Effects of a Mindfulness-based Intervention in the Reduction of Stressors, Pain Profile and Quality of Life of People With Chronic Renal Disease in Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Pain Acceptance
研究概览
简要总结
This project has as main objective to evaluate the effects of a Mindfulness-based intervention (MBI) in the reduction of stressors, pain and quality of life of people with chronic kidney disease undergoing hemodialysis (HD). The investigators hypothesize that this program offered during hemodialysis sessions may modify the pain profile, stressors levels and may improve the quality of life by the people in hemodialysis. This is an incipient field of research at the international level and almost nonexistent in Brazil. Evidence indicates the need for MBIs to be performed during HD sessions, adapted to the context, to facilitate patient compliance, contribute to the management of the discomfort generated during HD and promote health.
详细描述
Chronic kidney disease (CKD) is considered a global public health problem, which affects approximately 10% of the world population. Due to partial or total loss of kidney function, the patient needs renal replacement therapy, with hemodialysis (HD) being the therapy most used, having a prevalence of up to 93.1% in Brazil. The restrictions imposed by CKD and the treatment of prolonged HD negatively affect health, increasing stress and decreasing the quality of life (QoL). The restrictions imposed by CKD and the treatment of prolonged HD negatively affect health, increasing stress and decreasing the QoL. Hemodialysis supports life and relieves a series of symptoms; however, it imposes many limitations. Social, financial and family stressors are numerous when dealing with the symptoms of the disease, restrictions and treatment prescriptions. Research shows positive results from Mindfulness-Based Interventions (MBIs) in reducing symptoms of different chronic diseases and mental and physical disorders such as: depression, anxiety, hypertension, cancer, chronic pain, cardiovascular diseases, insomnia, addictive behaviors, and kidney disease, and in improving medication adherence. This is an incipient field of research at the international level and almost nonexistent in Brazil. Evidence indicates the need for MBIs to be performed during HD sessions, adapted to the context, to facilitate patient compliance, contribute to the management of the discomfort generated during HD and promote health. This project has as main objectives to develop and evaluate the effects of a mindfulness-based intervention in the reduction of stressors, pain and quality of life of people undergoing hemodialysis. For this purpose, a randomized controlled pragmatic study with random allocation and blinding of the outcome evaluator will be performed, using quantitative and qualitative measures evaluated within 6 months after the intervention. The results of this research could form a consistent basis for a new and promising field of research that could contribute to improving the health of people undergoing hemodialysis and other populations that need long-term hospital care.
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Higher than 18 years old;
- •Undergoing hemodialysis for at least three months;
- •Auditory acuity to listen to Mindfulness practices;
- •Be interested in the objectives of this study and be randomized in one of the two groups (MBI or TAU).
排除标准
- •Severe cognitive impairment or severe psychiatric disorder diagnosed by the medical staff of the nephrology unit;
- •Suicidal ideation.
结局指标
主要结局
Pain Acceptance
时间窗: Change from Baseline in AAQ-II at 6 months
The Acceptance \& Action Questionnaire (AAQ-II) is a self-report questionnaire of seven items and aims to measure experiential avoidance. The answers are arranged on a seven-point Likert scale, in which 1 corresponds to "never true" and 7 to "always true". The final scores range from 10 to 70 points, with low scores corresponding to greater acceptance and ability to act in the presence of difficult thinking and emotions.
次要结局
- Depression, anxiety and stress(Change from Baseline in DASS-21 at 6 months)
- Pain Profile(Change from Baseline in PCP:S at 6 months)
- Interest in Mindfulness(Change from Baseline in Interest in Mindfulness at 6 months)
- Self-Compassion(Change from Baseline in SCS at 6 months)
- Biological markers(Change from Baseline in C-reactive protein and interleukin 6 at 6 months)
- Interviews(During the 8 weeks of Intervention and after intervention)
- Feasibility of the Hemomindful Program(During the 8 weeks of Intervention and after intervention)
- Level of Mindfulness(Change from Baseline in FFMQ at 6 months)
- Inquiry of the Mindfulness Practice(During the 8 weeks of Intervention)
- Renal disease and quality of life(Change from Baseline in KDQOL-SF at 6 months)