Effects of a Mindfulness-based Intervention in Stress, Pain and Quality of Life in People Undergoing Hemodialysis

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Renal Insufficiency, Chronic, Kidney Failure, Chronic, Kidney Diseases, Kidney Insufficiency, Chronic, Chronic Kidney Diseases, End-Stage Kidney Disease

Intervention / Treatment
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* Behavioral: Mindfulness-based Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: Severe cognitive impairment or severe psychiatric disorder diagnosed by the medical staff of the nephrology unit; Suicidal ideation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>This group will receive a Mindfulness-based intervention for 8 weeks, and after the intervention this participants will continuous their treatment as usual | Behavioral: Mindfulness-based Intervention<br>* 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.<br>|
| No Intervention: Treatment as Usual<br>Patients in the control group received treatment as usual in the hemodialysis setting: Carry out hemodialysis sessions three times a week, on alternate days, for approximately 4 hours added to appointments and procedures performed by professionals from different areas (medicine, nursing, nutrition, physical education, social work, pharmacy, psychology). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Acceptance | 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. | Change from Baseline in AAQ-II at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal disease and quality of life | The Kidney Disease Quality of Life - Short Form (KDQOL-SF) is a self-reported measure that assesses the functioning and wellbeing of people with kidney disease and on dialysis. This scale is divided in 4 domains: Your Health, Kidney Disease, Effects of kidney disease on your daily life and Satisfaction with treatment. The scores on each dimension range from 0 (worst) to 100 range (better). | Change from Baseline in KDQOL-SF at 6 months | 
| Depression, anxiety and stress | The Depression, Anxiety and Stress Scale DASS-21 is a self-report scale containing three subscales scored in a four-point Likert format, ranging from 0 (Strongly Disagree) to 3 (Strongly Agree) in increasing order of symptom severity and frequency. Each subscale of the DASS consists of seven items that assess the states of depression (range 0-21), anxiety (range 0-20) and stress (range 0-21), where higher scores are indicative of higher levels of psychological distress. | Change from Baseline in DASS-21 at 6 months | 
| Interest in Mindfulness | Analogue scale of interest in mindfulness where participants must fill in a scale of 1 to 10, how much they are interested in mindfulness practices, where 1 corresponds to I am not at all interested and 10 corresponds to I am very interested. | Change from Baseline in Interest in Mindfulness at 6 months | 
| Level of Mindfulness | The Five Facet Mindfulness Questionnaire (FFMQ) is a self-report scale that measures the level of Mindfulness through a multidimensional evaluation of its five facets: non-reactivity to inner experience, observe, act with awareness, describe and not judgment of inner experience. It includes 39-items that are rated on a 5-point Likert-type scale ranging from 1 (never or very rarely true) to 5 (very often or always true), with higher scores indicating higher levels of mindfulness skills. | Change from Baseline in FFMQ at 6 months | 
| Pain Profile | The Profile of Chronic Pain: Screen (PCP:S) is a self-report scale with fifteen items that allow the rapid identification of the pain experience on a multidimensional level of an individual. It is divided into three dimensions: frequency and intensity of pain (four items; score from 0 to 30), interference of pain in daily activities (six items; score from 0 to 36) and effect of pain on emotions (five items; score from 0 to 25). It guides patients to assess the frequency of any pain, average pain, severity, and the highest pain intensity over the past 6 months. | Change from Baseline in PCP:S at 6 months | 
| Self-Compassion | The Self-Compassion Scale (SCS) is a self-report questionnaire that includes three basic components: self kindness (extend gentleness and understanding to self rather than self-criticism), ordinary humanity (see your experience as a part of the human experience, rather than being isolated) and Mindfulness (not over-identification with thoughts and more painful feelings). The answers are given on a likert scale (1- almost never to 5 almost always), when the answers are not compassionate they must be calculated inversely. | Change from Baseline in SCS at 6 months | 
| Biological markers | Plasma concentrations of inflammatory markers (C-reactive protein and interleukin 6) will be measured. | Change from Baseline in C-reactive protein and interleukin 6 at 6 months | 
| Inquiry of the Mindfulness Practice | In each mindfulness session, after the practices, an inquiry will be carried out focused on the participant's described experience, where one describes bodily sensations, emotions and thoughts perceived during the practice. This description is made from the investigation of the mindfulness instructor. | During the 8 weeks of Intervention | 
| Interviews | Interviews will be carried out with participants of the studied phenomenon or with key informants who know about the phenomenon or context researched. Conducted individually and semi-structured based on a script designed to ensure coverage of the investigated indicators. | During the 8 weeks of Intervention and after intervention | 
| Feasibility of the Hemomindful Program | Retention to the study protocol will be assessed using the primary data of all participants at the beginning of the study. The adherence to the Hemomindful Program, implementation, security, and satisfaction of the treatment will be assessed through all the participants of the Intervention Group. | During the 8 weeks of Intervention and after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End-Stage Kidney Disease, Chronic Kidney Diseases, Renal Dialysis