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

Hospital de Clinicas de Porto Alegre

Status: Completed

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

Treatments: Behavioral: Mindfulness-based Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04610593

2019-0017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Intervention Group

Experimental group

Description:

This group will receive a Mindfulness-based intervention for 8 weeks, and after the intervention this participants will continuous their treatment as usual

Treatment:

Behavioral: Mindfulness-based Intervention

Treatment as Usual

No Intervention group

Description:

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).