Renal Insufficiency, ChronicNCT04610593
Effects of a Mindfulness-based Intervention in Stress, Pain and Quality of Life in People Undergoing Hemodialysis
A study testing Mindfulness-based Intervention in people with Renal Insufficiency, Chronic and Kidney Failure, Chronic, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Kidney Diseases
- What is being tested?
- Mindfulness-based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 6 May 2019to 20 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Severe cognitive impairment or severe psychiatric disorder diagnosed by the medical staff of the nephrology unit;
- Suicidal ideation.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-007
About this study
Official title: 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.
Read the 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.
- Conditions
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Kidney Diseases, Kidney Insufficiency, Chronic, Chronic Kidney Diseases, End-Stage Kidney Disease
- Being tested
- Mindfulness-based Intervention
- Keywords
- End-Stage Kidney Disease, Chronic Kidney Diseases, Renal Dialysis
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | This group will receive a Mindfulness-based intervention for 8 weeks, and after the intervention this participants will continuous their treatment as usual Receives: Behavioral: Mindfulness-based Intervention |
| Treatment as Usual | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Pain Acceptance
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.
Measured: Change from Baseline in AAQ-II at 6 months
Secondary outcomes (10)
Renal disease and quality of life
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).
Measured: Change from Baseline in KDQOL-SF at 6 months
Depression, anxiety and stress
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.
Measured: Change from Baseline in DASS-21 at 6 months
Interest in Mindfulness
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".
Measured: Change from Baseline in Interest in Mindfulness at 6 months
Level of Mindfulness
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.
Measured: Change from Baseline in FFMQ at 6 months
Pain Profile
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.
Measured: Change from Baseline in PCP:S at 6 months
Self-Compassion
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.
Measured: Change from Baseline in SCS at 6 months
Biological markers
Plasma concentrations of inflammatory markers (C-reactive protein and interleukin 6) will be measured.
Measured: Change from Baseline in C-reactive protein and interleukin 6 at 6 months
Inquiry of the Mindfulness Practice
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.
Measured: During the 8 weeks of Intervention
Interviews
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.
Measured: During the 8 weeks of Intervention and after intervention
Feasibility of the Hemomindful Program
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.
Measured: During the 8 weeks of Intervention and after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start6 May 2019
- Primary completion8 Jul 2019
- Study completion20 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angélica N Adamoli, MD, Principal investigator, Nephrology Service Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610593
- Sponsor's protocol ID
- 2019-0017
- Status last verified
- Dec 2021
- First submitted
- 9 Oct 2020
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04610593
- Acronym / sponsor ID
- 2019-0017
- Conditions
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Kidney Diseases, Kidney Insufficiency, Chronic, Chronic Kidney Diseases, End-Stage Kidney Disease
- Keywords
- End-Stage Kidney Disease, Chronic Kidney Diseases, Renal Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 6 May 2019 (actual)
- Primary completion
- 8 Jul 2019 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Mindfulness-based InterventionThis group will receive a Mindfulness-based intervention for 8 weeks, and after the intervention this participants will continuous their treatment as usual |
| Treatment as Usual | No intervention | –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). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- Severe cognitive impairment or severe psychiatric disorder diagnosed by the medical staff of the nephrology unit;
- Suicidal ideation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based InterventionA 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. | Behavioural | Intervention Group |
Primary outcome
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.
10 secondary outcomes
Renal disease and quality of life
Time frame: Change from Baseline in KDQOL-SF at 6 months
Depression, anxiety and stress
Time frame: Change from Baseline in DASS-21 at 6 months
Interest in Mindfulness
Time frame: Change from Baseline in Interest in Mindfulness at 6 months
Level of Mindfulness
Time frame: Change from Baseline in FFMQ at 6 months
Pain Profile
Time frame: Change from Baseline in PCP:S at 6 months
Self-Compassion
Time frame: 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
Inquiry of the Mindfulness Practice
Time frame: During the 8 weeks of Intervention
Interviews
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angélica N Adamoli, MD principal investigator
Nephrology Service Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Intervention in people with Renal Insufficiency, Chronic and Kidney Failure, Chronic, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Acceptance (time frame: Change from Baseline in AAQ-II at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.