Relationship Between Treatment With Bach´s Flower Remedy and Spiritual Well-Being of People With Common Mental Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Self-Reporting Questionnaire (SRQ-20)
研究概览
简要总结
The Common Mental Disorders (CMD) refer to health states involving non-psychotic psychiatric symptoms. Part of this broad diagnostic category, symptoms such as difficulty concentrating, forgetfulness, insomnia, fatigue, irritability, feelings of worthlessness, somatic complaints, etc. The CMD has a big social impact, and its prevalence in the general population is 25% and graduate students in health care reaches 40%. The Bach´s Flower Remedies are considered a complementary therapy approved and recommended by World Health Organization and by the Brazilian Ministry of Health and in his theory it has great spiritual nature. In addition, international scientific research have suggested that the strengthening of spiritual well-being can help significantly and positively promoting mental health. This project aims to assess the relationship between treatment with Bach´s Flower Remedies and Spiritual well-being of people with Common Mental Disorders in undergraduate health students of a university located in São José dos Campos, state of São Paulo, Brazil. This research presents a quantitative and qualitative methodology, experimental clinical trial, triple blind. The treatment will take place with two groups of forty people, the group of treatment and the placebo´s. The trial will happen in six sessions at intervals of 30 days, totaling eight months of treatment. Statistical analysis will be used chi-square or Fisher exact test to study the association between the scale of spiritual well-being and the use of Bach Flowers for each time point (3 times). To compare the evolution of the results (scales) during the study will set a model for ordinal data with repeated measurements over time. For these statistical tests is assumed a significance level of 5% (p < 0.005).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People over 18 years old
- •People who have read and agreed to participate by signing an informed consent
- •People who obtain scores equal to or above 8 for women and equal to or above 6 for men in SRQ - 20
- •People who does not ingest medication
- •People who does not use any type of complementary therapy and integrative such as Herbal Medicine, Aromatherapy, Homeopathy, Flower Essences, Reiki, acupuncture, etc.
排除标准
- •Not meet the assumptions of the inclusion criteria
结局指标
主要结局
Self-Reporting Questionnaire (SRQ-20)
时间窗: (8 months) In 3 times: the first one in the first visit, the second one in the third visit and the last one in the sixth visit.
The Self-Reporting Questionnaire was developed by Harding et al. (1980), from four other instruments used for screening for possible mental disorders. The development of this instrument was coordinated by World Health Organization (WHO) and aimed to reach a possible instrument to identify cases in primary care services and community, especially in developing countries with lack of services and professionals. The intention of the WHO was to identify cases from the instrument and to encourage planners to provide services and mental health care to the needy population (WHO, 1994).
次要结局
- Spiritual Index of Well-Being Scale (SIWBS)((8 months) 3 times after the intervention: the first one in the first visit, the second one in the third visit and the last one in the sixth visit)
研究者
Ana Paula Corrêa Castello Branco Nappi Arruda
MSc, Doctoral degree
UPECLIN HC FM Botucatu Unesp