- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05242523
Automated Stress Detection and Restoration in Office Workers
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The experiment is divided into 2 main phases:
The first phase is the eustress-distress data collection: In this phase, participants will complete three conditions:
- "No-stress": Participants will sit idle on their desks without performing any task. This is important to record a baseline of physiological signals that will allow us to compare the physiological responses in later stages.
- "Low-stress work": Participants will be asked to prepare a brief presentation about a familiar topic (e.g., favorite types of food, TV shows, academic work). A strict time limit will not be provided; instead, participants will be told that they have at least 30 minutes and up to 40 minutes if they need that amount of time to complete the presentation.
- "High-stress work": Participants will be required to prepare a presentation about an unfamiliar topic with a time limit of 30 minutes. The topic and the requirements will be carefully established to make the completion of the presentation achievable but at the same time to create a sense of time pressure, heavy workload, and unfamiliarity with the task. We will employ a concept similar to the Trier Social Stress Test, in which participants are required to develop and deliver a speech to a panel. This test has been employed in several studies as a means of inducing high-stress reactions. In our study, participants will be informed that a two-person judging committee will be scoring their work performance by watching through a Zoom shared screen. Participants will be told that their final score will be compared to all other study participants such that the highest scoring individuals will receive an award. The committee's "score" will be presented on the screen beginning at 100 and will be decreased and increased in a standardized manner across all participants. Changes in the score will appear at uneven intervals such that the participants do not recognize a pattern but associate the scoring with the judging committee noticing some sort of work flaw or issue. A countdown clock with time remaining will be presented on the screen, recorded office noise (e.g., printers, distant chatting, computers) will be played in the background, and temperature will be increased outside the comfort range. In addition, participants will be subject to interruptions including pop-up messages, calls or emails every 5 minutes to ask about progress.
During the three conditions (idle, low stress, high stress) participants will be asked 5 questions every 5 minutes:
- In the last five minutes, to what extent did you consider the work you are performing as an opportunity or challenge?
- In the last five minutes, to what extent did you consider the work you are performing as a source of pressure?
- Over the last five minutes, how would you rate your productivity?
- Over the last five minutes, how would you rate your mood?
- Over the last five minutes, how would you rate your stress level?
The second phase is meant to investigate if triggering the olfactory (exposing participants to pleasant smells) senses would help reduce stress.
For that, participants will be given a task that an office worker usually conducts in their everyday work (e.g., typing a paragraph in a word document, organizing a spreadsheet) for 20 minutes. During the 20 minutes, participants will get exposed to one of the following three conditions:
- Control group - 20 participants: No exposure to smells or change in office light settings.
- Olfactory group 1 - 20 participants: No change in office light settings, but participants in this condition will be exposed to the smell of natural wood scent continuously. A diffuser with essential oils will be turned on during that time to deliver the smell.
- Olfactory group 2 - 20 participants: No change in office light settings, but participants in this condition will be exposed to the smell of Bergamot scent continuously. A diffuser with essential oils will be turned on during that time to deliver the smell.
Following this, participants will be asked to rate their anxiety/stress levels using the state anxiety trait survey and how they perceived the exposure to the scents.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
California
-
Los Angeles, California, Stati Uniti, 90089
- University of Southern California
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Participants will be older than 18.
- Participants should be proficient at speaking and writing in English.
- Qualified participants should have a normal or corrected-to-normal vision, and a normal sense of smell.
Exclusion Criteria:
- Participants will be screened to make sure that they don't have any physical or psychological-related problems that make them sensitive to stress-inducing tasks.
- Participants who are taking any medication to regulate their blood pressure will not be allowed to participate in the study as these medications might affect the quality of the blood volume pulse-related data.
- Pregnant women are not allowed to participate in this study.
- Participants using prescription medication, diagnosed with color blindness, rhinitis, or hay fever, or have allergic reactions to essential oils ( e.g., contact dermatitis, allergic rhinitis) will not be allowed to participate in this study.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione fattoriale
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Nessun intervento: Control
No exposure to smells.
|
|
Sperimentale: Olfactory Condition - 1
Participants in this condition will be exposed to the smell of natural wood scent continuously.
A diffuser with essential oils will be turned on during that time to deliver the smell.
|
Wood notes tend to be rich and warm, often forming the base of a scent due to their aromatic weight.
|
Sperimentale: Olfactory Condition - 2
Participants in this condition will be exposed to the smell of Bergamot scent continuously.
A diffuser with essential oils will be turned on during that time to deliver the smell.
|
The scent of bergamot is fruity and citrusy, with floral hints and spice notes.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Heart rate
Lasso di tempo: Throughout study participation, up to 120 minutes
|
Heart rate will be collected through a sensor attached to the participant's chest at a collection rate of 1 heart rate reading per second.
The average heart rate will be examined across study conditions.
|
Throughout study participation, up to 120 minutes
|
Electrodermal activity
Lasso di tempo: Throughout study participation, up to 120 minutes
|
Electrodermal activity will be collected through a sensor placed on the wrist similar to a watch, with data collection at a rate of 4 readings per second.
The average electrodermal activity will be examined across study conditions.
|
Throughout study participation, up to 120 minutes
|
Blink rate
Lasso di tempo: Throughout study participation, up to 120 minutes
|
A facial detection algorithm will be used to detect the blinking rate of the participant from a camera that collects 10 frames per second.
The average blink rate will be examined across study conditions.
|
Throughout study participation, up to 120 minutes
|
Gaze angle
Lasso di tempo: Throughout study participation, up to 120 minutes
|
A facial detection algorithm will be used to detect the gaze angle direction of the participant from a camera that collects 10 frames per second.
The durations of gaze angles will be examined across study conditions.
|
Throughout study participation, up to 120 minutes
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Mouse clicks
Lasso di tempo: Throughout study participation, up to 120 minutes
|
The number of mouse clicks will be recorded using a logger software installed on the computer.
The frequency of mouse clicks will be examined across study conditions.
|
Throughout study participation, up to 120 minutes
|
Keyboard keystrokes
Lasso di tempo: Throughout study participation, up to 120 minutes
|
The number of keystrokes will be recorded using a logger software installed on the computer.
The frequency of keystrokes will be examined across study conditions.
|
Throughout study participation, up to 120 minutes
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Burcin Becerik-Gerber, PhD, University of Southern California
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
Altri numeri di identificazione dello studio
- UP-21-00484
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
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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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