Efficacy of Live Online Course Mindfulness Program on Perceived Fatigue in Hemodialysis Patients (NCT07054112) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy of Live Online Course Mindfulness Program on Perceived Fatigue in Hemodialysis Patients
France80 participantsStarted 2025-09-30
Plain-language 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.
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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)
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the SONG-HD fatigue scale between baseline and 2 months follow-up.
Timeframe: Between baseline and 2 months follow-up.