Effects of a Application (Flourish App) in Medical Students

Emotional Stress Clinical Trial

Official title:

Effects of a Application (Flourish App) on Stress, Well-being and Emotional Regulation in Medical Students

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03895190
• Other study ID #: HIAE_Florescer_Medicina
• Status: Completed
• Phase: N/A
• Start date: August 6, 2019
• Est. completion date: April 21, 2020

Study information

• Verified date: March 2019
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This protocol proposes a well-being program, delivered through an application for mobile devices, based on meditation and positive psychology principles such as human development, the improvement of virtues, quality of life and well-being. The investigators hypothesize that this program offered in mobile application may promote well-being, reduce stress related problems and improving emotional regulation in the participants. Objectives: To evaluate the effectiveness of a well-being program delivered through an application for mobile devices in a sample of medical students. Methods: Three hundred students of the undergraduate medical course of Albert Einstein Israelite Faculty will be recruited. The participants will be randomized in two groups of 150 participants each one, half of them in the control group (GC) and the other half to the intervention group (GI).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 21, 2020
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• Women and men from 17 years

• Students of the undergraduate medical course of Albert Einstein Israelite Faculty

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Emotional Stress
• Stress, Psychological

Intervention

Behavioral:
• Flourishing App Program
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.

Locations

Country	Name	City	State
Brazil	Hospital Israelita Albert Einstein	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in subjective symptoms of well-being at work	Sliding scale for stress level from 0 to 100	baseline, 4 weeks, 8 weeks
Primary	Changes in subjective symptoms of stress	Sliding scale for well-being level from 0 to 100	baseline, 4 weeks, 8 weeks
Secondary	Changes in subjective symptoms of stress at the moment assessed using the sliding scale for stress	Sliding scale for stress level from 0 to 100	four times a week, before and after the period of each class (20 minutes)
Secondary	Changes in subjective symptoms of well-being at the moment assessed using the sliding scale for well-being	Sliding scale for well-being level from 0 to 100	four times a week, before and after the period of each class (20 minutes)