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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Mindfulness-Based Stress Reduction (MBSR) meditation program
Other interventionThe 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
Other interventionPatients 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupOther 1 intervention
Trial outcomes
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
Time frame
Between baseline and 2 months follow-up.Secondary outcomes
1
Evolution of the score on the SONG-Fatigue scale between baseline, M2, M8 and M10
SONG-HD scale means Standardised Outcomes in Nephrology-Haemodialysis; The score will vary from 0 to a maximum of 9
Time frame
between baseline, Month-2, Month-8 and Month-102
Evolution of MFI score between baseline, M2, M8
MFI means Multidimensional Fatigue Inventory. The score will vary from 0 to a maximum of 100
Time frame
between baseline, Month-2, Month-83
Evolution of quality of life (KDQOL) at baseline, M2, M8
KDQOL means Kidney Disease Quality of Life
Time frame
at baseline, Month-2, Month-84
Evolution of anxiety (HAD) between baseline, M2, M8
HAD means Hospital Anxiety and Depression scale. The HAD scale is a screening instrument for anxiety and depressive disorders. It comprises 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven to depression (total D), giving two scores (maximum score for each = 21).
Time frame
between baseline, Month-2, Month-8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: