Randomized Control Trial on Mandalas of Emotions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Pre procedure Likert scale report
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •Associated clinical conditions that prevented full comprehension of research procedures.
结局指标
主要结局
Pre procedure Likert scale report
时间窗: 15 minutes
Before the procedure, researchers asked "How are you feeling?" and participants replied in a Likert scale from 1-Very bad to 5-Very good.
Post procedure Likert scale report and qualitative questions
时间窗: 15 minutes
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.
Perception of changes after 5 min of procedure
时间窗: 5 minutes
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.
次要结局
未报告次要终点
研究者
Gabriela Salim Spagnol
Principal Investigator
University of Campinas, Brazil