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Clinical Trials in France / NCT07054112
Starting soon Not applicable

Efficacy of Live Online Course Mindfulness Program on Perceived Fatigue in Hemodialysis Patients

NCT07054112 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Tours
Phase
Not applicable
Started
2025-09-30
Last updated
2025-07-08

Condition(s) studied

Chronic Kidney Disease Requiring Hemodialysis

Investigational drug(s) / intervention(s)

Mindfulness-Based Stress Reduction (MBSR) meditation programControl group

Mindfulness-Based Stress Reduction (MBSR) meditation program: 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 group: 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in the SONG-HD fatigue scale between baseline and 2 months follow-up. — 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

Trial sites (10)

FacilityCityRegionStatus
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 France
CALYDIAL Vienne France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07054112 on ClinicalTrials.gov ↗ ← All trials in France