Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Sao Paulo | OTHER |
| Universidade do Vale do ParaÃba | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator | Is the group of subjects that will take placebo |
|
| experimental group | Experimental | Is the group of subjects that will take Bach´s Flower remedies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bach´s Flower Remedy | Other | The subjects will have 4 drops 4 times per day, for approximately 8 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Self-Reporting Questionnaire (SRQ-20) | 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). | (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. |
| Measure | Description | Time Frame |
|---|---|---|
| Spiritual Index of Well-Being Scale (SIWBS) | This instrument, translated and validated into Portuguese from the Index of Spiritual Well-Being Scale (SIWBS) is a research tool that aims to assess the influence of spiritual values in the spiritual welfare of individuals. | (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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ivan A Guerrini, PhD | Medical School of São Paulo State University (UNESP) | Study Chair |
| Ruth Turrini, PhD | Nursing School of University of São Paulo - (EEUSP) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vale do ParaÃba | São José dos Campos | São Paulo | 12244000 | Brazil |
Not provided
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D065829 | Flower Essences |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo group | Other | The subjects will have a solution non-drug type, 4 drops 4 times per day, for approximately 8 months |
|
|
| D045424 |
| Complex Mixtures |
| D004364 | Pharmaceutical Preparations |