Renal Failure
Conditions
Keywords
Music intervention, Feasibility, Kidney failure, Mixed method, Renal dialysis, Randomized Controlled Pilot Study
Brief summary
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.
Interventions
OTHERMusic Intervention
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
Sponsors
The Royal Academy of Music Aarhus/Aalborg
Aarhus University Hospital
University of Aarhus
Hanze University of Applied Sciences Groningen
University of Music and Performing Arts, Vienna
University Hospital of Southern Denmark
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Age 18+ * Scheduled to receive hemodialysis treatment * Able to understand written and spoken Danish
Exclusion criteria
* Deafness * Severe mental illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immediate fatigue | 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). | Visual Analogue Scale (VAS). Higher VAS score means higher levels of fatigue |
| Longterm fatigue | Change from baseline longterm fatigue at 8 weeks. MFI-20 is measured at baseline (visit 1) and at follow-up (visit 8) | Multidimensional Fatigue Inventory (MFI-20). Higher MFI-20 score means higher levels of fatigue |
| Post-dialysis fatigue-diary | 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 | Visual Analogue Scale (VAS). Higher VAS score means higher levels of fatigue |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relaxation | 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) | Visual Analogue Scale. Higher VAS score means higher levels of relaxation |
| Work engagement (staff) | Change from baseline work engagement at 8 weeks. UWES is measured at baseline (visit 1) and at follow-up (visit 8) | Utrecht Work Engagement Scale (UWES). Higher UWES score means higher levels of work engagement |
| Anxiety and Depression | Change from baseline anxiety and depression at 8 weeks. HADS is measured at baseline (visit 1) and follow-up (visit 8) | Hospital Anxiety Depression Scale (HADS). Higher HADS score means higher levels of anxiety and depression |
| Treatment satisfaction | Change from baseline treatment satisfaction at 8 weeks. VAS is measured at baseline (visit 1) and at follow-up (visit 8) | Visual Analogue Scale (VAS). Higher VAS score means higher levels of treatment satisfaction |
Countries
Denmark
Outcome results
None listed