Clinical trial NCT04610593: Effects of a Mindfulness-based Intervention in Stress, Pain and Quality of Life in People Undergoing Hemodialysis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Insufficiency, Chronic
Kidney Failure, Chronic
Kidney Diseases
Kidney Insufficiency, Chronic
Chronic Kidney Diseases
End-Stage Kidney Disease
Keywords: End-Stage Kidney Disease
Chronic Kidney Diseases
Renal Dialysis
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Acceptance
timeFrame: Change from Baseline in AAQ-II at 6 months
Secondary outcomes:
measure: Renal disease and quality of life
timeFrame: Change from Baseline in KDQOL-SF at 6 months
measure: Depression, anxiety and stress
timeFrame: Change from Baseline in DASS-21 at 6 months
measure: Interest in Mindfulness
timeFrame: Change from Baseline in Interest in Mindfulness at 6 months
measure: Level of Mindfulness
timeFrame: Change from Baseline in FFMQ at 6 months
measure: Pain Profile
timeFrame: Change from Baseline in PCP:S at 6 months
measure: Self-Compassion
timeFrame: Change from Baseline in SCS at 6 months
measure: Biological markers
timeFrame: Change from Baseline in C-reactive protein and interleukin 6 at 6 months
measure: Inquiry of the Mindfulness Practice
timeFrame: During the 8 weeks of Intervention
measure: Interviews
timeFrame: During the 8 weeks of Intervention and after intervention
measure: Feasibility of the Hemomindful Program
timeFrame: During the 8 weeks of Intervention and after intervention
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Nephrology Service Hospital de Clinicas de Porto Alegre
name: Angélica N Adamoli, MD
role: PRINCIPAL_INVESTIGATOR
References: