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

NCT07054112 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-07-08

No results posted yet for this 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.

Conditions

  • Chronic Kidney Disease Requiring Hemodialysis

Interventions

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • University Hospital, Tours

    lead OTHER

Principal Investigators

  • Marine NAUDIN, PhD · CHRU de Tours

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2026-11-30
Completion
2027-07-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07054112 on ClinicalTrials.gov