Ignite Creation Date:
2024-05-06 @ 12:57 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03895190
Status:
COMPLETED
Last Update Posted:
2020-04-24
First Post:
2019-03-27
Brief Title:
Effects of a Application Flourish App in Medical Students
Sponsor:
Hospital Israelita Albert Einstein
Organization:
Hospital Israelita Albert Einstein
Study Overview
Official Title:
Effects of a Application Flourish App on Stress Well-being and Emotional Regulation in Medical Students
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None