Music Interventions for Patients Undergoing Hemodialysis
A Randomized Controlled Pilot Study Evaluating the Effect of Patient-tailored Live Music Interventions for Patients Undergoing Hemodialysis
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.
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Odense, Danmark, 5000
- Margrethe Langer Bro
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age 18+
- Scheduled to receive hemodialysis treatment
- Able to understand written and spoken Danish
Exclusion Criteria:
- Deafness
- Severe mental illness
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Intervention group
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
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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
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Ingen indgriben: Control group
The procedure in the control group is the same as in the intervention group, except that they don't listen to music
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Immediate fatigue
Tidsramme: 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).
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Visual Analogue Scale (VAS).
Higher VAS score means higher levels of fatigue
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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).
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Longterm fatigue
Tidsramme: Change from baseline longterm fatigue at 8 weeks. MFI-20 is measured at baseline (visit 1) and at follow-up (visit 8)
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Multidimensional Fatigue Inventory (MFI-20).
Higher MFI-20 score means higher levels of fatigue
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Change from baseline longterm fatigue at 8 weeks. MFI-20 is measured at baseline (visit 1) and at follow-up (visit 8)
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Post-dialysis fatigue-diary
Tidsramme: 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
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Visual Analogue Scale (VAS).
Higher VAS score means higher levels of fatigue
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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
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Relaxation
Tidsramme: 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)
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Visual Analogue Scale.
Higher VAS score means higher levels of relaxation
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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)
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Anxiety and Depression
Tidsramme: Change from baseline anxiety and depression at 8 weeks. HADS is measured at baseline (visit 1) and follow-up (visit 8)
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Hospital Anxiety Depression Scale (HADS).
Higher HADS score means higher levels of anxiety and depression
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Change from baseline anxiety and depression at 8 weeks. HADS is measured at baseline (visit 1) and follow-up (visit 8)
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Treatment satisfaction
Tidsramme: Change from baseline treatment satisfaction at 8 weeks. VAS is measured at baseline (visit 1) and at follow-up (visit 8)
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Visual Analogue Scale (VAS).
Higher VAS score means higher levels of treatment satisfaction
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Change from baseline treatment satisfaction at 8 weeks. VAS is measured at baseline (visit 1) and at follow-up (visit 8)
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Work engagement (staff)
Tidsramme: 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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Utrecht Work Engagement Scale (UWES).
Higher UWES score means higher levels of work engagement
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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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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Pia Dreyer, PhD, Institute of Public Health, University of Aarhus
- Studiestol: Bibi Gram, PhD, Regional Health Research, University of Southern Denmark
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Music & Hemodialysis
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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