Fatigue is found to be one of the most persistent problems among patients in treatment with hemodialysis, and associated with impaired health-related quality of life. A few, non-randomized controlled trials have found positive effects on fatigue by offering pre-recorded music intra-dialytic, however, without conclusive results. So far, no studies have investigated the feasibility of integrating person-tailored live music interventions performed by professional musicians into a hemodialysis setting. This leaves a deficit in knowledge for intervention planning, understanding and effectiveness of live music on fatigue, wellbeing and feelings of meaningfulness in this group of patients. Methods: A pilot randomized controlled trial combined with qualitative methods. The data collection will involve recruitment of 24 patients from an outpatient clinic over a six-week period. The patients will be randomized into either an intervention group or a control group. Patients in the intervention group will be offered a 30-minute session of patient-tailored live music intervention per week for six consecutive weeks. Patients in the control group will receive standard care. Quantitative analysis on immediate post-dialysis fatigue (VAS), and long-term fatigue (MFI-20), anxiety, depression (HADS) and treatment satisfaction (VAS) will show the potential effectiveness of intervention. Qualitative analysis of informal-interviews (patients/staff), observational data (patients) and focus group interviews (staff/musicians) will explore an in-depth understanding of whether music will improve wellbeing and create feelings of meaningfulness among this group of patients as well as to assess feasibility acceptability among patients, musicians and staff. Perspectives: This trial will ensure a firm methodological approach for the development of a future definitive randomized controlled trial of music intervention for fatigue reduction and wellbeing among hemodialysis patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
24
After rating levels of fatigue and relaxation, the professional health care musicians will play 30 minutes of patient-tailored, pleasant instrumental music with a combination of relaxing (on average 60-80 bpm) and lively, slightly more up-beat tempo to regulate arousal-levels
Margrethe Langer Bro
Odense, Denmark
Immediate fatigue
Visual Analogue Scale (VAS). Higher VAS score means higher levels of fatigue
Time frame: Change from baseline immediate fatigue at 8 weeks. VAS is measured at baseline (visit 1), after visit 2, visit 3, visit 4, visit 5, visit 6, visit 7 and at follow-up (visit 8).
Longterm fatigue
Multidimensional Fatigue Inventory (MFI-20). Higher MFI-20 score means higher levels of fatigue
Time frame: Change from baseline longterm fatigue at 8 weeks. MFI-20 is measured at baseline (visit 1) and at follow-up (visit 8)
Post-dialysis fatigue-diary
Visual Analogue Scale (VAS). Higher VAS score means higher levels of fatigue
Time frame: Change from baseline post dialysis fatigue at 8 weeks. Post-dialysis fatigue is measured the day after visit 2, visit, 3, visit 4, visit 5, visit, 6
Relaxation
Visual Analogue Scale. Higher VAS score means higher levels of relaxation
Time frame: Change from baseline relaxation at 8 weeks. VAS is measured at baseline (visit 1), after visit 2, visit 3, visit 4, visit 5, visit 6, visit 7 and at followup (visit 8)
Anxiety and Depression
Hospital Anxiety Depression Scale (HADS). Higher HADS score means higher levels of anxiety and depression
Time frame: Change from baseline anxiety and depression at 8 weeks. HADS is measured at baseline (visit 1) and follow-up (visit 8)
Treatment satisfaction
Visual Analogue Scale (VAS). Higher VAS score means higher levels of treatment satisfaction
Time frame: Change from baseline treatment satisfaction at 8 weeks. VAS is measured at baseline (visit 1) and at follow-up (visit 8)
Work engagement (staff)
Utrecht Work Engagement Scale (UWES). Higher UWES score means higher levels of work engagement
Time frame: Change from baseline work engagement at 8 weeks. UWES is measured at baseline (visit 1) and at follow-up (visit 8)
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