NCT07054112Not yet recruiting
Efficacy of Live Online Course Mindfulness Program on Perceived Fatigue in Hemodialysis Patients
Source: ClinicalTrials.gov · Last updated 8 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 13 Jun 2025
- Start date
- 30 Sept 2025
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- University Hospital, Tours
- Diseases
- Chronic kidney disease
- NCT number
- NCT07054112
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 30 Sept 2025 to the primary completion date, 30 Nov 2026
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Addiction to alcohol or drugs during addiction treatment
Other illness
- Known cognitive disorder (Mini Mental State Evaluation \<23 for more than 65 years)
- Known psychotic personality disorder
- Cancer undergoing chemotherapy
- Compulsive eating disorders
Other
- 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 schizophrenia
- Suicide attempt or suicidal ideation
- Pathological grieving process
- No understanding of French
- Unaided deafness
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CH Angers Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| CH Bayonne Coordinator of this site? Confirm its status | Bayonne | France | Unknown status |
| CHRU de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| AIRBP 28 Coordinator of this site? Confirm its status | Chartres | France | Unknown status |
| AURAD Aquitaine Coordinator of this site? Confirm its status | Gradignan | France | Unknown status |
| CHD Vendée Coordinator of this site? Confirm its status | La Roche-sur-Yon | France | Unknown status |
| ECHO Nantes Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| ATTIRO Orléans Coordinator of this site? Confirm its status | Orléans | France | Unknown status |
| CHRU de Tours Coordinator of this site? Confirm its status | Tours | France | Unknown status |
| CALYDIAL Coordinator of this site? Confirm its status | Vienne | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.