Effects of Laying on of Hands on Women With Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change from Baseline Pain Intensity at 10 weeks
研究概览
简要总结
Fibromyalgia is conceptualized as non-inflammatory syndrome with manifestation in the musculoskeletal system associated with chronic generalized pain, fatigue, mood and sleep changes. Laying on of hands therapies are intended to prevent injuries, promote health recovery and harmony between the physical, mental and spiritual dimensions. The aim of this study is to evaluate the effects of laying on of hands with and without a spiritual connection on the mental and physical health, well-being and quality of life of women with fibromyalgia. 72 patients will be divided into 3 groups: control - without imposition of hands, imposition without spiritual presence with the intention of healing and imposition with spiritual presence through the spiritist passe.
详细描述
This is a triple-blind, randomized, controlled clinical trial of 10 weeks, with a minimum sample of 72 participants, to be carried out at the Center for Integrative and Complementary Practices of the Hospital de Clínicas da UFTM. Participants will be informed about the research objectives, their voluntary participation and anonymity. Then, they will be randomly placed in one of the groups: control, imposition by volunteers with healing intent (GIM) and spiritist passe. All participants will lie on a stretcher for about 5 minutes, then vital signs (blood pressure and heart rate and pain assessment by VAS) will be measured before, immediately after the intervention on days D1, D8 and D10. During the laying on of hands, they will receive the following verbal command: "Mentalize relief of pain and improvement of symptoms". After the end of the intervention, they will receive systemic acupuncture: the acupuncture application method will be standardized in all participants, insertion of a systemic needle 0.20 x 0.40 perpendicularly in the following points: pericardium 6, heart 7, spleen, pancreas 6, large intestine 4, liver 2, stomach 36 bilaterally and will remain for about 20 minutes. Participants will receive interventions lying on stretchers in a room prepared for this purpose. The eyes will be blindfolded with a visor made for the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
In this study, the blinding will be triple blinded because the Investigators, care provider, patients and Outcomes Assessor are unaware of which group the participants were allocated to. To ensure the blinding of the participants, their eyes will be blindfolded with a visor made for the study on a white compress.
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with fibromyalgia
- •up to 18 years
- •diagnosis of fibromyalgia according to ACR 2010 criteria
排除标准
- •pregnant women
- •treatment for cancer
- •inability to understand the questionnaires
- •refusing to sign the informed consent
结局指标
主要结局
Change from Baseline Pain Intensity at 10 weeks
时间窗: The results were obtained at baseline, eight and 10 weeks
Pain intensity will be evaluated by the Visual Analog Scale, whether higher scores mean a better outcome
Change from Baseline Fatigue at 10 weeks
时间窗: The results were obtained at baseline, eight and 10 weeks
Fatigue will be evaluated by fatigue pictogram, an illustrated instrument composed of two questions graded in 5 captioned illustrations that assess the intensity of fatigue, whether higher scores mean a better outcome
次要结局
- Change from Baseline Anxiety at 10 weeks(The results were obtained at baseline, eight and 10 weeks)
- Change from Baseline Qualities of Sleep at 10 weeks(The results were obtained at baseline, eight and 10 weeks)
- Change from Baseline Stress at 10 weeks(The results were obtained at baseline, eight and 10 weeks)
- Change from Baseline Depressive Symptons at 10 weeks(The results were obtained at baseline, eight and 10 weeks)
- Change from Baseline Impact of Fibromyalgia at 10 weeks(The results were obtained at baseline, eight and 10 weeks)
- Change from Baseline Qualities of Life at 10 weeks(The results were obtained at baseline, eight and 10 weeks)
- Change from Baseline Safety at 10 weeks(The results were obtained at baseline, eight and 10 weeks)
研究者
Elida Mara Carneiro da Silva
PhD
Universidade Federal do Triangulo Mineiro