Randomized Control Trial on Mandalas of Emotions
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional

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).
    

Intervention name(s): Mandalas of Emotions; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Application of mandalas during 15 minutes; Participants were requested to "lie down, relax and pay attention to your breath".
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Single (Investigator)
Primary purpose: Treatment