Evaluation of Integrative and Complementary Practices in Health (PICS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Depression
研究概览
简要总结
Complementary medicine, considered an unconventional approach, is performed in conjunction with conventional medicine. In Brazil, Integrative and Complementary Practices in Health have been inserted by the National Ordinance of Integrative and Complementary Practices. The aim of this study is to evaluate the effects of laying on of hands with spiritual connection by the Spiritist Passe about mental and physical health and quality of life of individuals.
详细描述
Type of study: randomized controlled trial. The sample will consist of cancer and epileptic patients including individuals aged eigtheen years and over. Patients will be referred by health professionals and social workers from Lar da Charidade, Clinics Hospital and attachments, as well as from the general community and will be invited to participate in the study at the Center for Integrative and Complementary Practices of the Clinics Hospital.
Participants will answer the questionnaires before the start of the study, after eight sessions and fiveteen days or the end of the research according to the group. The participants will be submitted to blood collection, when necessary.
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, Investigator, Outcomes Assessor)
盲法说明
The investigators and outcome evaluators will be blind to interventions that participants receive (do not know participants' allocation) and participants will be blind to subgroups without laying on of hands, laying on of hands with and without Spiritual connection (Spirit "passe"), not knowing which group they were allocated to.
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
- •Cancer patients: diagnosis of neoplasia receiving parenteral chemotherapy.
- •Epileptic patients: clinical diagnosis of focal epilepsy
排除标准
- •Cancer patients: pregnant women, unable to understand the questionnaires; non-attendance of 3 sessions of therapy application and refusal to sign the consent form.
- •Epileptic patients: people unable to understand the questionnaires; non-attendance of 3 sessions of therapy application and refusal to sign the consent form, as well as special groups (pregnant women, newly diagnosed epilepsy).
结局指标
主要结局
Depression
时间窗: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Evaluation of Depression by by Depression, Anxiety and Stress Scale. Scores between 0-63. Higher score indicates greater severity.
Anxiety
时间窗: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Evaluation of Anxiety by Depression, Anxiety and Stress Scale. Scores between 0-63. Higher score indicates greater severity.
Stress
时间窗: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Evaluation of stress by Depression, Anxiety and Stress Scale. Scores between 0-63. Higher score indicates greater severity.
次要结局
- Fatigue cancer patients(Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.)
- Quality of life in cancer patients(Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.)
- Analysis of blood(Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.)
- Assessment of blood pressure(Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.)
- Assessment of peripheral oxygen saturation(Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.)
- Fatigue in epileptic and cancer patients(Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.)
- Assessment of heart rate(Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.)
- Quality of life in epileptic patients(Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.)
- Brain electrical activity in epileptic patients(Change from Baseline the results anxiety at 8 weeks.)
- Pain intensity(Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.)
- Autonomic Response in epileptic patients(Change from Baseline the results anxiety at 8 weeks.)
研究者
Elida Mara Carneiro da Silva
Doctor of Health Sciences
Universidade Federal do Triangulo Mineiro