Randomized Control Trial on Mandalas of Emotions

NCT ID: NCT04220333

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-10
• Study Completion Date: 2018-12-01

Brief 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.

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).

Conditions

Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Mandalas of Emotions

Intervention Type: BEHAVIORAL

Application of mandalas during 15 minutes

Interventions

Mandalas of Emotions

Application of mandalas during 15 minutes

Intervention Type: BEHAVIORAL

Control

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role: collaborator

University of Campinas, Brazil

OTHER

Sponsor Role: lead

Responsible Party

Gabriela Salim Spagnol

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Neuroimaging Laboratory

Campinas, São Paulo, Brazil

Countries

Brazil

Other Identifiers

64276116400005404

Identifier Type: -

Identifier Source: org_study_id