NCT05313971

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

3 months

First QC Date

March 18, 2022

Last Update Submit

March 28, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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)

    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.

    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)

    Change from Baseline at 2 months and 11 months

Secondary Outcomes (3)

  • compassion change

    Change from Baseline at 2 months and 11 months

  • self-compassion change

    Change from Baseline at 2 months and 11 months

  • self-reflection and insight change

    Change from Baseline at 2 months and 11 months

Study Arms (2)

Intervention

EXPERIMENTAL

3-week recruitment period of portuguese medical students wanting to attend the 28-hour online course

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.

Interventions

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.

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Medicina da Universidade de Coimbra

Coimbra, Portugal

Location

MeSH Terms

Conditions

Burnout, PsychologicalStress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Ines Rosendo, MD PhD

    Assistant professor FMUC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

March 18, 2022

First Posted

April 6, 2022

Study Start

October 1, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

April 6, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Will not be shared because is not necessary

Locations