Mindfulness Meditation Practice During Hemodialysis

Hemodialysis Complication Clinical Trial

Official title:

Physiological and Psychological Impact of Mindfulness Meditation Practice on Chronic Hemodialysis Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03162770
• Other study ID #: 56794716.1.0000.0071
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 3, 2017
• Last updated: May 19, 2017
• Start date: January 1, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: January 2017
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: June 30, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Be a patient at Einstein Dialysis Center

• Have signed the informed consent

Exclusion Criteria:

• Have not signed the informed consent

Related Conditions & MeSH terms

• Emotional Stress
• Hemodialysis Complication
• Stress, Psychological

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Brazil	Erika Bevilaqua Rangel	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of symptoms of depression, stress, quality of life, sleep disorders, biochemical parameters resulting from better adherence to treatment	MAAS (Mindful Attention Awareness Scale): Self-report instrument that aims to measure individual differences in the frequency of states of consciousness and mind through time. The greater the more traces of attention (score 15-90).	up to 12 months
Primary	Improvement of symptoms of quality of life	KDQOL (Kidney Disease Quality of Life): Evaluates the perception of quality of life related to renal disease. The closer to 100 the better the perception of quality of life (Score 0-100 on each item- 24 items)	up to 12 months
Primary	Improvement of symptoms of depression	BDI (Beck Depression Inventory): From 10 to 18 = mild to moderate depression; From 19 to 29 = moderate to severe depression; From 30 to 63 = severe depression	up to 12 months
Primary	Improvement of symptoms of sleep disorders	PSQI (Pittsburgh Sleep Quality Index): Provides a measure of standardized sleep quality, the higher the score, the worse the quality of sleep, PSQI> 5 indicates that the individual is experiencing major difficulties in at least 2 components, or moderate difficulties in more than 3 components	up to 12 months
Primary	Improvement of symptoms of stress	PSS (Perceived Stress Scale): Evaluates perceived stress, the greater the more perceived stress (score 0-40).	up to 12 months
Primary	Improve symptoms of depression and stress	SCS (Self-Compassion Scale): 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.; The scale is subdivided into 6 sub-scales of each of the three mechanisms in their positive and negative characteristics (mindfulness vs. over-identification, self-kindness versus self-judgment, and common humanity vs. isolation). "Global self-pity scores were calculated by inversely encoding the items of self-judgment, isolation, and over-identification, adding up to the six sub-scales.	up to 12 months
Primary	Assessment of comorbidities	ICED (Index of coexistent diseases): The utilization of ICED enables stratifying the dialysis patients according to severity of their comorbidities and it is useful to identify the patients with a greater risk of death and hospitalization, as well as to aid in the forecast of and optimization of resources necessary for their treatment. The ICED aggregates the presence and severity of 19 medical conditions and 11 physical impairments within two scales: the Index of Disease Severity (IDS) and the Index of Physical Impairment (IPI). The final ICED score is determined by an algorithm combining the peak scores for the IDS and IPI. The range of the ICED is from 0 to 3, reflecting increasing severity ( 0 - normal, 1 - mild, 2- moderate, 3- severe).	up to 12 months