Efficacy of Live Online Course Mindfulness Program on Perceived Fatigue in Hemodialysis Patients
MEDIA
1 other identifier
interventional
80
1 country
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2025
Typical duration for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2025
CompletedFirst Posted
Study publicly available on registry
July 8, 2025
CompletedStudy Start
First participant enrolled
September 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2027
July 8, 2025
June 1, 2025
1.2 years
June 13, 2025
July 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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
between baseline, Month-2, Month-8 and Month-10
Evolution of MFI score between baseline, M2, M8
between baseline, Month-2, Month-8
Evolution of quality of life (KDQOL) at baseline, M2, M8
at baseline, Month-2, Month-8
Evolution of anxiety (HAD) between baseline, M2, M8
between baseline, Month-2, Month-8
Evolution of Mindfulness Score (FFMQ) between baseline, M2 and M8
between baseline, Month-2 and Month-8
- +3 more secondary outcomes
Study Arms (2)
Experimental group
EXPERIMENTALPatients receive an MBSR (Mindfulness on Stress Reduction) meditation program delivered by a certified instructor.
Control group
OTHERPatients 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
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
CH Angers
Angers, France
CH Bayonne
Bayonne, France
CHRU de Bordeaux
Bordeaux, France
AIRBP 28
Chartres, France
AURAD Aquitaine
Gradignan, France
CHD Vendée
La Roche-sur-Yon, France
ECHO Nantes
Nantes, France
ATTIRO Orléans
Orléans, France
CHRU De Tours
Tours, 37000, France
CALYDIAL
Vienne, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marine NAUDIN, PhD
CHRU de Tours
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2025
First Posted
July 8, 2025
Study Start
September 30, 2025
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
July 30, 2027
Last Updated
July 8, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share