Clinical trial NCT03162770: Mindfulness Meditation Practice During Hemodialysis
Official title: Physiological and Psychological Impact of Mindfulness Meditation Practice on Chronic Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emotional Stress
Hemodialysis Complication
Keywords: mindfulness meditation
hemodialysis
quality of life
stress
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Behavioral: Mindfulness meditation practice This intervention is based on relaxation, well-being promotion, meditation practices and positive psychology principles. The program is being evaluated in hemodialysis session. It will last for 12 weeks, with trainings of 15 to 25 minutes, three times a week.

No Intervention: Control App This group will observe their psychological and physical condition (levels of stress and well-being) during their daily activities and social interactions.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This protocol of meditation is based on mindfulness program proposes to train meditation during the hemodialysis session. The investigators hypothesize that this program offered during hemodialysis session may promote well-being, reduce symptoms of stress and depression reported by the patients, which ultimately may improve biochemical parameters resulting from better adherence to treatment. Objectives: To evaluate the effects of mindfulness meditation practice in patients on chronic hemodialysis, in order to verify if this training can improve symptoms of depression, stress, quality of life and sleep disturbances. Methods: fifty patients will be separated in two groups, twenty five each group, half of them in the control group (CG) and the other half to the intervention group (IG). The patients will be evaluated pre- and pos-protocol.

Detailed description: Introduction: Chronic kidney disease (CKD) affects thousands of people in the world, regardless of gender, race and age. CKD requires dialysis or renal transplant. In the case of dialysis, cardiovascular and infectious events adversely impact the survival and quality of life despite technological advances. Recently, brain-renal interaction has emerged as a key aspect for understanding the neurological disorders-related to CKD, such as cerebrovascular diseases, cognitive impairment, and autonomic, sensory and motor neuropathies. In addition, patients on chronic hemodialysis develop sleep disorders, like insomnia and central apnea, restless leg syndrome, depression, anxiety and stress. Mindfulness meditation practice has been reported to positively affect cardiovascular parameters, since that practice contributes to the decrease in blood pressure levels and premature heart beats occurrence through sympathetic nerve modulation, which collectively may lead to improve the quality of life. Objectives: To evaluate the effects of mindfulness meditation practice in patients on chronic hemodialysis, in order to verify if this training can improve symptoms of depression, stress, quality of life and sleep quality. Methods: fifty patients will be separated in two groups, twenty five each group, half of them in the control group (CG) and the other half in the intervention group (IG). The IG will be enrolled in the meditation protocol, for 12 weeks, 3 days a week during the hemodialysis session, while the CG will wait. Then after the evaluations, the CG will receive the intervention of meditation, while the IG will not receive any intervention. The groups will be evaluate before, 3-and 6-month follow-up periods. We will apply the following instruments: ICED (Index of coexistent diseases), KDQOL (Kidney Disease Quality of Life), BDI (Beck Depression Inventory), PSQI (Pittsburgh Sleep Quality Index), PSS (Perceived Stress Scale), MAAS (Mindful Attention Awareness Scale) and SCS (Self-Compassion Scale).

Eligibility criteria: Inclusion Criteria:

* Be a patient at Einstein Dialysis Center
* Have signed the informed consent

Exclusion Criteria:

* Have not signed the informed consent

Primary outcomes:
measure: Improvement of symptoms of depression, stress, quality of life, sleep disorders, biochemical parameters resulting from better adherence to treatment
timeFrame: up to 12 months
measure: Improvement of symptoms of quality of life
timeFrame: up to 12 months
measure: Improvement of symptoms of depression
timeFrame: up to 12 months
measure: Improvement of symptoms of sleep disorders
timeFrame: up to 12 months
measure: Improvement of symptoms of stress
timeFrame: up to 12 months
measure: Improve symptoms of depression and stress
timeFrame: up to 12 months
measure: Assessment of comorbidities
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Erika Bevilaqua Rangel
state: SP
Study officials:
References: