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CompletedNCT04220333MEUpdated Feb 17, 2020

Randomized Control Trial on Mandalas of Emotions

An interventional study of Mandalas of Emotions and Control in Epilepsy, sponsored by University of Campinas, Brazil. Completed at 1 site in Brazil. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-17.

Sponsored by University of Campinas, Brazil · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Jul 2017, registered Dec 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

Epilepsy is a chronic disease with a psychosocial impact on the patient. The technique called 'Mandala of Emotions' (ME), derived from the Traditional Chinese Medicine, facilitates expression and awareness of emotions. In our pilot case study, the group "intervention with ME" managed to arouse their emotions and after the intervention felt lighter and relaxed at a higher frequency than the control group. We conducted a blind case control study to further assess usefulness of ME. Materials and Methods: Patients and caregivers recruited at an Epilepsy Outpatients Clinic with the approval of Ethics Committee were randomly divided into groups 'Control' (n=57) and 'Intervention' (n=53). In the ME group, five colored stones (green, red, yellow, white and black) were applied according to the emotion chosen by the participant. Individual assessment performed blinded to who received intervention applied a structured questionnaire and Likert-scales about the degree of relaxation and feelings pre- and post-experiment.

Read the detailed description

Patients and caregivers were recruited at an Epilepsy Outpatients Clinic. This study has approval of local Ethics Committee. Participants were invited to this research at the Outpatient clinic waiting room, and when they expressed interest, they were referred to the research team. Inclusion criteria for this study were: men and women treated in the epilepsy outpatient clinic, aged 18-60 years. Volunteers signed the informed consent to participate in the study, answered a questionnaire with information about demographics, epilepsy history (age of onset, frequency, last seizure, medications). They described their emotional characteristics (intuitive, emotive, and rational) and how they felt at that moment. They were invited to choose an emotion from a list (Concern/obsession, Anger/irritation, Fear, Compassion, Sadness, Comprehension, Euphoria, Gratitude, Joy, Peace) to work on during the intervention. After, they were randomly divided into two groups: 'Control' and 'Intervention' (see Figure 1).

The Mandalas of Emotions refers to five colors in accordance to the five stages or seasons (spring, summer, high summer, fall, winter). These establish a relation to the five functional systems (liver, heart, spleen and pancreas, lungs and kidney), and to five emotions (anger, joy/euphoria, concern/obsession, sadness/melancholy, fear) with its opposite correspondents (understanding, compassion, gratitude, enthusiasm, harmony) (Ling, 2013).

Figure 1. Research procedures.

The team, composed of five researchers, was divided in two groups: three researchers performed the interview before and after the intervention, two others applied the intervention, which divided participants in two groups: "control" and "intervention", assuming the confidentiality of this classification, as expected in a randomized, case control, blind assessment of outcome study.

Both groups received the same initial recommendations: 'please, lie down, relax and pay attention to your breath'. The total procedure time was the same for both groups.

The intervention protocol was divided in two steps: first, patients spent 5 minutes in the phase of harmonization with five colored stones of a size of a walnut (green, red, yellow, white and black) placed around their bodies.

Second, in accordance to the emotion chosen by the participant, a matching mandala was placed next to the feet, on the abdomen, or next to the head depending on the self-perceived personality type, intuitive, emotive and rational for the remaining 10 minutes. The researcher also checked the control subjects once during the 15 fifteen minutes of experiment.

Soon after the experiment, individual assessment was performed blinded to who received intervention using a structured questionnaire and Likert-scales about the degree of relaxation and feelings.

Statistical analysis We first divided the groups and analyzed whether they differed in regard to sex, age, years of schooling, age of onset of seizures, time of last seizure, frequency of seizures per month, use of monotherapy and seizure control. Statistical analysis was conducted with SPSS using non-parametric tests (Mann-Whitney, ANOVA for repeated measures) and Chi-square. Content of patients perceptions were analyzed according to themes and compared between groups (control vs. intervention).

02

Conditions studied

  • Epilepsy

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03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 110 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.

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Lead sponsor

University of Campinas, Brazil is the lead sponsor of 166 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • men and women treated in the epilepsy outpatient clinic, aged 18-60 years. Volunteers signed the informed consent to participate in the study, answered a questionnaire with information about demographics, epilepsy history (age of onset, frequency, last seizure, medications).

Exclusion criteria

Exclusion Criteria:

  • Associated clinical conditions that prevented full comprehension of research procedures.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
110 participants (actual)

Study arms

  • Placebo comparator
    Control

    Participants received the instruction: 'please, lie down, relax and pay attention to your breath'. This procedure was carried during 15 minutes. Soon after the experiment, individual assessment was performed blinded to who received intervention using a structured questionnaire and Likert-scales about the degree of relaxation and feelings.

    Behavioral: Control

  • Experimental
    Intervention

    The intervention protocol was divided in two steps: first, patients spent 5 minutes in the phase of harmonization with five colored stones of a size of a walnut (green, red, yellow, white and black) placed around their bodies. Second, in accordance to the emotion chosen by the participant, a matching mandala was placed next to the feet, on the abdomen, or next to the head depending on the self-perceived personality type, intuitive, emotive and rational for the remaining 10 minutes (Figure 3B). The researcher also checked the control subjects once during the 15 fifteen minutes of experiment. Soon after the experiment, individual assessment was performed blinded to who received intervention using a structured questionnaire and Likert-scales about the degree of relaxation and feelings.

    Behavioral: Mandalas of Emotions

Interventions

  • BehavioralMandalas of Emotions

    Application of mandalas during 15 minutes

  • BehavioralControl

    Participants were requested to "lie down, relax and pay attention to your breath".

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What researchers measure

Primary outcomes

  1. Pre procedure Likert scale report

    Before the procedure, researchers asked "How are you feeling?" and participants replied in a Likert scale from 1-Very bad to 5-Very good.

    Time frame: 15 minutes

  2. Perception of changes after 5 min of procedure

    Five minutes after the procedure began, researchers applied the question: "How are you feeling?" and the researcher registered as they reported physical and emotional changes. No further measures or questionnaires were applied at this point.

    Time frame: 5 minutes

  3. Post procedure Likert scale report and qualitative questions

    After the procedure, researchers asked "How are you feeling?" and participants replied in a Likert scale from 1-Very bad to 5-Very good. Researchers also applied a questionnaire with these questions: "Did you experience body changes / retrieval of memories / retrieval of specific images? Do you have any observations regarding the procedure? Researchers registered yes/no reply and participants description of changes. No further measures or questionnaires were applied after this procedure.

    Time frame: 15 minutes

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Study locations

1 site
  • Neuroimaging Laboratory
    Campinas, SP 13083-878, Brazil
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References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04220333
Lead sponsor
University of Campinas, Brazil
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Responsible party
Gabriela Salim Spagnol (Principal Investigator, University of Campinas, Brazil) — Principal investigator
First posted
Jan 7, 2020
Start date
Jul 10, 2017
Primary completion
Oct 10, 2018
Completion
Dec 1, 2018
Last update
Feb 17, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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