Music Interventions for Patients Undergoing Hemodialysis

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Pilot Study Evaluating the Effect of Patient-tailored Live Music Interventions for Patients Undergoing Hemodialysis

Conditions
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Renal Failure

Intervention / Treatment
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* Other: Music Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18+ Scheduled to receive hemodialysis treatment Able to understand written and spoken Danish Exclusion Criteria: Deafness Severe mental illness
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Patients in the intervention group will receive 30 minutes of patient-tailored instrumental music in the beginning of one weekly hemodialysis treatment for a period of six weeks | Other: Music Intervention<br>* 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<br>|
| No Intervention: Control group<br>The procedure in the control group is the same as in the intervention group, except that they don't listen to music | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate fatigue | Visual Analogue Scale (VAS). Higher VAS score means higher levels of 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). | 
| Longterm fatigue | Multidimensional Fatigue Inventory (MFI-20). Higher MFI-20 score means higher levels of fatigue | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relaxation | Visual Analogue Scale. Higher VAS score means higher levels of 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) | 
| Anxiety and Depression | Hospital Anxiety Depression Scale (HADS). Higher HADS score means higher levels of anxiety and depression | 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 | 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 | Change from baseline work engagement at 8 weeks. UWES is measured at baseline (visit 1) and at follow-up (visit 8) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Music intervention, Feasibility, Kidney failure, Mixed method, Renal dialysis, Randomized Controlled Pilot Study