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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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SP
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São Paulo, SP, Brazil, 05601-901
- Hospital Israelita Albert Einstein
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Control App
Initially this control group will have access to a Control App and after 8 weeks this goup will receive the intervention (Flourishing App Program).
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Experimental: 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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This intervention is based on relaxation, well-being promotion, meditation practices and positive psychology principles.
The program is being evaluated in a classroom format into another project and was adapted for this project in the application format for mobile devices.
It will last for 8 weeks, with trainings of 15 to 25 minutes, four times a week.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in subjective symptoms of well-being at work
Time Frame: baseline, 4 weeks, 8 weeks
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Sliding scale for stress level from 0 to 100
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baseline, 4 weeks, 8 weeks
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Changes in subjective symptoms of stress
Time Frame: baseline, 4 weeks, 8 weeks
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Sliding scale for well-being level from 0 to 100
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baseline, 4 weeks, 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in subjective symptoms of stress at the moment assessed using the sliding scale for stress
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Investigators
- Principal Investigator: Elisa H Kozasa, PhD, Instituto do Cérebro- Hospital Israelita Albert Einstein
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HIAE_Florescer_Medicina
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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