PersonalityNCT04698811
Virtual Eneagram: Quality of Life, Stress and Anxiety.
A study testing VIRTUAL ENEAGRAM in people with Personality, run by Universidade do Vale do Sapucai at 1 site in Brazil.
Trial summary
The objetictive is to observe the influence of the enneagram typology on the perception of anxiety, stress and quality of life through self-knowledge directed in a virtual learning environment. The study is a clinical, primary, analytical, prospective and longitudinal study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Personality
- What is being tested?
- VIRTUAL ENEAGRAM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteBrazil
- Study dates
- 18 Nov 2020to 5 Apr 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals of both sexes, Brazilians, adults, over 18 years old.
- Individuals who accept to sign the Informed Consent Form;
- Individuals with a desire to achieve self-awareness with the availability of time and access to the internet to hold meetings;
Who cannot join
- Individuals who drop out of work at any time;
- Individuals who have missed the modules and do not make a subsequent replacement;
Trial locations and contacts
1 site in 1 country.
About this study
The objetictive is to observe the influence of the enneagram typology on the perception of anxiety, stress and quality of life through self-knowledge directed in a virtual learning environment. The study is a clinical, primary, analytical, prospective and longitudinal study. It will be carried out in a virtual learning environment (VLE) with the collection of data obtained before and after the beginning of the training on the enneagram. The training will be divided into three online AVA modules. Casuistry: after orientations and signature of the term (Informed Consent Form), they will register on social networks where the initial information will be filled out. to outline the group. Inclusion criteria: participants of both sexes, Brazilians, over 18 years old; agree to sign the Informed Consent Form; with the desire to realize self-knowledge with the availability of time and access to the internet to hold meetings; Non-inclusion criteria: do not have previous information about the enneagram and speak the Portuguese language; Exclusion criteria: participation in work at any time; Individuals who have missed the modules and do not do the replacement later. Instruments: World Health Organization Quality of Life - (WHOQOL-BREF). Stress Perception Scale 10 (EPS-10) The Trait-State Anxiety Inventory: STAI E and T.
Read the detailed description
INTRODUCTION - Personality is the set of characteristics that define the individual's behavior, his relationship with the external world and his way of reacting to the events that occur in it. Personality is closely related to the development of pathological processes, the integrity of your biological tissues and the repercussions that this can cause in your lives. In addition, there is a relationship with levels of anxiety, stress and quality of life. The enneagram is a tool that groups personalities into nine types, identifies their functioning patterns and reaction mechanisms. The use is quite widespread today, but still in an empirical way, requiring a greater scientific basis. OBJECTIVE - to observe the influence of the enneagram typology on the perception of anxiety, stress and quality of life through self-knowledge directed in a virtual learning environment. METHODS: clinical, primary, analytical, prospective and longitudinal study. It will be carried out in a virtual learning environment (VLE) with the collection of data obtained before and after the beginning of the training on the enneagram. The training will be divided into three online AVA modules. Casuistry: after orientations and signature of the term (Informed Consent Form), they will register on social networks where the initial information will be filled out. to outline the group. Inclusion criteria: participants of both sexes, Brazilians, over 18 years old; agree to sign the Informed Consent Form; with the desire to realize self-knowledge with the availability of time and access to the internet to hold meetings; Non-inclusion criteria: do not have previous information about the enneagram and speak the Portuguese language; Exclusion criteria: participation in work at any time; Individuals who have missed the modules and do not do the replacement later. Instruments: World Health Organization Quality of Life - (WHOQOL-BREF). Stress Perception Scale 10 (EPS-10) The Trait-State Anxiety Inventory: STAI E and T. After the guidance and signature of the ICF, the Organizational Learning Structure will be presented Statistical Analysis: The data will be tabulated in Microsoft Excel 2016 and measures will be used central tendency for quantitative variables and absolute and relative frequency for categorical variables. Pearson's correlation analysis; multiple regression analysis and Wilcoxon test. The product resulting from this work will be the Enneagram Online Teaching and Research System (Sep9). KEYWORDS: Personality. Anxiety. Quality of Life. Stress, Psychological. Personality Tests.
- Conditions
- Personality
- Being tested
- VIRTUAL ENEAGRAM
- Keywords
- Personality. ., Anxiety, Quality of Life., Stress, Psychological., Personality Tests.
- Medical subject headings
- Anxiety Disorders, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIRTUAL ENEAGRAMBehavioural
Presentation of the Virtual Enneagram and its content and realization of the first battery of tests (World Health Organization Quality of Life - (WHOQOL-BREF). Stress Perception Scale 10 (EPS-10) The Trait-State Anxiety Inventory: IDATE E and T.) .
Guidance and training on personality and the Enneagram, its classification system, personality subtypes and dynamics of stress and growth allowing self-recognition.
Second test battery ((World Health Organization Quality of Life - (WHOQOL-BREF). Stress Perception Scale 10 (EPS-10) The Trait-State Anxiety Inventory: (IDATE E and T.) and Enneagram Questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| VIRTUAL ENEAGRAM: QUALITY OF LIFE, STRESS AND ANXIETY. | Other | Training and testing battery. Receives: Behavioral: VIRTUAL ENEAGRAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the condition of anxiety, stress and quality of life of the participating individuals.
The data it will be tabulated in Microsoft Excel 2016 and submitted to statistical analysis, measures of central tendency were used for quantitative variables and absolute and relative frequency for categorical variables. The Minitabversion 18.1 program and the Statistical Package for the Social Sciences, Inc. (SPSS) Chicago, USA, version 22.0, were used. The level of significance used as a criterion for acceptance or rejection in the statistical tests was 5% (p <0.05).
Measured: Up to 24 weeks
Secondary outcomes (1)
Analysis of the condition of anxiety, stress and quality of life of the participating after intervention with a virtual enneagram; .
The data were tabulated in Microsoft Excel 2016 and submitted to statistical analysis, measures of central tendency were used for quantitative variables and absolute and relative frequency for categorical variables. The Minitabversion 18.1 program and the Statistical Package for the Social Sciences, Inc. (SPSS) Chicago, USA, version 22.0, were used. The level of significance used as a criterion for acceptance or rejection in the statistical tests was 5% (p <0.05).
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start18 Nov 2020
- Primary completion5 Feb 2021
- Study completion5 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PersonalityStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will be invited to the activities through the publication of registration on social networks. After reading and accepting the informed consent form, the initial information for the design of the group will be filled out. The activities will be applied to a minimum group of 135 people. If the number of registrants qualified for the study does not reach 135 individuals, the registration period will be extended by 15 days in order to complete the sample. Still being insufficient, the test will be carried out with the sample found.
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Sapucai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Dias da Silva Neto, Universidade do Vale do Sapucai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698811
- Sponsor's protocol ID
- Fundação de Ensino Superior
- Status last verified
- Oct 2021
- First submitted
- 30 Dec 2020
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available for download on the teaching platform.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Eneagram: Quality of Life, Stress and Anxiety.
- ClinicalTrials.gov ID
- NCT04698811
- Acronym / sponsor ID
- Fundação de Ensino Superior
- Conditions
- Personality
- Keywords
- Personality. ., Anxiety, Quality of Life., Stress, Psychological., Personality Tests.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Universidade do Vale do SapucaiUniversity, hospital or other
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 5 Apr 2021 (actual)
- First posted
- 7 Jan 2021 (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.
The objetictive is to observe the influence of the enneagram typology on the perception of anxiety, stress and quality of life through self-knowledge directed in a virtual learning environment. The study is a clinical, primary, analytical, prospective and longitudinal study. It will be carried out in a virtual learning environment (VLE) with the collection of data obtained before and after the beginning of the training on the enneagram. The training will be divided into three online AVA modules. Casuistry: after orientations and signature of the term (Informed Consent Form), they will register on social networks where the initial information will be filled out. to outline the group. Inclusion criteria: participants of both sexes, Brazilians, over 18 years old; agree to sign the Informed Consent Form; with the desire to realize self-knowledge with the availability of time and access to the internet to hold meetings; Non-inclusion criteria: do not have previous information about the enneagram and speak the Portuguese language; Exclusion criteria: participation in work at any time; Individuals who have missed the modules and do not do the replacement later. Instruments: World Health Organization Quality of Life - (WHOQOL-BREF). Stress Perception Scale 10 (EPS-10) The Trait-State Anxiety Inventory: STAI E and T.
Detailed description
INTRODUCTION - Personality is the set of characteristics that define the individual's behavior, his relationship with the external world and his way of reacting to the events that occur in it. Personality is closely related to the development of pathological processes, the integrity of your biological tissues and the repercussions that this can cause in your lives. In addition, there is a relationship with levels of anxiety, stress and quality of life. The enneagram is a tool that groups personalities into nine types, identifies their functioning patterns and reaction mechanisms. The use is quite widespread today, but still in an empirical way, requiring a greater scientific basis. OBJECTIVE - to observe the influence of the enneagram typology on the perception of anxiety, stress and quality of life through self-knowledge directed in a virtual learning environment. METHODS: clinical, primary, analytical, prospective and longitudinal study. It will be carried out in a virtual learning environment (VLE) with the collection of data obtained before and after the beginning of the training on the enneagram. The training will be divided into three online AVA modules. Casuistry: after orientations and signature of the term (Informed Consent Form), they will register on social networks where the initial information will be filled out. to outline the group. Inclusion criteria: participants of both sexes, Brazilians, over 18 years old; agree to sign the Informed Consent Form; with the desire to realize self-knowledge with the availability of time and access to the internet to hold meetings; Non-inclusion criteria: do not have previous information about the enneagram and speak the Portuguese language; Exclusion criteria: participation in work at any time; Individuals who have missed the modules and do not do the replacement later. Instruments: World Health Organization Quality of Life - (WHOQOL-BREF). Stress Perception Scale 10 (EPS-10) The Trait-State Anxiety Inventory: STAI E and T. After the guidance and signature of the ICF, the Organizational Learning Structure will be presented Statistical Analysis: The data will be tabulated in Microsoft Excel 2016 and measures will be used central tendency for quantitative variables and absolute and relative frequency for categorical variables. Pearson's correlation analysis; multiple regression analysis and Wilcoxon test. The product resulting from this work will be the Enneagram Online Teaching and Research System (Sep9). KEYWORDS: Personality. Anxiety. Quality of Life. Stress, Psychological. Personality Tests.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be invited to the activities through the publication of registration on social networks. After reading and accepting the informed consent form, the initial information for the design of the group will be filled out. The activities will be applied to a minimum group of 135 people. If the number of registrants qualified for the study does not reach 135 individuals, the registration period will be extended by 15 days in order to complete the sample. Still being insufficient, the test will be carried out with the sample found.
| Arm | Type | Receives |
|---|---|---|
| VIRTUAL ENEAGRAM: QUALITY OF LIFE, STRESS AND ANXIETY. | Other | Behavioral: VIRTUAL ENEAGRAMTraining and testing battery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals of both sexes, Brazilians, adults, over 18 years old.
- Individuals who accept to sign the Informed Consent Form;
- Individuals with a desire to achieve self-awareness with the availability of time and access to the internet to hold meetings;
Key exclusion criteria (2 listed)
- Individuals who drop out of work at any time;
- Individuals who have missed the modules and do not make a subsequent replacement;
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 |
|---|---|---|
| VIRTUAL ENEAGRAMPresentation of the Virtual Enneagram and its content and realization of the first battery of tests (World Health Organization Quality of Life - (WHOQOL-BREF). Stress Perception Scale 10 (EPS-10) The Trait-State Anxiety Inventory: IDATE E and T.) . Guidance and training on personality and the Enneagram, its classification system, personality subtypes and dynamics of stress and growth allowing self-recognition. Second test battery ((World Health Organization Quality of Life - (WHOQOL-BREF). Stress Perception Scale 10 (EPS-10) The Trait-State Anxiety Inventory: (IDATE E and T.) and Enneagram Questionnaire. | Behavioural | VIRTUAL ENEAGRAM: QUALITY OF LIFE, STRESS AND ANXIETY. |
Primary outcome
Analysis of the condition of anxiety, stress and quality of life of the participating individuals.
Time frame: Up to 24 weeks
The data it will be tabulated in Microsoft Excel 2016 and submitted to statistical analysis, measures of central tendency were used for quantitative variables and absolute and relative frequency for categorical variables. The Minitabversion 18.1 program and the Statistical Package for the Social Sciences, Inc. (SPSS) Chicago, USA, version 22.0, were used. The level of significance used as a criterion for acceptance or rejection in the statistical tests was 5% (p <0.05).
1 secondary outcome
Analysis of the condition of anxiety, stress and quality of life of the participating after intervention with a virtual enneagram; .
Time frame: through study completion, an average of 6 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 14 Oct 2021.
- Individual participant dataSharing planned: Yes. The data will be available for download on the teaching platform.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIRTUAL ENEAGRAM in people with Personality, run by Universidade do Vale do Sapucai at 1 site in Brazil.
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 3 inclusion and 2 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 14 Oct 2021. 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 Brazil. 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?
Analysis of the condition of anxiety, stress and quality of life of the participating individuals. (time frame: Up to 24 weeks). 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 14 Oct 2021.