- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03162770
Mindfulness Meditation Practice During Hemodialysis
Physiological and Psychological Impact of Mindfulness Meditation Practice on Chronic Hemodialysis Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
SP
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Sao Paulo, SP, Brazil, 05652-900
- Erika Bevilaqua Rangel
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Be a patient at Einstein Dialysis Center
- Have signed the informed consent
Exclusion Criteria:
- Have not signed the informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
This group will receive the Mindfulness meditation practice and after that patients will not receive any other intervention.
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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.
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No Intervention: No Control Group
Initially this control group will wait and after 12 weeks this group will receive the intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of symptoms of depression, stress, quality of life, sleep disorders, biochemical parameters resulting from better adherence to treatment
Time Frame: up to 12 months
|
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
Time Frame: up to 12 months
|
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
Time Frame: up to 12 months
|
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
Time Frame: up to 12 months
|
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
Time Frame: up to 12 months
|
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
Time Frame: up to 12 months
|
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
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Assessment of comorbidities
Time Frame: up to 12 months
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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
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 56794716.1.0000.0071
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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