Mindfulness Meditation Practice During Hemodialysis

NCT03162770 | Unknown DMC

• 1 other identifier: 56794716.1.0000.0071
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotional Stress; Hemodialysis Complication

Keywords

mindfulness meditation; hemodialysis; quality of life; stress

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Behavioral: Mindfulness meditation practice

No Control Group

NO INTERVENTION

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

Interventions

Mindfulness meditation practice 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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Have not signed the informed consent

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Erika Bevilaqua Rangel

São Paulo, São Paulo, 05652-900, Brazil

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 22, 2017
• Study Start: January 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: June 30, 2018
• Last Updated: May 22, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)