- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03895190
Effects of a Application (Flourish App) in Medical Students
Effects of a Application (Flourish App) on Stress, Well-being and Emotional Regulation in Medical Students
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
INTRODUCTION: One population that presents an important vulnerability to stress is that of university students, facing several stressors, such as academic demands, time pressure and social adjustments. Medical students in particular may face additional challenges such as heavy workload, time commitment and the number of tests and assessments as well as the pressures of a clinical setting. Some highly successful programs in stress management are based on the principle of Mindfulness. On the other hand, Positive Psychology brings a new paradigm in terms of mental and emotional health, seeking to promote human development through the development of virtues, quality of life and well-being, instead of just treating disease. In the modern world not all people are willing to attend classroom training for several reasons. In this sense, a program offered in mobile application can be considered an interesting alternative for professionals that not only want to reduce stress-related symptoms, but also promote well-being.
MAIN OBJECTIVES: Evaluate the effects of a well-being program compared to a control program, both served on mobile applications, in reducing stress, increasing well-being and improving emotional regulation in a sample of medical students.
METHOD: For this purpose, 300 students of the undergraduate medical course of Albert Einstein Israelite Faculty. Participants will be randomized into groups of 150 each, half to the control group (CG) and the other half to the intervention group (IG). The IG will participate in the Flourish App Program, for 8 weeks, while the CG will have access to a control application. Then, after the evaluations, the CG will participate in the Flourish App Program, while the first group will not participate in any intervention. Before starting the program, after 4 and 8 weeks of the program, questions will be applied to assess the stress and well-being levels of participants in general and in relation to work. In addition, before and after each training period, questions will be applied to assess the stress and well-being levels of participants at the moment. Also, the Perceived Stress Scale, the 5-item World Health Organization Well-Being Index - WHO-5, the Mindful Attention Awareness Scale, the Self-Compassion Scale and the Difficulties in Emotion Regulation Scale will be applied too. Finally, at the end of the program, the Mobile Application Rating Scale - MARS will be applied.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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SP
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São Paulo, SP, Brasilien, 05601-901
- Hospital israelita Albert Einstein
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Women and men from 17 years
- Students of the undergraduate medical course of Albert Einstein Israelite Faculty
Exclusion Criteria:
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Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: Kontrol app
I første omgang vil denne kontrolgruppe have adgang til en kontrol-app, og efter 8 uger vil denne gruppe modtage interventionen (blomstrende app-program).
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Eksperimentel: Experimental: Flourishing App Program
This group will receive the intervention Flourishing App Program and after that it will not receive any other intervention.
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Denne intervention er baseret på afslapning, velværefremme, meditationspraksis og positive psykologiske principper.
Programmet er ved at blive evalueret i et klasseværelsesformat til et andet projekt og blev tilpasset til dette projekt i applikationsformatet til mobile enheder.
Det vil vare i 8 uger, med træning på 15 til 25 minutter, fire gange om ugen.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Ændringer i subjektive symptomer på trivsel på arbejdet
Tidsramme: baseline, 4 uger, 8 uger
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Glidende skala for stressniveau fra 0 til 100
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baseline, 4 uger, 8 uger
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Ændringer i subjektive symptomer på stress
Tidsramme: baseline, 4 uger, 8 uger
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Glidende skala for velværeniveau fra 0 til 100
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baseline, 4 uger, 8 uger
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Changes in subjective symptoms of stress at the moment assessed using the sliding scale for stress
Tidsramme: four times a week, before and after the period of each class (20 minutes)
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Sliding scale for stress level from 0 to 100
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four times a week, before and after the period of each class (20 minutes)
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Changes in subjective symptoms of well-being at the moment assessed using the sliding scale for well-being
Tidsramme: four times a week, before and after the period of each class (20 minutes)
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Sliding scale for well-being level from 0 to 100
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four times a week, before and after the period of each class (20 minutes)
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Elisa H Kozasa, PhD, Instituto do Cérebro- Hospital Israelita Albert Einstein
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- HIAE_Florescer_Medicina
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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