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The goal of this clinical trial is to assess the efficacy of a 2-month live online mindfulness meditation program in reducing perceived fatigue (measured by the SONG-HD Fatigue Scale) in patients undergoing chronic hemodialysis.
The sponsor expects that a live online mindfulness meditation course will have a significant public health impact by reducing perceived fatigue, which is strongly associated with cardiovascular events, mortality, and reduced quality of life.
Participants will be enrolled according to eligibility criteria and randomized into one of the following groups:
Experimental group: will receive an 8-week live online Mindfulness-Based Stress Reduction (MBSR) program.
Control group: will receive standard care during their hemodialysis sessions and will be offered the same live online MBSR program between months 8 and 10.
Patients will complete self-administered questionnaires at baseline, 2 months, 8 months, and 10 months to monitor changes in fatigue, anxiety, and quality of life.
Full description
Chronic kidney disease requiring a replacement therapy is a main public health issue. The overall incidence of treated end-stage renal disease is 169 per million inhabitants in France (Annual REIN report, Biomedicine Agency, 2021). Chronic kidney disease patients requiring a replacement therapy have a very increased mortality compared to the general population and their quality of life is particularly impacted.
The international initiative Standardized Outcomes in Nephrology hemodialysis (SONG-HD) has identified and prioritized the most important outcomes for patients requiring hemodialysis. The patients, their caregivers and health professionals have highlighted that perceived fatigue is one of the biggest issues once the hemodialysis began. Fatigue is a complex and subjective experience which include physical (muscular weakness, low stamina) and psychological symptoms (feeling of increased effort and decrease cognitive endurance). For patients with chronic hemodialysis, additionally to the burden of disease, they must receive in average three dialysis sessions per week which is a source of exhaustion. Fatigue is associated with an increase of cardiovascular events, an increase of mortality, a reduction of quality of life and consequently a less good compliance to dialysis. The outcome "fatigue" is then one of the critically important outcomes which must be assessed in all clinical trials and the investigators need to explore interventions to improve well-being of patients and to prevent patient's exhaustion.
Mindfulness meditation is defined as moment to moment self-regulation of attention. This practice helps cultivate non-judgmental acceptance of the present moment. Besides, a cognitive behavioral therapy including meditation significantly improve the well-being, the mood, the anxiety and stress perception of chronic hemodialysis patients. Several studies have showed that mindfulness meditation is associated with a decrease of systolic blood pressure, a decrease of depressive symptoms and an increase in self-compassion scores in hemodialysis patients.
Numerous studies have shown a significant improvement in fatigue thanks to a mindfulness meditation program in patients with lung cancer, breast cancer, in healthcare workers facing fatigue linked to empathic distress or even in volleyball athletes presenting moral fatigue linked to strong competition. However, to our knowledge, there is no study assessing the impact of a mindfulness meditation program on fatigue patients receiving chronic hemodialysis.
The investigators hypothesize that mindfulness meditation could regulate the psychological and physical perceived fatigue of hemodialysis patients. Meditation provides techniques allowing the participant to learn to step back from emotions, thoughts and experience in general. This is the decentring process. Furthermore, yoga, which is a part of the program, can help regulate the physical aspects of fatigue by leading to an increase in muscle mass and cardiac activity.
Benefit/ risk balance Non-invasive test. Very favorable benefit/risk balance, taking into account the demonstrated benefits in terms of stress and fatigue management of mindfulness meditation programs.
Absence of serious adverse effects reported under normal conditions while respecting the usual contraindications corresponding to the inclusion criteria.
A recent research showed that practicing mindfulness meditation is associated with transient distress and negative impacts at rates similar to other psychological treatments.
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80 participants in 2 patient groups
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Bénédicte Sautenet, PU-PH; Marine NAUDIN, PhD
Data sourced from clinicaltrials.gov
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