跳至主要内容
临床试验/CTRI/2024/08/073040
CTRI/2024/08/073040招募中不适用

The Effect of Meditation as an Adjuvant Therapy in Chronic Kidney Disease CKD A Pilot Study

Dr Ashween Bilagi1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年9月2日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Heart Rate Variability

研究概览

简要总结

Chronic kidney disease (CKD) is a progressive decline in renal function that affects a significant portion of the adult population. It is characterized by structural and functional abnormalities within the kidneys, often remaining asymptomatic during the initial stages but predisposing individuals to various complications, including cardiovascular ailments, end-stage renal failure, anemia, metabolic bone disorders, and neurological manifestations. CKD is typically defined by renal impairment or a glomerular filtration rate (GFR) below 60 mL/min/1.73 m^2, with albuminuria as an additional diagnostic criterion. CKD is associated with coronary artery disease, making managing it complex due to its multifaceted nature and concurrent comorbidities. CKD precipitates premature aging through mechanisms involving increased allostatic load, dysregulated stress response, facilitation of aging processes, and inhibition of anti-aging pathways. CKD patients experience a range of symptoms, including disturbances in sleep patterns, somnolence, fatigue, pruritus, anorexia, muscle cramping, and skeletal pain. Frailty is an independent correlate of heightened symptomatology and compromised health-related quality of life in CKD patients. Depression and anxiety are notably elevated among CKD patients, primarily due to the adverse health outcomes and diminished quality of life associated with the condition. Mind-body therapies, such as meditation, have been investigated for their potential role in CKD patients. Evidence suggests that mindfulness meditation can effectively mitigate chronic pain and mood disturbances, enhancing their overall quality of life. However, further research is needed to explore the potential benefits of meditation and its incorporation into standard treatment regimens for CKD patients undergoing dialysis.

Research on meditation’s impact on chronic kidney disease (CKD) patients has mainly focused on short-term outcomes, highlighting the need for longitudinal studies to evaluate its sustained effects on clinical parameters like dialysis efficacy, renal function, and overall health. The dose-response relationship between meditation practice and therapeutic benefits for CKD patients is unclear, necessitating further investigation to identify the optimal frequency, duration, and type of meditation practice. Evidence suggests meditation can improve emotional resilience and reduce stress in CKD patients, but the exact mechanisms are poorly understood. There is also a need to understand how meditation can be integrated into multidisciplinary healthcare settings, considering feasibility, scalability, and healthcare provider training. This study aims to examine the impact of meditation as an adjunctive therapeutic modality for improving CKD patients’ overall well-being, with potential for integration within the standard care regimen.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed with CKD and undergoing dialysis
  • Those who have given informed consent for completing the study
  • Those who are mentally and physically fit up to a minimum level to understand and perform the practices will be included.

排除标准

  • Participants with a history of substance abuse, psychotic illnesses, and those on therapy for psychotic illness.
  • Other chronic conditions, such as recent stroke and post-coronary artery bypass grafting.
  • Recent abdominal surgeries.
  • Solid organ or bone marrow transplant.
  • Palpitations or dyspnoea at rest or asymptomatic only when resting.
  • Pregnant women.
  • Those who are currently on immunosuppressive drug therapy.
  • Those with an expected life expectancy of less than 1 year.
  • Those with vocal cords or speech problems.
  • Those with exposure to yoga and meditation in the past 3 months.

结局指标

主要结局

Heart Rate Variability

时间窗: Data collection will be done first at baseline on the 0th day. Intervention will be given from day 1 to day 30. Post-data collection will be done on the 31st day.

Health-Related Quality of Life

时间窗: Data collection will be done first at baseline on the 0th day. Intervention will be given from day 1 to day 30. Post-data collection will be done on the 31st day.

次要结局

  • Perceived stress levels(Level of mindfulness)

研究者

发起方
Dr Ashween Bilagi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Ashween Bilagi

Sri Devaraj Urs Academy of Higher Education and Research

研究点 (1)

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