Clinical trial NCT05313971: Impact of Self-awareness in Medical Students
Official title: Impact of Self-awareness in Stress, Burnout, Self-compassion and Compassion in Medical Students - Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout, Student
Stress, Psychological
Compassion
Self-Perception
Lead sponsor: University of Coimbra
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After the recruitment period, of the 27 initially enrolled, 24 attended more than 70% of a 28-hour online course, forming the intervention group. The control group was recruited in order to match the age, gender, academic year and teaching faculty variables with the intervention group and people with these characteristics were invited to participate.
Primary purpose: OTHER

Brief summary: Objectives: The goal of this study is to understand whether self-knowledge, using the Enneagram, has a long-term impact as a modifying factor of the quality of life, self-compassion and compassion of medical students.

Methods: An initial sample of 48 medical students answered, before, immediately after and 9 months after an intervention, an online questionnaire with 6 scales. The intervention group took a self-knowledge and communication course based on the Enneagram. The control group was recruited by matching the sociodemographic variables with the intervention group. The data obtained was subject to descriptive and inferential statistical analysis and qualitative content analysis.

Detailed description: Study design Longitudinal study of intervention, controlled, with a reassessment 9 months after the intervention.

Selection of participants The process of recruiting participants involved an online dissemination of the study made by students from the Portuguese Faculties of Medicine of the Universities of Coimbra, Minho, Porto and Lisbon. Interested parties signed up on a Google Form, where the conditions of participation were detailed. The only defined inclusion criterion was to be a medical student enrolled in one of the several Portuguese medical schools.

In order to understand the necessary sample size, the significant results obtained on the Burnout scale of a previous pilot study were used as a basis. The average and the standard deviation obtained before the course and the average achieved after the course of the 3 dimensions of the Burnout scale were inserted into a necessary sample calculation formula, for an alpha of 0.05 and power (1-ß) of 80% (Sample Size Calculator: https://clincalc.com/stats/samplesize.aspx.). We therefore set a target of at least 24 participants needed to form the intervention group.

Data collection Data collection was carried out by filling out a questionnaire on Google Forms lasting about 20 minutes. This collection took place in three stages: both intervention and control groups completed the questionnaire for the first time immediately before the beginning of the first session of the course (phase 1), having repeated it after the conclusion of the third module (phase 2) and again 9 months later (phase 3).

The questionnaire was divided into two distinct parts: the first had the coding of each volunteer for later comparison of data, ensuring their confidentiality, which was followed by the collection of sociodemographic variables: gender, age, academic year and educational institution. The second part was intended to collect the variables of the measured dimensions (perceived quality of life, perceived stress, burnout, self-compassion, compassion and self-reflection and insight), through the application of 6 scales:

1. Visual Analogue Scale for Perceived Quality of Life
2. Perceived Stress Scale
3. Maslach Burnout Scale for Portuguese students
4. Self-Compassion Scale
5. Compassion Scale
6. Self-Reflection and Insight Scale- New Adapted and Validated Self-Awareness Measure for Brazilian Adults In the questionnaires of phases 2 and 3, a last open-response question was added so that the intervention group could share the benefits, in personal terms, in the management of stress and in the relationship and communication with others, which they thought they had acquired with the course.

Eligibility criteria: Inclusion Criteria:

* to be a medical student enrolled in one of the several Portuguese medical schools.

Exclusion criteria:

- not participating in 70% of the course (intervention group)

Primary outcomes:
measure: stress symptoms change
timeFrame: Change from Baseline at 2 months and 11 months
measure: burnout risk change
timeFrame: Change from Baseline at 2 months and 11 months
measure: Quality of life change percieved in visual analogue scale
timeFrame: Change from Baseline at 2 months and 11 months
Secondary outcomes:
measure: compassion change
timeFrame: Change from Baseline at 2 months and 11 months
measure: self-compassion change
timeFrame: Change from Baseline at 2 months and 11 months
measure: self-reflection and insight change
timeFrame: Change from Baseline at 2 months and 11 months
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Faculdade de Medicina da Universidade de Coimbra
Study officials:
affiliation: Assistant professor FMUC
name: Ines Rosendo, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: