Efficacy of Live Online Course Mindfulness Program on Perceived Fatigue in Hemodialysis Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Tours
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Mindfulness-Based Stress Reduction (MBSR) meditation program
- Control group
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov