Effects of a Mindfulness-based Intervention in Stress, Pain and Quality of Life in People Undergoing Hemodialysis

December 7, 2021 updated by: Hospital de Clinicas de Porto Alegre

Effects of a Mindfulness-based Intervention in the Reduction of Stressors, Pain Profile and Quality of Life of People With Chronic Renal Disease in Hemodialysis

This project has as main objective to evaluate the effects of a Mindfulness-based intervention (MBI) in the reduction of stressors, pain and quality of life of people with chronic kidney disease undergoing hemodialysis (HD). The investigators hypothesize that this program offered during hemodialysis sessions may modify the pain profile, stressors levels and may improve the quality of life by the people in hemodialysis. This is an incipient field of research at the international level and almost nonexistent in Brazil. Evidence indicates the need for MBIs to be performed during HD sessions, adapted to the context, to facilitate patient compliance, contribute to the management of the discomfort generated during HD and promote health.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Chronic kidney disease (CKD) is considered a global public health problem, which affects approximately 10% of the world population. Due to partial or total loss of kidney function, the patient needs renal replacement therapy, with hemodialysis (HD) being the therapy most used, having a prevalence of up to 93.1% in Brazil. The restrictions imposed by CKD and the treatment of prolonged HD negatively affect health, increasing stress and decreasing the quality of life (QoL). The restrictions imposed by CKD and the treatment of prolonged HD negatively affect health, increasing stress and decreasing the QoL. Hemodialysis supports life and relieves a series of symptoms; however, it imposes many limitations. Social, financial and family stressors are numerous when dealing with the symptoms of the disease, restrictions and treatment prescriptions. Research shows positive results from Mindfulness-Based Interventions (MBIs) in reducing symptoms of different chronic diseases and mental and physical disorders such as: depression, anxiety, hypertension, cancer, chronic pain, cardiovascular diseases, insomnia, addictive behaviors, and kidney disease, and in improving medication adherence. This is an incipient field of research at the international level and almost nonexistent in Brazil. Evidence indicates the need for MBIs to be performed during HD sessions, adapted to the context, to facilitate patient compliance, contribute to the management of the discomfort generated during HD and promote health. This project has as main objectives to develop and evaluate the effects of a mindfulness-based intervention in the reduction of stressors, pain and quality of life of people undergoing hemodialysis. For this purpose, a randomized controlled pragmatic study with random allocation and blinding of the outcome evaluator will be performed, using quantitative and qualitative measures evaluated within 6 months after the intervention. The results of this research could form a consistent basis for a new and promising field of research that could contribute to improving the health of people undergoing hemodialysis and other populations that need long-term hospital care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-007
        • Hospital de Clínicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Higher than 18 years old;
  • Undergoing hemodialysis for at least three months;
  • Auditory acuity to listen to Mindfulness practices;
  • Be interested in the objectives of this study and be randomized in one of the two groups (MBI or TAU).

Exclusion Criteria:

  • Severe cognitive impairment or severe psychiatric disorder diagnosed by the medical staff of the nephrology unit;
  • Suicidal ideation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
This group will receive a Mindfulness-based intervention for 8 weeks, and after the intervention this participants will continuous their treatment as usual
Behavioral: Mindfulness-based Intervention
A mindfulness-based intervention will be developed for chronic hemodialysis patients to be performed during hemotherapy sessions. This is an integrative mind-body program, which is based on the MBRP (Bowen et al., 2014) and BMT (T. Russell, 2015) protocols. The program will be conducted in eight weeks, with a weekly individual session of up to 60 minutes facilitated by an instructor, at the bedside during the HD session. The program aims to develop awareness of bodily sensations, emotions and thoughts, with an attitude of openness, curiosity, kindness and non-judgment. During the sessions will be worked four main techniques of mindfulness meditation: mindfulness in breathing, body scanning, conscious movements and practice of compassion. Participants are invited and encouraged to practice Mindfulness using audios made available during the other HD sessions they undergo during the week, in addition to daily home practice.
No Intervention: Treatment as Usual
Patients in the control group received treatment as usual in the hemodialysis setting: Carry out hemodialysis sessions three times a week, on alternate days, for approximately 4 hours added to appointments and procedures performed by professionals from different areas (medicine, nursing, nutrition, physical education, social work, pharmacy, psychology).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Acceptance
Time Frame: Change from Baseline in AAQ-II at 6 months
The Acceptance & Action Questionnaire (AAQ-II) is a self-report questionnaire of seven items and aims to measure experiential avoidance. The answers are arranged on a seven-point Likert scale, in which 1 corresponds to "never true" and 7 to "always true". The final scores range from 10 to 70 points, with low scores corresponding to greater acceptance and ability to act in the presence of difficult thinking and emotions.
Change from Baseline in AAQ-II at 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Renal disease and quality of life
Time Frame: Change from Baseline in KDQOL-SF at 6 months
The Kidney Disease Quality of Life - Short Form (KDQOL-SF) is a self-reported measure that assesses the functioning and wellbeing of people with kidney disease and on dialysis. This scale is divided in 4 domains: Your Health, Kidney Disease, Effects of kidney disease on your daily life and Satisfaction with treatment. The scores on each dimension range from 0 (worst) to 100 range (better).
Change from Baseline in KDQOL-SF at 6 months
Depression, anxiety and stress
Time Frame: Change from Baseline in DASS-21 at 6 months
The Depression, Anxiety and Stress Scale DASS-21 is a self-report scale containing three subscales scored in a four-point Likert format, ranging from 0 ("Strongly Disagree") to 3 ("Strongly Agree") in increasing order of symptom severity and frequency. Each subscale of the DASS consists of seven items that assess the states of depression (range 0-21), anxiety (range 0-20) and stress (range 0-21), where higher scores are indicative of higher levels of psychological distress.
Change from Baseline in DASS-21 at 6 months
Interest in Mindfulness
Time Frame: Change from Baseline in Interest in Mindfulness at 6 months
Analogue scale of interest in mindfulness where participants must fill in a scale of 1 to 10, how much they are interested in mindfulness practices, where 1 corresponds to "I am not at all interested" and 10 corresponds to "I am very interested".
Change from Baseline in Interest in Mindfulness at 6 months
Level of Mindfulness
Time Frame: Change from Baseline in FFMQ at 6 months
The Five Facet Mindfulness Questionnaire (FFMQ) is a self-report scale that measures the level of Mindfulness through a multidimensional evaluation of its five facets: non-reactivity to inner experience, observe, act with awareness, describe and not judgment of inner experience. It includes 39-items that are rated on a 5-point Likert-type scale ranging from 1 (never or very rarely true) to 5 (very often or always true), with higher scores indicating higher levels of mindfulness skills.
Change from Baseline in FFMQ at 6 months
Pain Profile
Time Frame: Change from Baseline in PCP:S at 6 months
The Profile of Chronic Pain: Screen (PCP:S) is a self-report scale with fifteen items that allow the rapid identification of the pain experience on a multidimensional level of an individual. It is divided into three dimensions: frequency and intensity of pain (four items; score from 0 to 30), interference of pain in daily activities (six items; score from 0 to 36) and effect of pain on emotions (five items; score from 0 to 25). It guides patients to assess the frequency of any pain, average pain, severity, and the highest pain intensity over the past 6 months.
Change from Baseline in PCP:S at 6 months
Self-Compassion
Time Frame: Change from Baseline in SCS at 6 months
The Self-Compassion Scale (SCS) is a self-report questionnaire that includes three basic components: self kindness (extend gentleness and understanding to self rather than self-criticism), ordinary humanity (see your experience as a part of the human experience, rather than being isolated) and Mindfulness (not over-identification with thoughts and more painful feelings). 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.
Change from Baseline in SCS at 6 months
Biological markers
Time Frame: Change from Baseline in C-reactive protein and interleukin 6 at 6 months
Plasma concentrations of inflammatory markers (C-reactive protein and interleukin 6) will be measured.
Change from Baseline in C-reactive protein and interleukin 6 at 6 months
Inquiry of the Mindfulness Practice
Time Frame: During the 8 weeks of Intervention
In each mindfulness session, after the practices, an inquiry will be carried out focused on the participant's described experience, where one describes bodily sensations, emotions and thoughts perceived during the practice. This description is made from the investigation of the mindfulness instructor.
During the 8 weeks of Intervention
Interviews
Time Frame: During the 8 weeks of Intervention and after intervention
Interviews will be carried out with participants of the studied phenomenon or with key informants who know about the phenomenon or context researched. Conducted individually and semi-structured based on a script designed to ensure coverage of the investigated indicators.
During the 8 weeks of Intervention and after intervention
Feasibility of the Hemomindful Program
Time Frame: During the 8 weeks of Intervention and after intervention

Retention to the study protocol will be assessed using the primary data of all participants at the beginning of the study.

The adherence to the Hemomindful Program, implementation, security, and satisfaction of the treatment will be assessed through all the participants of the Intervention Group.
During the 8 weeks of Intervention and after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital de Clinicas de Porto Alegre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Angélica N Adamoli, MD, Nephrology Service Hospital de Clinicas de Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 8, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 20, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-0017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings