Effects of a Mindfulness-based Intervention in Stress, Pain and Quality of Life in People Undergoing Hemodialysis
Condition: Renal Insufficiency, Chronic; Kidney Failure, Chronic; Kidney Diseases; Kidney Insufficiency, Chronic; Chronic Kidney Diseases; End-Stage Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Mindfulness-based Intervention
Intervention type(s): Behavioral
Intervention description(s): A mindfulness-based intervention will be developed for chronic hemodialysis patients to be performed during hemotherapy sessions. This is an integrative mind-body program, which is based on the MBRP (Bowen et al., 2014) and BMT (T. Russell, 2015) protocols. The program will be conducted in eight weeks, with a weekly individual session of up to 60 minutes facilitated by an instructor, at the bedside during the HD session. The program aims to develop awareness of bodily sensations, emotions and thoughts, with an attitude of openness, curiosity, kindness and non-judgment. During the sessions will be worked four main techniques of mindfulness meditation: mindfulness in breathing, body scanning, conscious movements and practice of compassion. Participants are invited and encouraged to practice Mindfulness using audios made available during the other HD sessions they undergo during the week, in addition to daily home practice.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: End-Stage Kidney Disease; Chronic Kidney Diseases; Renal Dialysis