Depression Clinical Trial
Official title:
Effects of Complementary Spirit Therapy on Servers and Patients
Background: Complementary Spiritist Therapy (ECT) based on a range of therapeutic resources
including prayer, spiritist "passe", fluidotherapy (fluidic water or magnetized water),
spirit education. The aim of this study was to evaluate the effects of ECT in individuals at
UFTM Hospital de Clínicas.
Methods: Randomized controlled trial, patients were randomly. Patients will then be allocated
into groups:
- The group submitted to ECT (prayer, spiritual education, spiritist "passe" and fluidized
water or prayer or spiritist "passe" or laying on of hands with intent to heal or laying
on of hands with intent to heal or fluidized water or no-fluidized water or Control
group (CG) will not be submitted to any intervention.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | December 30, 2025 |
Est. primary completion date | April 9, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - The patients with the ability to understand the questionnaires. Exclusion Criteria: - Patients expected to be discharged in less than 4 days - Lowering the level of consciousness. |
Country | Name | City | State |
---|---|---|---|
Brazil | Élida Mara Carneiro | Uberaba | Minas Gerais |
Lead Sponsor | Collaborator |
---|---|
Universidade Federal do Triangulo Mineiro |
Brazil,
Carneiro ÉM, Barbosa LP, Marson JM, Terra JA Junior, Martins CJ, Modesto D, Resende LA, Borges MF. Effectiveness of Spiritist "passe" (Spiritual healing) for anxiety levels, depression, pain, muscle tension, well-being, and physiological parameters in car — View Citation
Carneiro ÉM, Moraes GV, Terra GA. Effectiveness of Spiritist Passe (Spiritual Healing) on the Psychophysiological Parameters in Hospitalized Patients. Adv Mind Body Med. 2016 Summer;30(3):4-10. — View Citation
de Souza Cavalcante R, Banin VB, de Moura Ribeiro Paula NA, Daher SR, Habermann MC, Habermann F, Bravin AM, da Silva CE, de Andrade LG. Effect of the Spiritist "passe" energy therapy in reducing anxiety in volunteers: A randomized controlled trial. Complement Ther Med. 2016 Aug;27:18-24. doi: 10.1016/j.ctim.2016.05.002. Epub 2016 May 6. — View Citation
Lucchetti G, de Oliveira RF, Gonçalves JP, Ueda SM, Mimica LM, Lucchetti AL. Effect of Spiritist "passe" (Spiritual healing) on growth of bacterial cultures. Complement Ther Med. 2013 Dec;21(6):627-32. doi: 10.1016/j.ctim.2013.08.012. Epub 2013 Aug 31. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Anxiety sympton. | The Depression Anxiety and Stress Scale (DASS-21). This scale is a Likert 4-point scale between 0 (not applicable to me) and 3 (applies to me a lot, or most of the time). Scores for depression, anxiety and stress are determined by summing the scores of the 21 items. | The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths. | |
Secondary | change in Depression. | The HAD subscale. Each of your items can be punctuated with zero to three, composing a maximum score of 21 points for each scale. | The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths. | |
Secondary | Change in Depression sympton. | The Depression Anxiety and Stress Scale (DASS-21). This scale is a Likert 4-point scale between 0 (not applicable to me) and 3 (applies to me a lot, or most of the time). Scores for depression, anxiety and stress are determined by summing the scores of the 21 items. | The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths. | |
Secondary | Change in Tension muscle. | The visual analog scale of tension muscle. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom) orientated from the left (worst) to the right (best). | The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths. | |
Secondary | Change in wellness subjective. | The wellness subjective scale. This scale is is composed of 21 items of evaluation of positive affect, 26 items of negative affect and satisfaction with life consists of 15 items. | The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths. | |
Secondary | Change in wellness. | The visual analog scale of wellness. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom) orientated from the left (worst) to the right (best). | The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths. | |
Secondary | Change in hematological and immunological responses. | Hemogram, immunoglobulin A , cortisol and Cytokine Doses. | The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths. | |
Secondary | Change in pain. | The visual analog scale of Pain. The most simple Visual Analog Pain Scale is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom) orientated from the left (worst) to the right (best). | The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths. | |
Secondary | Change in blood pressure | Blood pressure (mmHg) is assessed by blood pressure gauge. | The blood pressure will be evaluated an average on 1 day, 3 days, 1 week, 15 days, 2 mounths. | |
Secondary | Change in respiratory rate | Respiratory (ipm) rate is assessed by manual count. | The respiratory rate will be evaluated an average on 1 day, 3 days, 1 week, 15 days, 2 mounths. | |
Secondary | Change in cardiac rate | Cardiac rate (bpm) is assessed by oximeter More Fitness. | The cardiac rate will be evaluated an average on 1 day, 3 days, 1 week, 15 days, 2 mounths. | |
Secondary | Change in oxygen saturation | oxygen saturation (%) is assessed by oximeter More Fitness. | The oxygen saturation will be evaluated an average on 1 day, 3 days, 1 week, 15 days, 2 mounths. | |
Secondary | Change in Heart rate variability | Heart rate variability. It is measured by electrocardiogram (ECG) or frequency meter | The heart rate variability will be assessed on 1 day. | |
Secondary | Change in Burnout. | Maslach Burnout Inventory. The instrument consists of 15 questions that are subdivided into three subscales: Emotional Exhaustion (EE) (5 items); Disbelief (DE) (4 items) and Professional Efficacy (EP) (6 items). All items are evaluated on a 7-point Likert scale, ranging from 0 (never) to 6 (always). | The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths. | |
Secondary | Change in Quality of life | Whoqol. The instrument module consists of 26 questions (being question number 1 and 2 on general quality of life), the answers follow a Likert scale (from 1 to 5, the higher the score the better the quality of life). Apart from these two questions (1 and 2), the instrument has 24 facets which comprise 4 domains that are: PHYSICAL, PSYCHOLOGICAL, SOCIAL RELATIONS and ENVIRONMENT. | The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths. | |
Secondary | Change in Stress score. | The scale of stress. This assessment is a questionnaire that evaluates stress in four levels - alert, resistance, almost exhaustion and exhaustion. The instrument assesses the presence of symptoms and how the individual has felt in the last 24 h, in the last month and in the last 3 months. For each period of time, a set of 15 physical and emotional symptoms is evaluated for the first 2 periods and 23 symptoms are evaluated for the last period. | The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths. | |
Secondary | Change in Stress. | The Depression Anxiety and Stress Scale (DASS-21). This scale is a Likert 4-point scale between 0 (not applicable to me) and 3 (applies to me a lot, or most of the time). Scores for depression, anxiety and stress are determined by summing the scores of the 21 items. | The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths. | |
Secondary | Change in perceived anxiety. | Visual analog scale. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom) orientated from the left (worst) to the right (best). | The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths. | |
Secondary | Change in Anxiety. | The Hospital Anxiety and Depression Scale. It has 14 items, seven of which are for evaluation of anxiety (HADS-A) and seven for depression (HADS-D). Each of your items can be punctuated with zero to three, composing a maximum score of 21 points for each scale. | The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths. |
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