B-1807/483-303
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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