Emotional StressNCT03162770
Mindfulness Meditation Practice During Hemodialysis
A study testing Mindfulness meditation practice in people with Emotional Stress and Hemodialysis Complication, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Emotional Stress, Hemodialysis Complication
- What is being tested?
- Mindfulness meditation practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2017to 30 Jun 2018
- 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
- Be a patient at Einstein Dialysis Center
- Have signed the informed consent
Who cannot join
- Have not signed the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiological and Psychological Impact of Mindfulness Meditation Practice on Chronic Hemodialysis Patients
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.
Read the detailed 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).
- Conditions
- Emotional Stress, Hemodialysis Complication
- Being tested
- Mindfulness meditation practice
- Keywords
- mindfulness meditation, hemodialysis, quality of life, stress
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness meditation practiceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | This group will receive the Mindfulness meditation practice and after that patients will not receive any other intervention. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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).
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start1 Jan 2017
- Primary completion1 Mar 2018 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional StressStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162770
- Sponsor's protocol ID
- 56794716.1.0000.0071
- Status last verified
- Jan 2017
- First submitted
- 3 May 2017
- Last updated
- 22 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Regular notification when treatment is discontinued, e.g., transplant treatment, death or transfer of dialysis unit
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological and Psychological Impact of Mindfulness Meditation Practice on Chronic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03162770
- Acronym / sponsor ID
- 56794716.1.0000.0071
- Conditions
- Emotional Stress, Hemodialysis Complication
- Keywords
- mindfulness meditation, hemodialysis, quality of life, stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Mar 2018 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 22 May 2017 (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 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.
Detailed 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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Mindfulness meditation practiceThis group will receive the Mindfulness meditation practice and after that patients will not receive any other intervention. |
| No Control Group | No intervention | –Initially this control group will wait and after 12 weeks this group will receive the intervention |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Be a patient at Einstein Dialysis Center
- Have signed the informed consent
Key exclusion criteria (1 listed)
- Have not signed the informed consent
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 meditation practiceThis 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. | Behavioural | Intervention Group |
Primary outcome
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).
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)
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
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
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).
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.
Assessment of comorbidities
Time frame: up to 12 months
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
- Individual participant dataSharing planned: Yes. Regular notification when treatment is discontinued, e.g., transplant treatment, death or transfer of dialysis unit
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 meditation practice in people with Emotional Stress and Hemodialysis Complication, run by Hospital Israelita Albert Einstein 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 May 2017. 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?
Results are not available in the source record.
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?
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). The study lists 7 primary outcomes in all. 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 May 2017.