Burnout, StudentNCT05313971
Impact of Self-awareness in Medical Students
A study testing Self knowledge course in people with Burnout, Student and Stress, Psychological, run by University of Coimbra at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Burnout, Student, Stress, Psychological, Compassion
- What is being tested?
- Self knowledge course
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Oct 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- to be a medical student enrolled in one of the several Portuguese medical schools.
Who cannot join
- not participating in 70% of the course (intervention group)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Self-awareness in Stress, Burnout, Self-compassion and Compassion in Medical Students - Controlled Clinical Trial
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.
Read the 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:
- Visual Analogue Scale for Perceived Quality of Life
- Perceived Stress Scale
- Maslach Burnout Scale for Portuguese students
- Self-Compassion Scale
- Compassion Scale
- 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.
- Conditions
- Burnout, Student, Stress, Psychological, Compassion, Self-Perception
- Being tested
- Self knowledge course
- Medical subject headings
- Burnout, Psychological, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self knowledge courseOther
The online self-knowledge and communication course, created for the purpose of this clinical trial and taught by professionals with certified training in the area by the Shalom Enneagram Institute (https://iesh.pt/), consisted of providing volunteers with mechanisms for self-knowledge using the enneagram. Three modules were carried out between October and December 2020, spaced in time to allow participants to consolidate knowledge: there was 1 month between the first and second module, and between the second and third, 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 3-week recruitment period of portuguese medical students wanting to attend the 28-hour online course Receives: Other: Self knowledge course |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
stress symptoms change
Perceived Stress Scale (PSS-10: Perceived Stress Scale; Cohen, Kamarck \& Mermelstein, 1983 (Cohen et al., 1983); Portuguese version by Trigo et al, 2010) (Trigo et al., 2010). Composed of 10 items, it allows to understand how the unpredictability, uncontrollability or excessiveness of life events are perceived as generators of stress by the individual. Each item is assigned a rating between 0 ("never") and 4 ("very often"). To calculate the final score, it is necessary to reverse the rating of items referring to positive situations (items 4, 5, 7 and 8). Thus, a result between 0 and 40 points is obtained, with values between 0 and 13 being defined as low levels of stress, 14 to 26 medium levels and 27 to 40 high levels. In the Portuguese population, the PSS-10 version has good internal consistency (α=0.87)
Measured: Change from Baseline at 2 months and 11 months
burnout risk change
Maslach Burnout Scale for Portuguese students: Its original version is, to date, the most used burnout rating scale. The version adapted for students (MBI - Student Survey), focusing on feelings and emotions in a school context, comprises 3 subscales, which assess the dimensions Emotional Exhaustion, Disbelief and Professional Effectiveness with 5, 4 and 6 items, respectively. Respondents must rate each of the 15 items between 0 ("never/never") to 6 ("always/everyday"). The final scores are interpreted in the 3 subscales, after the sum of their items, allowing the diagnosis of burnout syndrome when the respondent is simultaneously above the 66th percentile of the Emotional Exhaustion and Disbelief scores and below the 33rd percentile of the Professional Efficacy score, relative to the studied group.
Measured: Change from Baseline at 2 months and 11 months
Quality of life change percieved in visual analogue scale
Visual Analogue Scale for Perceived Quality of Life (EQ-VAS: European Quality of Life - Visual Analogue Scale; EuroQol Group, 1990; Portuguese version by Ferreira, Ferreira \& Pereira, 2014) (Ferreira et al., 2013). It is an integral part of the EuroQoL-5Dimension scale (EQ-5D), which comprises two components: a descriptive system, subdivided into 5 dimensions, and a numerical system, achieved through a visual analogue scale - the EQ-VAS thermometer. This offers the possibility for the respondent to quantify their health status on a scale from 0 ("worst imaginable health status") to 100 ("best imaginable health status"), at that moment. In the Portuguese version, the EQ-VAS showed good internal consistency (α=0.862)
Measured: Change from Baseline at 2 months and 11 months
Secondary outcomes (3)
compassion change
Compassion Scale (CS: Compassion Scale; Pommier, 2011 (Pommier, 2011); Portuguese version by Vieira, Castilho \& Duarte) (Vieira CS, 2013). Bringing together the six factors of compassion (Kindness vs. Indifference, Common Humanity vs. Disconnectedness, Mindfulness vs. Non-involvement), this scale aims to measure how each individual behaves towards others. Each subject must identify their level of agreement regarding the 24 items of the long version, on a scale from 0 ("almost never") to 5 ("almost always"). Items 1, 2, 3, 5, 7, 10 , 12, 14, 18, 19, 22 and 23, corresponding to subscales with negative connotations (Indifference, Disconnected and Non-Involvement) must be recoded to access the total compassion score. Higher scores translate to a higher level of compassion.
Measured: Change from Baseline at 2 months and 11 months
self-compassion change
Self-Compassion Scale (SELFCS: Self-Compassion Scale; Neff, 2003 (Neff, 2003); Portuguese version of Gouveia \& Castilho, 2006) (Castilho \& Gouveia, 2011). Considered the most used tool in the assessment of self-compassion, it seeks to measure how the individual behaves in difficult times, through emotional response (Warmness/Understanding vs. Self-criticism), cognitive understanding (Common Humanity vs. Isolation) and attention to one's own suffering. (Mindfulness vs. Overidentification). Each of the 26 items is assigned a rating from 0 ("almost never") to 5 ("almost always"), and it is then possible to calculate the subtotal for each of the six subscales and the total score. For this, all items are summed after recoding items 1, 2, 4, 6, 8, 11, 13, 16, 18, 20, 21, 24 and 25, with higher values reflecting higher levels of self-compassion.
Measured: Change from Baseline at 2 months and 11 months
self-reflection and insight change
Self-Reflection and Insight Scale- New Adapted and Validated Self-Awareness Measure for Brazilian Adults (SRIS: Self-Reflection and Insight Scale; Grant et al., 2002 (Grant et al., 2002); Brazilian version by DaSilveira and DeCastro, 2012) (DaSilveira et al., 2012) ). Self-response instrument with 20 items that seek to assess and measure individual differences in self-awareness, as well as intentional readiness to change behaviour. It contemplates the two-dimensionality of self-awareness through its Insight and Self-reflection subscales, which is subdivided into Need for Self-Reflection and Involvement in Self-Reflection, that is, interest vs. actual execution of the action.
Measured: Change from Baseline at 2 months and 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 Oct 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, StudentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ines Rosendo, University of Coimbra
- Investigators
- Ines Rosendo, MD PhD, Principal investigator, Assistant professor FMUC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313971
- Sponsor's protocol ID
- 096/2019
- Status last verified
- Mar 2022
- First submitted
- 18 Mar 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will not be shared because is not necessary
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Self-awareness in Stress, Burnout, Self-compassion and Compassion in Medical Students - Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05313971
- Acronym / sponsor ID
- 096/2019
- Conditions
- Burnout, Student, Stress, Psychological, Compassion, Self-Perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Visual Analogue Scale for Perceived Quality of Life
- Perceived Stress Scale
- Maslach Burnout Scale for Portuguese students
- Self-Compassion Scale
- Compassion Scale
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Self knowledge course3-week recruitment period of portuguese medical students wanting to attend the 28-hour online course |
| Control | No intervention | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- to be a medical student enrolled in one of the several Portuguese medical schools.
Key exclusion criteria (1 listed)
- not participating in 70% of the course (intervention group)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self knowledge courseThe online self-knowledge and communication course, created for the purpose of this clinical trial and taught by professionals with certified training in the area by the Shalom Enneagram Institute (https://iesh.pt/), consisted of providing volunteers with mechanisms for self-knowledge using the enneagram. Three modules were carried out between October and December 2020, spaced in time to allow participants to consolidate knowledge: there was 1 month between the first and second module, and between the second and third, 3 weeks. | Other | Intervention |
Primary outcome
stress symptoms change
Time frame: Change from Baseline at 2 months and 11 months
Perceived Stress Scale (PSS-10: Perceived Stress Scale; Cohen, Kamarck \& Mermelstein, 1983 (Cohen et al., 1983); Portuguese version by Trigo et al, 2010) (Trigo et al., 2010). Composed of 10 items, it allows to understand how the unpredictability, uncontrollability or excessiveness of life events are perceived as generators of stress by the individual. Each item is assigned a rating between 0 ("never") and 4 ("very often"). To calculate the final score, it is necessary to reverse the rating of items referring to positive situations (items 4, 5, 7 and 8). Thus, a result between 0 and 40 points is obtained, with values between 0 and 13 being defined as low levels of stress, 14 to 26 medium levels and 27 to 40 high levels. In the Portuguese population, the PSS-10 version has good internal consistency (α=0.87)
burnout risk change
Time frame: Change from Baseline at 2 months and 11 months
Maslach Burnout Scale for Portuguese students: Its original version is, to date, the most used burnout rating scale. The version adapted for students (MBI - Student Survey), focusing on feelings and emotions in a school context, comprises 3 subscales, which assess the dimensions Emotional Exhaustion, Disbelief and Professional Effectiveness with 5, 4 and 6 items, respectively. Respondents must rate each of the 15 items between 0 ("never/never") to 6 ("always/everyday"). The final scores are interpreted in the 3 subscales, after the sum of their items, allowing the diagnosis of burnout syndrome when the respondent is simultaneously above the 66th percentile of the Emotional Exhaustion and Disbelief scores and below the 33rd percentile of the Professional Efficacy score, relative to the studied group.
Quality of life change percieved in visual analogue scale
Time frame: Change from Baseline at 2 months and 11 months
Visual Analogue Scale for Perceived Quality of Life (EQ-VAS: European Quality of Life - Visual Analogue Scale; EuroQol Group, 1990; Portuguese version by Ferreira, Ferreira \& Pereira, 2014) (Ferreira et al., 2013). It is an integral part of the EuroQoL-5Dimension scale (EQ-5D), which comprises two components: a descriptive system, subdivided into 5 dimensions, and a numerical system, achieved through a visual analogue scale - the EQ-VAS thermometer. This offers the possibility for the respondent to quantify their health status on a scale from 0 ("worst imaginable health status") to 100 ("best imaginable health status"), at that moment. In the Portuguese version, the EQ-VAS showed good internal consistency (α=0.862)
3 secondary outcomes
compassion change
Time frame: Change from Baseline at 2 months and 11 months
self-compassion change
Time frame: Change from Baseline at 2 months and 11 months
self-reflection and insight change
Time frame: Change from Baseline at 2 months and 11 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No. Will not be shared because is not necessary
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ines Rosendo, MD PhD principal investigator
Assistant professor FMUC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self knowledge course in people with Burnout, Student and Stress, Psychological, run by University of Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stress symptoms change (time frame: Change from Baseline at 2 months and 11 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.