Chronic Kidney Disease Requiring HemodialysisMEDIANCT07054112
Efficacy of Live Online Course Mindfulness Program on Perceived Fatigue in Hemodialysis Patients
A study testing Mindfulness-Based Stress Reduction (MBSR) meditation program in people with Chronic Kidney Disease Requiring Hemodialysis, run by University Hospital, Tours at 10 sites in France.
Trial summary
The goal of this clinical trial is to assess the efficacy of a 2-month live online mindfulness meditation program in reducing perceived fatigue (measured by the SONG-HD Fatigue Scale) in patients undergoing chronic hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Requiring Hemodialysis
- What is being tested?
- Mindfulness-Based Stress Reduction (MBSR) meditation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 10 sitesFrance
- Study dates
- 30 Sep 2025to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years old
- Written informed consent obtained from the participant
- Patients on chronic hemodialysis for more than 3 months
- Participant affiliated to social security system
- Internet access
- Patient motivation/commitment
- Patient having 3 days of dialysis per week
Who cannot join
- Major acute depression
- Patient on peritoneal dialysis
- Already participated in an MBSR program
- Patients covered by articles L1121-5 to L1121-8 of the French Public Health Code (corresponding to protected persons: pregnant women, women who have recently given birth or are breastfeeding, persons deprived of their rights by judicial or administrative decision, minors, and persons benefiting from legal protection: curatorship or guardianship).
- Planned hospitalization within 4 months
- Known cognitive disorder (Mini Mental State Evaluation <23 for more than 65 years)
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- Known schizophrenia
- Known psychotic personality disorder
- Suicide attempt or suicidal ideation
- Addiction to alcohol or drugs during addiction treatment
- Cancer undergoing chemotherapy
- Pathological grieving process
- Compulsive eating disorders
- No understanding of French
- Unaided deafness
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
France10 sites
CH Angers
Angers
Virginie BESSON, vibesson@chu-angers.fr
CH Bayonne
Bayonne
Pauline D'HALLUIN, pdhalluin@ch-cotebasque.fr
CHRU de Bordeaux
Bordeaux
Thomas BACHELET, thomas.bachelet@mailo.com
AIRBP 28
Chartres
Virginie CHAIGNE, vchaigne@airbp-dial.fr
AURAD Aquitaine
Gradignan
Mathilde PREZEUN-REYDIT, mathilde.reydit@maisondurein-aurad.fr
CHD Vendée
La Roche-sur-Yon
Anne Hélène QUERARD, anne-helene.querard@ght85.fr
ECHO Nantes
Nantes
Lila GHOUTI, lghouti@echo-sante.com
ATTIRO Orléans
Orléans
Alexandru GANEA, alexandru.ganea@chr-orleans.fr
CHRU De Tours
Tours, 37000
Nicolas GOIN, (+33) 2 47 47 37 39, nicolas.goin@chu-tours.fr
CALYDIAL
Vienne
Abdallah GUERRAOUI, Abdallah.guerraoui@calydial.org
About this study
The goal of this clinical trial is to assess the efficacy of a 2-month live online mindfulness meditation program in reducing perceived fatigue (measured by the SONG-HD Fatigue Scale) in patients undergoing chronic hemodialysis.
The sponsor expects that a live online mindfulness meditation course will have a significant public health impact by reducing perceived fatigue, which is strongly associated with cardiovascular events, mortality, and reduced quality of life.
Read more
Participants will be enrolled according to eligibility criteria and randomized into one of the following groups:
Experimental group: will receive an 8-week live online Mindfulness-Based Stress Reduction (MBSR) program.
Control group: will receive standard care during their hemodialysis sessions and will be offered the same live online MBSR program between months 8 and 10.
Patients will complete self-administered questionnaires at baseline, 2 months, 8 months, and 10 months to monitor changes in fatigue, anxiety, and quality of life.
Read the detailed description
Chronic kidney disease requiring a replacement therapy is a main public health issue. The overall incidence of treated end-stage renal disease is 169 per million inhabitants in France (Annual REIN report, Biomedicine Agency, 2021). Chronic kidney disease patients requiring a replacement therapy have a very increased mortality compared to the general population and their quality of life is particularly impacted.
The international initiative Standardized Outcomes in Nephrology hemodialysis (SONG-HD) has identified and prioritized the most important outcomes for patients requiring hemodialysis. The patients, their caregivers and health professionals have highlighted that perceived fatigue is one of the biggest issues once the hemodialysis began. Fatigue is a complex and subjective experience which include physical (muscular weakness, low stamina) and psychological symptoms (feeling of increased effort and decrease cognitive endurance). For patients with chronic hemodialysis, additionally to the burden of disease, they must receive in average three dialysis sessions per week which is a source of exhaustion. Fatigue is associated with an increase of cardiovascular events, an increase of mortality, a reduction of quality of life and consequently a less good compliance to dialysis. The outcome "fatigue" is then one of the critically important outcomes which must be assessed in all clinical trials and the investigators need to explore interventions to improve well-being of patients and to prevent patient's exhaustion.
Mindfulness meditation is defined as moment to moment self-regulation of attention. This practice helps cultivate non-judgmental acceptance of the present moment. Besides, a cognitive behavioral therapy including meditation significantly improve the well-being, the mood, the anxiety and stress perception of chronic hemodialysis patients. Several studies have showed that mindfulness meditation is associated with a decrease of systolic blood pressure, a decrease of depressive symptoms and an increase in self-compassion scores in hemodialysis patients.
Numerous studies have shown a significant improvement in fatigue thanks to a mindfulness meditation program in patients with lung cancer, breast cancer, in healthcare workers facing fatigue linked to empathic distress or even in volleyball athletes presenting moral fatigue linked to strong competition. However, to our knowledge, there is no study assessing the impact of a mindfulness meditation program on fatigue patients receiving chronic hemodialysis.
The investigators hypothesize that mindfulness meditation could regulate the psychological and physical perceived fatigue of hemodialysis patients. Meditation provides techniques allowing the participant to learn to step back from emotions, thoughts and experience in general. This is the decentring process. Furthermore, yoga, which is a part of the program, can help regulate the physical aspects of fatigue by leading to an increase in muscle mass and cardiac activity.
Benefit/ risk balance Non-invasive test. Very favorable benefit/risk balance, taking into account the demonstrated benefits in terms of stress and fatigue management of mindfulness meditation programs.
Absence of serious adverse effects reported under normal conditions while respecting the usual contraindications corresponding to the inclusion criteria.
A recent research showed that practicing mindfulness meditation is associated with transient distress and negative impacts at rates similar to other psychological treatments.
- Being tested
- Mindfulness-Based Stress Reduction (MBSR) meditation program, Control group
- Keywords
- chronic kidney desease, MBSR program, fatigue, Song scale
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress Reduction (MBSR) meditation programOther
The sessions of the meditation program (Mindfulness on Stress Reduction) will be delivered online, outside of the dialysis sessions. They will receive standard care during their hemodialysis sessions.
The program is composed of 8 sessions of 2h30 + 1 day of mindfulness, during 2 months.
Control groupOther
Patients in the control group will be in a wait list group. They will receive standard care during their hemodialysis sessions. they will receive the MBSR meditation program between M8 and M10.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients receive an MBSR (Mindfulness on Stress Reduction) meditation program delivered by a certified instructor. Receives: Other: Mindfulness-Based Stress Reduction (MBSR) meditation program |
| Control group | Other | Patients will be in a wait list group. They will receive their usual care during the study follow-up. Between M8 and M10 they will receive a MBSR meditation program Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the SONG-HD fatigue scale between baseline and 2 months follow-up.
SONG-HD scale means Standardised Outcomes in Nephrology-Haemodialysis; The score will vary from 0 to a maximum of 9
Measured: Between baseline and 2 months follow-up.
Secondary outcomes (8)
Evolution of the score on the SONG-Fatigue scale between baseline, M2, M8 and M10
SONG-HD scale means Standardised Outcomes in Nephrology-Haemodialysis; The score will vary from 0 to a maximum of 9
Measured: between baseline, Month-2, Month-8 and Month-10
Evolution of MFI score between baseline, M2, M8
MFI means Multidimensional Fatigue Inventory. The score will vary from 0 to a maximum of 100
Measured: between baseline, Month-2, Month-8
Evolution of quality of life (KDQOL) at baseline, M2, M8
KDQOL means Kidney Disease Quality of Life
Measured: at baseline, Month-2, Month-8
Evolution of anxiety (HAD) between baseline, M2, M8
HAD means Hospital Anxiety and Depression scale. The HAD scale is a screening instrument for anxiety and depressive disorders. It comprises 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven to depression (total D), giving two scores (maximum score for each = 21).
Measured: between baseline, Month-2, Month-8
Evolution of Mindfulness Score (FFMQ) between baseline, M2 and M8
FFMQ means Five Facet Mindfulness Questionnaire. It comprises 39 questions. Each item ranges from 1 to 5.
Measured: between baseline, Month-2 and Month-8
The occurrence of cardiovascular events at M8
Measured: at Month-8
Mortality at M8
Measured: At Month-8
The number of vascular access events at M8
Measured: At Month-8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start30 Sep 2025 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Requiring HemodialysisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marine NAUDIN, PhD, Principal investigator, CHRU de Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054112
- Sponsor's protocol ID
- DR240292
- Acronym
- MEDIA
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Live Online Course Mindfulness Program on Perceived Fatigue in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07054112
- Acronym / sponsor ID
- MEDIA / DR240292
- Keywords
- chronic kidney desease, MBSR program, fatigue, Song scale
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 8 Jul 2025 (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.
The goal of this clinical trial is to assess the efficacy of a 2-month live online mindfulness meditation program in reducing perceived fatigue (measured by the SONG-HD Fatigue Scale) in patients undergoing chronic hemodialysis.
The sponsor expects that a live online mindfulness meditation course will have a significant public health impact by reducing perceived fatigue, which is strongly associated with cardiovascular events, mortality, and reduced quality of life.
Participants will be enrolled according to eligibility criteria and randomized into one of the following groups:
Experimental group: will receive an 8-week live online Mindfulness-Based Stress Reduction (MBSR) program.
Control group: will receive standard care during their hemodialysis sessions and will be offered the same live online MBSR program between months 8 and 10.
Patients will complete self-administered questionnaires at baseline, 2 months, 8 months, and 10 months to monitor changes in fatigue, anxiety, and quality of life.
Detailed description
Chronic kidney disease requiring a replacement therapy is a main public health issue. The overall incidence of treated end-stage renal disease is 169 per million inhabitants in France (Annual REIN report, Biomedicine Agency, 2021). Chronic kidney disease patients requiring a replacement therapy have a very increased mortality compared to the general population and their quality of life is particularly impacted.
The international initiative Standardized Outcomes in Nephrology hemodialysis (SONG-HD) has identified and prioritized the most important outcomes for patients requiring hemodialysis. The patients, their caregivers and health professionals have highlighted that perceived fatigue is one of the biggest issues once the hemodialysis began. Fatigue is a complex and subjective experience which include physical (muscular weakness, low stamina) and psychological symptoms (feeling of increased effort and decrease cognitive endurance). For patients with chronic hemodialysis, additionally to the burden of disease, they must receive in average three dialysis sessions per week which is a source of exhaustion. Fatigue is associated with an increase of cardiovascular events, an increase of mortality, a reduction of quality of life and consequently a less good compliance to dialysis. The outcome "fatigue" is then one of the critically important outcomes which must be assessed in all clinical trials and the investigators need to explore interventions to improve well-being of patients and to prevent patient's exhaustion.
Mindfulness meditation is defined as moment to moment self-regulation of attention. This practice helps cultivate non-judgmental acceptance of the present moment. Besides, a cognitive behavioral therapy including meditation significantly improve the well-being, the mood, the anxiety and stress perception of chronic hemodialysis patients. Several studies have showed that mindfulness meditation is associated with a decrease of systolic blood pressure, a decrease of depressive symptoms and an increase in self-compassion scores in hemodialysis patients.
Numerous studies have shown a significant improvement in fatigue thanks to a mindfulness meditation program in patients with lung cancer, breast cancer, in healthcare workers facing fatigue linked to empathic distress or even in volleyball athletes presenting moral fatigue linked to strong competition. However, to our knowledge, there is no study assessing the impact of a mindfulness meditation program on fatigue patients receiving chronic hemodialysis.
The investigators hypothesize that mindfulness meditation could regulate the psychological and physical perceived fatigue of hemodialysis patients. Meditation provides techniques allowing the participant to learn to step back from emotions, thoughts and experience in general. This is the decentring process. Furthermore, yoga, which is a part of the program, can help regulate the physical aspects of fatigue by leading to an increase in muscle mass and cardiac activity.
Benefit/ risk balance Non-invasive test. Very favorable benefit/risk balance, taking into account the demonstrated benefits in terms of stress and fatigue management of mindfulness meditation programs.
Absence of serious adverse effects reported under normal conditions while respecting the usual contraindications corresponding to the inclusion criteria.
A recent research showed that practicing mindfulness meditation is associated with transient distress and negative impacts at rates similar to other psychological treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Mindfulness-Based Stress Reduction (MBSR) meditation programPatients receive an MBSR (Mindfulness on Stress Reduction) meditation program delivered by a certified instructor. |
| Control group | Other | Other: Control groupPatients will be in a wait list group. They will receive their usual care during the study follow-up. Between M8 and M10 they will receive a MBSR meditation program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >= 18 years old
- Written informed consent obtained from the participant
- Patients on chronic hemodialysis for more than 3 months
- Participant affiliated to social security system
- Internet access
Key exclusion criteria (15 listed)
- Major acute depression
- Patient on peritoneal dialysis
- Already participated in an MBSR program
- Patients covered by articles L1121-5 to L1121-8 of the French Public Health Code (corresponding to protected persons: pregnant women, women who have recently given birth or are breastfeeding, persons deprived of their rights by judicial or administrative decision, minors, and persons benefiting from legal protection: curatorship or guardianship).
- Planned hospitalization within 4 months
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 Stress Reduction (MBSR) meditation programThe sessions of the meditation program (Mindfulness on Stress Reduction) will be delivered online, outside of the dialysis sessions. They will receive standard care during their hemodialysis sessions. The program is composed of 8 sessions of 2h30 + 1 day of mindfulness, during 2 months. | Other | Experimental group |
| Control groupPatients in the control group will be in a wait list group. They will receive standard care during their hemodialysis sessions. they will receive the MBSR meditation program between M8 and M10. | Other | Control group |
Primary outcome
Change in the SONG-HD fatigue scale between baseline and 2 months follow-up.
Time frame: Between baseline and 2 months follow-up.
SONG-HD scale means Standardised Outcomes in Nephrology-Haemodialysis; The score will vary from 0 to a maximum of 9
8 secondary outcomes
Evolution of the score on the SONG-Fatigue scale between baseline, M2, M8 and M10
Time frame: between baseline, Month-2, Month-8 and Month-10
Evolution of MFI score between baseline, M2, M8
Time frame: between baseline, Month-2, Month-8
Evolution of quality of life (KDQOL) at baseline, M2, M8
Time frame: at baseline, Month-2, Month-8
Evolution of anxiety (HAD) between baseline, M2, M8
Time frame: between baseline, Month-2, Month-8
Evolution of Mindfulness Score (FFMQ) between baseline, M2 and M8
Time frame: between baseline, Month-2 and Month-8
The occurrence of cardiovascular events at M8
Time frame: at Month-8
Mortality at M8
Time frame: At Month-8
The number of vascular access events at M8
Time frame: At Month-8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Marine NAUDIN, PhD principal investigator
CHRU de Tours
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction (MBSR) meditation program in people with Chronic Kidney Disease Requiring Hemodialysis, run by University Hospital, Tours at 10 sites in France.
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 7 inclusion and 15 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: opening soon, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marine NAUDIN, PhD (+33 2.47.47.91.23, m.naudin@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the SONG-HD fatigue scale between baseline and 2 months follow-up. (time frame: Between baseline and 2 months follow-up.). 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 8 Jul 2025.