Mindfulness Meditation Practice During Hemodialysis

NCT ID: NCT03162770

Last Updated: 2017-05-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2018-06-30

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).

Conditions

Emotional Stress; Hemodialysis Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention Group

This group will receive the Mindfulness meditation practice and after that patients will not receive any other intervention.

Group Type: EXPERIMENTAL

Mindfulness meditation practice

Intervention Type: BEHAVIORAL

This intervention is based on relaxation, well-being promotion, meditation practices and positive psychological principles. The program has been conducted during hemodialysis session. It will last for 12 weeks, with duration of 15 to 25 minutes, three times a week.

No Control Group

Initially this control group will wait and after 12 weeks this group will receive the intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness meditation practice

This intervention is based on relaxation, well-being promotion, meditation practices and positive psychological principles. The program has been conducted during hemodialysis session. It will last for 12 weeks, with duration of 15 to 25 minutes, three times a week.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Have not signed the informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Israelita Albert Einstein

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Erika Bevilaqua Rangel

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

56794716.1.0000.0071

Identifier Type: -

Identifier Source: org_study_id