Randomized Control Trial on Mandalas of Emotions

NCT04220333 | Completed

• 1 other identifier: 64276116400005404
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (3)

• 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.

  15 minutes

• 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.

  5 minutes

• 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.

  15 minutes

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Intervention

EXPERIMENTAL

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

Mandalas of Emotions BEHAVIORAL

Application of mandalas during 15 minutes

Intervention

Control BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Campinas, Brazil: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

Neuroimaging Laboratory

Campinas, São Paulo, 13083-878, Brazil

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: January 7, 2020
• Study Start: July 10, 2017
• Primary Completion: October 10, 2018
• Study Completion: December 1, 2018
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)